Clinical

Insmed Incorporated

Director, Pharmacovigilance / Product Safety

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Director, Pharmacovigilance / Product Safety on the Drug Safety & Pharmacovigilance team to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, DSPV Medical Safety, you’ll be the DSPV expert for assigned products; maintaining current knowledge of assigned product portfolio and safety profiles for products.

You will be responsible for safety surveillance, risk management, and risk communication for assigned development and marketed products as well as medical assessment of individual adverse event reports, generation, and review of aggregate reports and safety documents, including labeling changes.

**What You'll Do:**

In this role, you’ll have the opportunity to review of all safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process as well as post marketing for assigned products and development compounds. You’ll also:

- Be responsible for conducting safety signal detection activities, monitoring, evaluation, interpretation and appropriate management and communication of safety information
- Have leadership of the Safety Review Team(s) for assigned products and development compounds, and responsible for the management of ongoing and cross functional assessment of benefit risk profiles and related actions, including writing and updating of the benefit-risk documents such as Safety Signal Assessment Reports for assigned products and development compounds
- Lead the development and management of a comprehensive risk management system for risk detection, risk assessment and risk minimization for assigned products.
- Provide medical expert safety review input into all critical documents for clinical development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs).
- Work with the Head of DSPV to develop the strategy and implementation of safety and benefit-risk management for assigned products.
- Direct and collaborate on the development of product specific Risk Evaluation and Mitigation Strategy (REMS) in the event needed for assigned products.
- Ensure Risk Management System, Risk Management Plans (RMPs) for marketed and developmental products and Risk Minimization Measures (RMMs) are compliant with US, EU and International regulations and standards including ICH and EU GVP.
- Provide input into and support the writing of periodic reports for assigned products; provide medical interpretation, review and approval for required reports.
- Share DSPV and medical expertise on assigned products with global counterparts in other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Medical Information, Marketing, Manufacturing, and Legal.
- Provide expert safety input to the clinical development program for assigned products and development compound.

**Who You Are:**

You have an MD or DO along with 2 years of Clinical Patient Care experience, 5 years of experience in pharmaceutical industry within Drug Safety/Pharmacovigilance with both investigational and marketed products and 3 years of experience with medical case reviews, aggregate reporting, safety surveillance, signal management and/or risk management. You are or also have:

- The ability to review and or prepare, scientific or regulatory documents, from large volumes of scientific information
- Knowledge and understanding of national & international PV and regulatory guidelines
- Ability to present drug safety topics for regulatory authorities at conventions, meetings, etc. Product defense before a national or international regulatory authority a plus
- Drug safety database knowledge preferred
- Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat computer skills

**Where You’ll Work**

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.

**Travel Requirements:**

This position involves occasional US and domestic travel - up to 20%.

\#LI-TB1

\#LI-Remote

**Pay Range:**

$247,000.00-337,000.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Nationwide

Director, Drug Safety & Pharmacovigilance - Japan

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

Working with the Head of DSPV-Japan, this role is responsible for ensuring optimal patient safety as first priority by developing a state-of-the-art safety strategy, driving medical safety processes and capabilities and having accountability for safety compliance in Japan.

**What You'll Do:**

- Develop and maintain a local safety assurance system to support safe use of commercial product
- Conduct or supervision of safety assurance activities, including but not limited to, collection of drug safety reports, examination of safety information received, timely reporting to competent authorities and planning, reporting and implementation of safety assurance measures
- Conduct self-inspection and support internal process audits and external vendor audits as necessary
- Contribution to and control of documents related to safety management activities, including, but not limited to, the J-RMP and the J-PSUR
- Development of local SOPs related to safety assurance activities, review or approval of functional area procedures as needed and implementation of associated training requirements
- Providing Head of DSPV-Japan with information on changes in the local GVP regulations Communication with necessary parties in the case of communication from the local competent authorities regarding safety matters for the product
- Reporting of any product safety related issues to Head of DSPV-Japan, and the General Marketing Compliance Officer in Japan
- Play a key role in cross-functional project for investigational product from development phase including J-NDA through launch, collaborating with colleagues from other functions, e.g. Clinical Development, Medical Affairs, Regulatory Affairs, Medical Information, and QA, as well as externally with expert panels and other scientific contacts
- Enhance scientific and clinical experience of staff through continuous training and coaching. Participates in building the talent pipeline for key roles in Medical Safety. Responsible for attracting, retaining and developing talent within the PV organization.
- Collaborate with/support medical safety for medical review and safety assessment activities, including, but not limited to, compiling analysis of similar events (AOSE), individual case comments, RMP analyses, and ad-hoc safety analyses as required by health authorities or corporate policy, and ensure that medical safety signals from aggregate data are identified promptly and communicated/escalated within the PV organization and other functions appropriately
- Lead enhancement/improvement of operational process to optimize the efficiency in the organization as necessary

**Who You Are:**

- Bachelor’s degree in health care or life science is required, Master’s degree is preferrable
- Must have excellent communication and presentation skills (verbal and written / Japanese and English) with the ability to effectively present ideas and influence others that achieve desired results
- Minimum eight (8) years in Drug safety/Pharmacovigilance in pharmaceutical industries setting with both investigational and marketed products. Working knowledge of relevant PMDA, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments (including ICH/CIOMS, Clinical development methodology and knowledge of Clinical Trial guidelines (GCP) and regulation)
- Knowledge of Individual Case Safety Reports (ICSR) management processes including case receipt, case processing, medical review, and regulatory submission
- At least two (2) years of experience with, aggregate safety reporting, safety surveillance, signal management and/or Risk management
- Active participation in internal audits, regulatory inspections
- People management and resource/budget planning experience
- Preferrable experience of: Minimum two (2) years as a safety officer; Knowledge of pharmacoepidemiology; Ability to review and/or prepare scientific or regulatory documents, from large volumes of scientific information; Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/ submissions involving safety information; Experience in presenting clinical or safety data to major health authorities; Experience with setting up and leading an Early Post-marketing Vigilance Study; Working knowledge of industry standard pharmacovigilance databases (preferably Argus) and MedDRA; Device experience; Project management experience
- Skills & Capabilities: Ability to lead others without authority to move internal and external teams towards achieving goals that support Insmed’s key strategic objectives; Demonstrated experience improving, developing and implementing new processes; Flexible, diplomatic and able to effectively deal with ambiguity; Works effectively across functions as a team player; Successful experience in a fast-paced entrepreneurial environment; Highly organized with strong attention to detail, clarity, accuracy, and conciseness; An uncompromising ethical standard and level of conduct are essential

**WhereYou’llWork**

The Company’s Head Offi ce in Tokyo - You may work from home according to the guidelines set forth by the Company

**Travel Requirements**

This role requires occasionaldomestic/internationaltravel (approximately20%)

**Life at Insmed**

インスメッド日本オフィスは、国会議事堂を望む東京の中心部、溜池山王駅直結の好立地に位置しています。最新のワークスタイルに対応したフリーアドレス制を導入し、開放的で柔軟な働き方を実現しています。カフェエリアでは部門を超えた自由なコミュニケーションやコラボレーションを促進する空間を創り出しています。

日本法人の拠点として、患者さんにより良い医療をお届けするため、社員一同が一丸となって日々邁進しています。

社員一人一人の充実した働き方を実現するためのサポート：

• ワークライフバランスの実現

フレキシブルな勤務時間や充実した休暇制度

• 魅力的な報酬制度

退職金制度、株式報酬制度、従業員持株制度（ESPP）への参加機会

• キャリア開発支援

社内研修、外部研修プログラムの活用、LinkedIn Learning、業務に特化した専門研修

• 先進的な学習支援

AI搭載の学習ツール、社内リソースへのアクセスを支援するデジタルアシスタント

• グローバルの表彰制度や従業員リソースグループ活動

• ハイブリッドワーク環境の整備

場所や時差を超えたシームレスな協働を実現する最新テクノロジー、充実したIT支援体制

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, age, or any other characteristic protected by law.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Other Non-US

Summer Intern - Gene Editing Discovery

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Summer Intern - Gene Editing Discovery on the Research Team to help us expand what’s possible for patients with serious diseases.

The Insmed Summer Internship Program is designed to give you more than just a glimpse into the pharmaceutical industry—it’s a chance to make a real impact. Over the course of the summer, you’ll gain hands-on experience, contribute to meaningful team projects, and learn directly from skilled professionals who are invested in your growth.

Our 2027 Summer Intern program is a full-time (40 hours per week), 12-week, paid internship. The internship may present opportunities for rotational assignments within the function, and the intern will be assigned goals and objectives that will support the strategic business plan of the company.

**What You'll Do:**

In this role, you'll have the opportunity to help advance Insmed's gene editing research pipeline.

You’ll also:

- Participate in gene editing experiments (e.g., CRISPR-based knockouts or knock-ins) under mentor supervision
- Perform molecular biology workflows and assays to validate editing outcomes (e.g., cloning, Western blot, PCR, flow cytometry)
- Maintain detailed and accurate lab notebooks and experimental records
- Analyze and interpret experimental results, contribute to data presentations and team meetings
- Collaborate with scientists across discovery and bioinformatics teams
- Present a summary of internship findings at the end of the program

**Who You Are:**

You are a current student working on a BS, MS, or PhD program in Molecular Biology, Biochemistry, Genetics, Bioengineering, or a related field.

You are or you have:

- Hands-on coursework or lab experience in molecular biology techniques (e.g., PCR, cloning) and cell culture
- Familiarity with CRISPR/Cas9 or other gene editing platforms (preferred)
- Basic understanding of DNA repair mechanisms (NHEJ, HDR) and genome biology (preferred)
- Strong analytical and problem-solving skills; ability to interpret experimental data
- Effective written and verbal communication skills for scientific reporting
- Ability to work collaboratively in a fast-paced, multidisciplinary research environment

**Where You’ll Work**

This role is based out of our Bridgewater, New Jersey Research Development Lab and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.

**Pay Range:**

$20.00-35.00 Hourly

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. Our internship program reflects that commitment by supporting how you learn, grow, and show up each day while contributing to work that matters.

Our internship offerings include:

- Paid company holidays
- Hands-on learning in real-world projects
- Networking opportunities with leaders and social events with your peers
- Mentorship and professional development
- A final presentation to celebrate your contributions
- Access to office amenities for those who are not remote

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

[*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

New Jersey

Manager, Project Management – Technical Operations

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Manager, Project Management – Technical Operations on the Technical Operations Project & Strategy team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, Technical Operations - Project Management, you’ll be a critical contributor within Insmed’s Technical Operations Department, responsible for driving complex pipeline projects from research transition through development, registration, and commercial readiness. This role leads cross-functional Chemistry, Manufacturing & Controls (CMC) teams and collaborates with internal departments and external partners to ensure timely, high-quality project delivery.

**What You'll Do:**

In this role, you’ll have the opportunity to lead project teams internal to the company and with external partners, fostering a collaborative culture that supports team effectiveness, motivation, and accountability. You’ll also:

- Guide the progression of programs from Research into Technical Operations, through development, regulatory submission, launch, and post-launch lifecycle management.
- Serve as a key integrator, aligning functions such as Manufacturing, Analytical Development, Quality Assurance, and Regulatory Affairs, with input from Commercial, Research, and Clinical to ensure unified execution of project goals.
- Establish and drive structured project frameworks, ensuring clarity of roles, deliverables, and decision-making processes across cross-functional teams.
- Proactively identify risks and opportunities, develop mitigation strategies with technical experts, and escalate critical issues to ensure timely and informed decision-making.
- Deliver strong project planning, milestone tracking, and transparent communication, keeping teams and leadership aligned on progress, priorities, and shifts in strategy.
- Champion project management excellence by deploying tools, visuals, and metrics that bring cohesion, visibility, and strategic alignment to the broader Technical Operations organization.
- Support the application of project management tools and approaches beyond the PM function, enabling stakeholders across the organization to improve planning and execution.
- Represent Technical Operations in cross-functional meetings and governance forums, contributing to operational strategy and execution alignment.
- Support budget planning and resource forecasting in collaboration with Technical Operations leadership.
- Maintain communication and relationships with CDMOs and external partners to ensure alignment on timelines and deliverables.
- Contribute to a high-performing, people-centered project management culture that emphasizes clear communication, shared success, and continuous improvement.

**Who You Are:**

You have a Bachelor’s degree along with five years of experience in pharmaceutical, biotech, or medical device industry. You are or you also have:

- Proven ability to lead cross-functional teams and drive accountability without direct authority
- Strong communication, collaboration, and organizational skills
- Experience managing projects across the product lifecycle—from development through launch
- Proficiency with project management tools (e.g., MS Project, Excel, PowerPoint, SharePoint, Smartsheet)
- Ability to adapt and thrive in fast-paced, regulated environments

**Nice to have (but not required):**

- PMP certification
- Working knowledge of the full drug development process (e.g., Research, Clinical, Regulatory, Manufacturing, Quality)
- Entrepreneurial mindset and continuous improvement orientation

**Where You’ll Work**

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.

**Travel Requirements**

This position involves frequent domestic and/or international travel (up to 20%).

\#LI-BA

\#LI-REMOTE

**Pay Range:**

$124,000.00-161,000.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Vice President and Global Head of Drug Safety and Pharmacovigilance

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Vice President and Global Head of Drug Safety and Pharmacovigilance (DSPV) to help us expand what’s possible for patients with serious diseases. Reporting to the Chief Medical Officer, the Vice President and Global Head of DSPV will lead the global pharmacovigilance team to improve patients' lives and drive Insmed's overall mission through robust safety evaluation expertise and medical innovation.

This role is responsible for ensuring optimal patient safety as the first priority by developing state-of-the-art safety strategy, driving medical safety processes and capabilities, and maintaining full accountability for safety compliance across all global markets.

The incumbent will provide leadership and oversight of the entire DSPV organization, including Medical Safety, EMEA QPPV operations, Japan PV operations, and DSPV Operational Excellence and Compliance functions. A key priority for this leader is the delivery of an enterprise-wide strategic initiative to transform Insmed's global PV infrastructure, processes, and technology ecosystem to be best in class.

**What You'll Do:**

In this role, you’ll have the opportunity to set strategic direction for the global DSPV organization and develop & execute a multi-year PV roadmap aligned with Insmed's pipeline and commercial growth. You’ll also have responsibilities across:

**Strategic Leadership**

- Lead enterprise transformation programs, including a current strategic initiative, ensuring stakeholder alignment and full implementation.
- Attract, develop, and retain top PV talent to build a high-performing, globally diverse team.
- Represent Insmed externally at regulatory forums, industry associations, and scientific conferences.

**Safety Science & Medical Oversight**

- Oversee global safety surveillance, signal detection, and risk management for all Insmed products.
- Ensure timely, high-quality medical safety deliverables and benefit-risk communications aligned with FDA, EMA, and PMDA frameworks.
- Champion integration of AI/ML, advanced analytics, and real-world evidence into PV workflows.
- Maintain deep expertise in rare disease safety science, including small patient population signal detection.

**Global Regulatory Compliance**

- Ensure compliance with global PV regulations (GCP, GVP, GMP, ICH) across all markets; maintain inspection readiness.
- Support the EU/UK QPPV and oversee EMEA and Japan PV operations.
- Lead REMS and global Risk Management Plan (RMP) development and negotiation.
- Represent DSPV in interactions with FDA, EMA, PMDA, and other health authorities.

**Operational Excellence & Digital Innovation**

- Drive implementation of an enterprise-wide strategic initiative, including PV system modernization and global workflow standardization.
- Govern a PV Technology and Innovation roadmap; evaluate and implement next-generation safety platforms and AI-assisted tools.
- Develop and track DSPV KPIs and quality metrics; manage global PV budget and vendor ecosystem.
- Ensure business continuity for all critical PV processes.

**Cross-Functional & External Engagement**

- Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, Commercial, Quality, and Legal/Compliance.
- Serve as executive sponsor and cross-functional liaison for the enterprise-wide strategic initiative.
- Engage with patient advocacy organizations, rare disease consortia, and industry working groups (DIA, ISOP, BIO, EFPIA).

**Who You Are:**

You **must** have an MD with 15+ years of drug development experience within a pharmaceutical or biotech company, 10+ years of pharmacovigilance (PV)/drug safety leadership, and a minimum of 5 years’ experience as a VP or equivalent with full PV organizational accountability. Additionally, you have:

- Demonstrated experience as the head of a global PV organization, with ownership of safety strategy, compliance, operations, and team performance.
- A proven track record building, scaling, and transforming PV organizations through periods of significant change.
- 4+ years post-doctoral clinical experience.
- FDA and EMA inspection leadership; experience as or supporting EU/UK QPPV.
- Experience leading large-scale PV transformation or technology modernization programs and familiarity with AI/ML applications in pharmacovigilance.
- Experience with BLA/NDA/MAA/JNDA submissions and health authority interactions (FDA, EMA, PMDA).
- Exceptional executive leadership ability to inspire, coach, and develop globally distributed teams.
- Proven ability to lead through influence; demonstrated executive gravitas and leadership presence.
- Strong negotiation, conflict management, and cross-functional collaboration skills.
- Financial acumen to drive global budget management, vendor governance, and KPI development.
- Excellent communication; able to present complex safety data to Boards, health authorities, and senior leadership.
- Proficiency in PV databases (ARISg, Oracle Argus, Veeva Vault Safety), MedDRA coding, and Microsoft Office Suite.
- A commitment to inclusive leadership and diverse, equitable team building.

**Nice to have (but notrequired):**

- Specialty Board Certification.
- An advanced degree, in addition to an MD, in Pharmaceutical Medicine, Epidemiology/Public Health, or Regulatory Science is strongly preferred.
- Rare disease experience is strongly preferred.

**Where You’ll Work**

This is a fully remote role. It can be performed effectively from anywhere while staying connected to yourInsmedteam and community.Travel for team meetings or eventswillbe expected.

**Travel Requirements**

This position involves frequent domestic and/or international travel (approximately 25%).

\#LI-MM1

\#LI-Remote

**Pay Range:**

$365,000.00-497,000.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Specialist, Quality CMC Operations

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

Reporting to the Sr. Director, Quality CMC, the Quality Specialist will play a key role in executing QA activities for Insmed supporting Phase 1- 3 pipeline products. Specific areas of responsibility include Batch Record Review, Product Release process, CoA review, CoR generation, QA Metric monitoring, in addition to other QA related activities.

**What You'll Do:**

In this role, you’ll have the opportunity to perform batch disposition activities, including reviewing and approving batch records, certificates of analysis, and other relevant documentation for pipeline drug substance, drug product and medical devices.

You’ll also:

- Generate certificate of releases, create lots in electronic system and upload all required documents for internal and external stakeholders.
- Ensure compliance with all relevant regulations and guidelines related to pharmaceutical quality and batch disposition.
- Collaborate with cross-functional teams to resolve quality-related issues and ensure timely release of products.
- Drive continuous improvement initiatives to enhance the efficiency and effectiveness of quality assurance and batch disposition processes.
- Develop and maintain standard operating procedures (SOPs) for batch disposition and quality assurance processes.
- Communicate with external suppliers and internal stakeholders regarding quality-related matters.
- Maintain accurate and organized records of all quality assurance and batch disposition activities.
- Participate in cross-functional projects and provide quality assurance expertise and support, as needed.
- Partner with Quality CMC team members and colleagues in other departments to increase the overall effectiveness of the Quality Assurance department and build supportive, productive relationships.

**Who You Are:**

You have aminimumof a Bachelor's degree in Chemistry, Life Science or related discipline as well as at least 3 years’ experience working in a pharmaceutical company. You are or also have:

- Familiarity of pharmaceutical product manufacturing processes, medical devices, and analytical laboratory practices.
- Demontrated experience working with an electronic document management system.
- Must be knowledgeable on cGMP's and other regulatory requirements applicable to GMP product manufacturing operation and release.
- Proven experience in batch records review and product release process
- Demonstrate ability to manage projects and variable workloads.
- Must have excellent communication skills (verbal and written).
- Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Knowledge of Veeva Quality Vault system is highly desirable.

**WhereYou’llWork**

This is a hybrid role based out of ourBridgewater, NJ office.You’llhave theoptiontowork remotely most of the time, with in-person collaborationwhen it matters most.

**Travel Requirements**

This role requires occasionaldomestic/internationaltravel (approximatelyup to 10%).

\#LI-hybrid

\#LI-EG1

**Pay Range:**

$39.00-50.00 Hourly

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Summer Intern – Clinical Supply Chain and Logistics

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Clinical Supply Chain and Logistics Intern on the Supply Chain team to help us expand what’s possible for patients with serious diseases.

The Insmed Summer Internship Program is designed to give you more than just a glimpse into the pharmaceutical industry—it’s a chance to make a real impact. Over the course of the summer, you’ll gain hands-on experience, contribute to meaningful team projects, and learn directly from skilled professionals who are invested in your growth.

Our 2027 Summer Intern program is a full-time (40 hours per week), 12-week, paid internship. The internship may present opportunities for rotational assignments within the function, and the intern will be assigned goals and objectives that will support the strategic business plan of the company.

**What You'll Do:**

In this role, you’ll have the opportunity to work cross functionally with Clinical Supply Chain & Logistics customers internal and external to the organization and expected to be collaborative and communicative.

You'll also:

- Work across the clinical supply chain team to gain high level knowledge on all therapeutic areas, and general supply chain strategies that can be applied to future scenarios within the field
- Assist supply chain colleagues in the clinical study startup processes such as demand forecasting, regulatory submissions, and vendor/contract management.
- Coordinate with the Clinical Supply Chain Team to create forecasts and scenario plans to determine proper manufacturing, packaging, and distribution strategies for multiple different products
- Working cross functionally with different departments other than supply chain to achieve FPI (First Patient In) milestones and successful clinical study start
- Assist in digital solutions to optimize scenario planning and supply forecasting using tools like specially designed Clinical forecasting software and AI solutions
- Collaborate with internal stakeholders to ensure consistent inventory is available at each node within the clinical supply chain.
- Identify risks in process management and develop a solution-based approach that is operationally achievable.

**Who You Are:**

You are a current student working on a bachelors or master's degree in Supply Chain or similar field.

You are or you have:

- Proficient with Microsoft Applications (Excel, PowerPoint, Word). MS Project and other computer software demand & supply related systems are a plus.
- Strong teamwork and collaboration skills.
- Strong ability to handle multiple projects simultaneously.
- Able to accomplish tasks with a sense of urgency.

**Where You’ll Work**

This is a hybrid role based out of our Bridgewater, New Jersey office. You’ll work remotely most of the time, with in-person collaboration when it matters most.

**Pay Range:**

$20.00-35.00 Hourly

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. Our internship program reflects that commitment by supporting how you learn, grow, and show up each day while contributing to work that matters.

Our internship offerings include:

- Paid company holidays
- Hands-on learning in real-world projects
- Networking opportunities with leaders and social events with your peers
- Mentorship and professional development
- A final presentation to celebrate your contributions
- Access to office amenities for those who are not remote

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

[*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Beeline Medicines

Clinical Engagement Lead - India

**About Beeline Medicines:**

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

**Job Summary:**

The Clinical Engagement Lead, is a field-based is a senior level, site facing clinical development professional responsible for building and managing investigator and site relationships across the globe in support of the organization's clinical trial portfolio. This role serves as the primary site-facing liaison between the organization and its global clinical investigators, academic medical centers, and research sites — supporting site identification, investigator engagement, and clinical trial execution to position the organization’s I&I programs competitively in the clinical research landscape. The Clinical Engagement Lead combines knowledge of the I&I therapeutic area with strong relationship management skills and a thorough understanding of clinical trial operations — serving as a trusted partner to investigators and a critical field intelligence link back to the internal Clinical Development and Medical Affairs teams. This is a highly visible, externally focused role that requires the ability to represent the organization’s science with authority, build lasting relationships with leading clinical researchers, and operate independently across a broad assigned geography.

**Work Arrangement & Location:**

**Field-Based -** This position is field-based, and the incumbent will be expected to work within their assigned territory or region on behalf of the company. Regular travel within the designated geography is an inherent requirement of this role. Additional travel outside of the assigned territory may be required based on business need, including attendance at company meetings, training, or other organizational events.

**Territory Assignment Notice:**

India and other APAC countries as assigned.

Notice: The geographic territory outlined for this position reflects current business needs and is subject to change at the discretion of the organization. Territory boundaries, state assignments, and regional alignments may be modified at any time based on evolving business priorities, organizational restructuring, or strategic initiatives. The selected candidate will be expected to adapt to any such changes as a condition of employment.

**Essential Duties and Responsibilities:**

- Build and manage a portfolio of region/country investigator and clinical site relationships in the I&I therapeutic area — identifying, engaging, and developing long-term partnerships with principal investigators, academic medical centers, community research sites, and subspecialty practices relevant to Beeline's clinical programs.
- Lead site identification and feasibility activities for clinical trials — conducting operational site assessments, evaluating investigator interest and patient population access, and providing strategic recommendations to Clinical Development and Clinical Operations on site selection and activation.
- Serve as the primary clinical liaison to regional/country level investigators — facilitating peer-to-peer scientific exchange on Beeline's pipeline, conducting protocol discussions, supporting site initiation and training, and maintaining ongoing engagement with investigators throughout the trial lifecycle.
- Support clinical trial enrollment and retention at region/country sites — working proactively with investigators and site staff to identify enrollment challenges, implement site-level solutions, and maintain site motivation and engagement across all active Beeline studies.
- Capture and communicate region/country clinical landscape intelligence — including investigator perspectives, competitive trial activity, site capacity trends, and unmet medical need insights — back to Clinical Development, Medical Affairs, and Commercial teams in a structured, actionable manner.
- Partner with Medical Affairs MSLs to ensure coordination and alignment of scientific engagement activities at the investigator level — establishing clear boundaries between clinical trial support and medical affairs activities and collaborating to maximize the impact of both.
- Represent organization clinical and scientific meetings, investigator symposia, disease-area conferences, and site visits — engaging with the clinical research community as a credible, knowledgeable, and trusted organizational representative.
- Develop and implement site engagement strategies to improve study start-up, enrollment performance, retention, and site satisfaction.
- Partner closely with investigators, study coordinators, and site staff to support patient identification and recruitment efforts.
- Provide operational guidance and best practices to sites related to diverse patient enrollment and community engagement.
- Conduct regular field engagement with investigative sites and community stakeholders to strengthen study execution and recruitment performance.
- Monitor enrollment trends, site performance metrics, and patient engagement effectiveness using data-driven approaches.
- Identify enrollment risks proactively and implement mitigation and recovery plans.
- Perform other duties and responsibilities as assigned.

**Qualifications:**

- Education: Bachelors degree in scientific or related discipline required. Advanced degree preferred—MS or MPH in a relevant clinical, biomedical, or pharmaceutical sciences discipline.
- 8+ years of experience in clinical development, clinical research, clinical operations, or a field-based clinical engagement role within the pharmaceutical or biotech industry.
- Demonstrated experience managing investigator relationships and supporting clinical trial site activation and enrollment.
- Experience in immunology, inflammation, or a related therapeutic area strongly preferred.
- Experience collaborating with CROs, investigative sites, and field medical teams, including MSL partnerships.
- Strong scientific and clinical knowledge of immunology and inflammation — including disease biology, standard of care, clinical trial design considerations, and the competitive clinical research landscape across relevant I&I indications.
- Expertise in clinical trial site management and investigator engagement — including site feasibility assessment, investigator identification and qualification, site initiation support, and enrollment optimization strategies.
- Working knowledge of GCP requirements, ICH guidelines, and FDA regulations governing investigator interactions, clinical site oversight, and field-based clinical development activities.
- Highly self-directed field professional — manages a complex investigator portfolio independently, prioritizes site engagement activities strategically, and operates with minimal supervision across a broad geography.
- Relationship-driven and trusted clinical trial resource — builds genuine, long-term partnerships with investigators and site staff based on scientific credibility, reliability, and authentic commitment to supporting research excellence.
- Proactive field intelligence contributor — consistently translates field observations into actionable insights that improve program strategy, site selection, and enrollment performance.
- Professional fluency in English (written and verbal) required
- Ability to safely and successfully operate a motor vehicle is required. Valid Driver’s License and a driving record in compliance with company standards
- Position may require ability to travel 50%+ as needed of time or more including occasional overnight stay driven by business need.
- Must be able to work evenings and weekends, as needed, for physician or patient events (both in person and virtual).
- Depending on geography, must have the ability to manage a multi-state territory with diverse customer base.

**Benefits:**

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

- Competitive health and wellness coverage (structure and premiums vary by country)
- Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
- Flexible work arrangements / hybrid schedule

*Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.*

**Equal Employment Opportunity:**

*Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.*

**Reasonable Accommodation:**

If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.

**Privacy**

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at [Privacy Policy - Beeline Medicines](<https://beelinemedicines.com/privacy-policy/>)

Clinical Engagement Lead - Japan

**About Beeline Medicines:**

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

**Job Summary:**

The Clinical Engagement Lead, is a field-based is a senior level, site facing clinical development professional responsible for building and managing investigator and site relationships across the globe in support of the organization's clinical trial portfolio. This role serves as the primary site-facing liaison between the organization and its global clinical investigators, academic medical centers, and research sites — supporting site identification, investigator engagement, and clinical trial execution to position the organization’s I&I programs competitively in the clinical research landscape. The Clinical Engagement Lead combines knowledge of the I&I therapeutic area with strong relationship management skills and a thorough understanding of clinical trial operations — serving as a trusted partner to investigators and a critical field intelligence link back to the internal Clinical Development and Medical Affairs teams. This is a highly visible, externally focused role that requires the ability to represent the organization’s science with authority, build lasting relationships with leading clinical researchers, and operate independently across a broad assigned geography.

**Work Arrangement & Location:**

**Field-Based -** This position is field-based, and the incumbent will be expected to work within their assigned territory or region on behalf of the company. Regular travel within the designated geography is an inherent requirement of this role. Additional travel outside of the assigned territory may be required based on business need, including attendance at company meetings, training, or other organizational events.

**Territory Assignment Notice:**

Japan and other APAC countries as assigned.

Notice: The geographic territory outlined for this position reflects current business needs and is subject to change at the discretion of the organization. Territory boundaries, state assignments, and regional alignments may be modified at any time based on evolving business priorities, organizational restructuring, or strategic initiatives. The selected candidate will be expected to adapt to any such changes as a condition of employment.

**Essential Duties and Responsibilities:**

- Build and manage a portfolio of region/country investigator and clinical site relationships in the I&I therapeutic area — identifying, engaging, and developing long-term partnerships with principal investigators, academic medical centers, community research sites, and subspecialty practices relevant to Beeline's clinical programs.
- Lead site identification and feasibility activities for clinical trials — conducting operational site assessments, evaluating investigator interest and patient population access, and providing strategic recommendations to Clinical Development and Clinical Operations on site selection and activation.
- Serve as the primary clinical liaison to regional/country level investigators — facilitating peer-to-peer scientific exchange on Beeline's pipeline, conducting protocol discussions, supporting site initiation and training, and maintaining ongoing engagement with investigators throughout the trial lifecycle.
- Support clinical trial enrollment and retention at region/country sites — working proactively with investigators and site staff to identify enrollment challenges, implement site-level solutions, and maintain site motivation and engagement across all active Beeline studies.
- Capture and communicate region/country clinical landscape intelligence — including investigator perspectives, competitive trial activity, site capacity trends, and unmet medical need insights — back to Clinical Development, Medical Affairs, and Commercial teams in a structured, actionable manner.
- Partner with Medical Affairs MSLs to ensure coordination and alignment of scientific engagement activities at the investigator level — establishing clear boundaries between clinical trial support and medical affairs activities and collaborating to maximize the impact of both.
- Represent organization clinical and scientific meetings, investigator symposia, disease-area conferences, and site visits — engaging with the clinical research community as a credible, knowledgeable, and trusted organizational representative.
- Develop and implement site engagement strategies to improve study start-up, enrollment performance, retention, and site satisfaction.
- Partner closely with investigators, study coordinators, and site staff to support patient identification and recruitment efforts.
- Provide operational guidance and best practices to sites related to diverse patient enrollment and community engagement.
- Conduct regular field engagement with investigative sites and community stakeholders to strengthen study execution and recruitment performance.
- Monitor enrollment trends, site performance metrics, and patient engagement effectiveness using data-driven approaches.
- Identify enrollment risks proactively and implement mitigation and recovery plans.
- Perform other duties and responsibilities as assigned.

**Qualifications:**

- Education: Bachelors degree in scientific or related discipline required. Advanced degree preferred—MS or MPH in a relevant clinical, biomedical, or pharmaceutical sciences discipline.
- 8+ years of experience in clinical development, clinical research, clinical operations, or a field-based clinical engagement role within the pharmaceutical or biotech industry.
- Demonstrated experience managing investigator relationships and supporting clinical trial site activation and enrollment.
- Experience in immunology, inflammation, or a related therapeutic area strongly preferred.
- Experience collaborating with CROs, investigative sites, and field medical teams, including MSL partnerships.
- Strong scientific and clinical knowledge of immunology and inflammation — including disease biology, standard of care, clinical trial design considerations, and the competitive clinical research landscape across relevant I&I indications.
- Expertise in clinical trial site management and investigator engagement — including site feasibility assessment, investigator identification and qualification, site initiation support, and enrollment optimization strategies.
- Working knowledge of GCP requirements, ICH guidelines, and FDA regulations governing investigator interactions, clinical site oversight, and field-based clinical development activities.
- Highly self-directed field professional — manages a complex investigator portfolio independently, prioritizes site engagement activities strategically, and operates with minimal supervision across a broad geography.
- Relationship-driven and trusted clinical trial resource — builds genuine, long-term partnerships with investigators and site staff based on scientific credibility, reliability, and authentic commitment to supporting research excellence.
- Proactive field intelligence contributor — consistently translates field observations into actionable insights that improve program strategy, site selection, and enrollment performance.
- Professional fluency in English (written and verbal) required
- Ability to safely and successfully operate a motor vehicle is required. Valid Driver’s License and a driving record in compliance with company standards
- Position may require ability to travel 50%+ as needed of time or more including occasional overnight stay driven by business need.
- Must be able to work evenings and weekends, as needed, for physician or patient events (both in person and virtual).
- Depending on geography, must have the ability to manage a multi-state territory with diverse customer base.

**Benefits:**

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

- Competitive health and wellness coverage (structure and premiums vary by country)
- Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
- Flexible work arrangements / hybrid schedule

*Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.*

**Equal Employment Opportunity:**

*Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.*

**Reasonable Accommodation:**

If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.

**Privacy**

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at [Privacy Policy - Beeline Medicines](<https://beelinemedicines.com/privacy-policy/>)

Senior Director, Clinical Pharmacology

**About Beeline Medicines:**

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

**Job Summary:**

The Senior Director, Clinical Pharmacology provides clinical pharmacology leadership across development programs, directing PK/PD strategy, modeling and simulation, and dose-selection activities to inform clinical trial design and regulatory submissions. Leads population PK, exposure-response, and other quantitative modeling efforts performed internally or through modeling vendors and translates the resulting insights into dose-selection rationale that shapes protocol design. Serves as the clinical pharmacology voice on cross-functional program teams and represents the function directly with health authorities during meetings and submission reviews. This role requires both technical modeling expertise and the credibility to defend clinical pharmacology strategy in high-stakes regulatory interactions.

**Work Arrangement & Location:**

**Hybrid -** This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as **Tuesday and Wednesday**. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

**Essential Duties and Responsibilities:**

- Lead clinical pharmacology strategy for assigned programs, including PK/PD study design and dose-selection rationale.
- Direct population PK, exposure-response, and modeling and simulation analyses performed internally or by vendors.
- Author and review clinical pharmacology sections of INDs, NDAs/BLAs, and health authority responses.
- Serve as clinical pharmacology lead on cross-functional program teams, advising on drug-drug interaction and special population studies.
- Represent clinical pharmacology in interactions with health authorities (e.g., FDA/CHMP meetings), including authorship of relevant sections of briefing documents.
- Provide clinical pharmacology assessments to due diligence and licensing evaluations, as applicable.
- Oversee clinical pharmacology CRO and modeling vendor relationships and deliverables.
- Perform other duties and responsibilities as assigned

**Qualifications:**

- Education: PharmD, PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, pharmaceutical sicences, or related discipline required.
- 10+ years of clinical pharmacology experience in pharma/biotech, including leadership of PK/PD strategy across development-stage programs.
- 3+ years of vendor management oversight experience with ability to manage and hold CRO/modeling vendors accountable for deliverable quality.
- Experience in immunology, inflammation, autoimmune disease, immune-mediated diseases, T-cell biology, cell therapy, biologics, gene therapy, or other novel therapeutic modalities preferred
- Expertise in population PK/PD modeling, , and relevant software (e.g., NONMEM, R).
- Strong knowledge of ICH and FDA/EMA clinical pharmacology guidance.
- Understanding of drug-drug interaction and special population study design.
- Proven ability to lead clinical pharmacology strategy discussions with senior internal and external stakeholders, including regulators.
- Excellent scientific writing and presentation skills for regulatory submissions and health authority interactions.
- Skilled at defending clinical pharmacology strategy directly with health authorities.
- Demonstrated ability to manage external CROs/vendors and coordinate study execution across multiple stakeholders
- Strong project/program management capability, including timeline planning, cross-functional coordination, risk tracking, deliverable management, and issue escalation.
- Ability to communicate scientific and operational issues clearly to cross-functional teams and senior stakeholders.

**Salary Range:**

The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

Salary Range

$266,000 - $344,000 USD

**Benefits:**

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

- Competitive health and wellness coverage (structure and premiums vary by country)
- Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
- Flexible work arrangements / hybrid schedule

*Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.*

**Equal Employment Opportunity:**

*Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.*

**Reasonable Accommodation:**

If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.

**Privacy**

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at [Privacy Policy - Beeline Medicines](<https://beelinemedicines.com/privacy-policy/>)

Massachusetts

Medical Science Liaison / Senior Medical Science Liaison - Japan

**About Beeline Medicines:**

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

**Job Summary:**

We are seeking talented field-based scientific professionals to join our Medical Affairs team as a Medical Science Liaison (MSL) or Senior Medical Science Liaison (Senior MSL) within our Immunology & Inflammation (I&I) therapeutic area. Both roles are central to building scientific awareness and advocacy for Beeline's pipeline, supporting investigator-initiated research, and facilitating meaningful peer-to-peer scientific exchange. The MSL level focuses on building foundational field excellence with progressive independence, while the Senior MSL operates with full strategic autonomy, leads senior KOL relationships, and contributes directly to Medical Affairs strategy and team development.

**Work Arrangement & Location:**

**Field-Based -** This position is field-based, and the incumbent will be expected to work within their assigned territory or region on behalf of the company. Regular travel within the designated geography is an inherent requirement of this role. Additional travel outside of the assigned territory may be required based on business need, including attendance at company meetings, training, or other organizational events.

**Territory Assignment Notice:**

Japan and other APAC countries as assigned.

Notice: The geographic territory outlined for this position reflects current business needs and is subject to change at the discretion of the organization. Territory boundaries, state assignments, and regional alignments may be modified at any time based on evolving business priorities, organizational restructuring, or strategic initiatives. The selected candidate will be expected to adapt to any such changes as a condition of employment.

**Medical Science Liaison Essential Duties and Responsibilities:**

- Contribute to development and refinement of medical strategy through field insights and HCP, KME, and investigator engagement.
- Develop and execute territory plans aligned with organizational priorities and data milestones.
- Develop and manage a defined territory of KME and HCP relationships within the I&I therapeutic area — identifying, mapping, and engaging scientific thought leaders, clinical investigators, and academic centers relevant to Beeline's pipeline under the direction of Medical Affairs leadership.
- Lead segmentation (Tier 1/2/3) development, strategic engagement plans and longitudinal relationship ownership with HCPs, KMEs, and investigators.
- Conduct peer-to-peer scientific exchange with KMEs, HCPs, and clinical investigators — sharing clinical and preclinical data, presenting pipeline updates, and discussing unmet medical needs in I&I in a balanced, compliant, and scientifically rigorous manner.
- Support clinical trial awareness and site identification efforts by engaging with potential investigators and academic institutions, facilitating scientific discussions that may support site initiation and patient enrollment for organization’s I&I programs. Serve as the key resource for scientific exchange as the ‘face of the sponsor’ with clinical site investigators from site start-up through end of study closeout in close collaboration with Clinical Operations.
- Respond to unsolicited medical information requests from HCPs, KMEs, and/or investigators in a timely, accurate, and compliant manner — in partnership with Medical Information and in accordance with applicable regulatory and compliance guidelines.
- Serve as the field-based scientific resource for HCP, KME and investigator interactions related to investigator-initiated studies (IIS) — supporting the IIS process by facilitating scientific discussions and coordinating with internal Medical Affairs leadership.
- Support identification of evidence gaps and contribute to evidence generation strategies.
- Generate, synthesize, and translate insights into strategic recommendations, with a focus on quality and actionability — including KME perspectives, competitive intelligence, clinical practice trends, and unmet need observations — back to Medical Affairs, Clinical Development, and other cross functional teams in a structured and timely manner.
- Represent Beeline at scientific conferences, medical congresses, and advisory board meetings within the I&I therapeutic area — engaging with scientific thought leaders and gathering data that informs the organization's medical and pipeline strategy.
- Perform other duties and responsibilities as assigned.

**Qualifications:**

- Education: Advanced degree required — PharmD, PhD, or MD in a relevant life sciences, pharmacy, or biomedical field. Post-doctoral training, clinical fellowship, or residency in a relevant discipline strongly preferred.
- Minimum of 3 years of MSL or related field-based medical affairs experience in the pharmaceutical or biotech industry, with experience in immunology, inflammation, or a related therapeutic area strongly preferred.
- Clinical-stage biotech experience a plus.
- Developing scientific and clinical knowledge of immunology and inflammation — demonstrates foundational understanding of disease mechanisms, treatment landscapes, and emerging therapeutic approaches and is actively building depth through ongoing learning.
- Ability to interpret and communicate clinical and scientific data — including study design, statistical concepts, and benefit-risk assessment — in peer-to-peer HCP KME, and investigator settings, with continued development of sophistication over time.
- Working proficiency in CRM platforms (e.g., Veeva) for field activity documentation, HCP, KME, and investigator mapping, and territory management — developing consistent documentation habits that reflect compliance and organizational standards.
- Building knowledge of medical affairs compliance frameworks — including FDA and EMA regulations, PhRMA guidelines, and the distinctions between on-label and off-label scientific exchange — with active demonstration of compliant field behavior in all interactions.
- Developing field independence — operates with guidance from Medical Affairs leadership, demonstrates growing ability to manage territory priorities, plan engagement calendars, and execute field activities with increasing self-direction.
- Team contributor and active learner — engages constructively in MSL team discussions, shares field observations openly, and demonstrates intellectual curiosity and a growth mindset in building scientific and professional capabilities.
- Developing scientific communication skills — able to present and discuss Beeline's I&I data clearly and accurately with HCPs, KMEs and investigators, with active development of the depth, nuance, and adaptability that characterizes expert-level scientific dialogue.
- Building active listening and field intelligence skills — demonstrates growing ability to capture insights and clinical practice observations accurately and translate them into concise, useful internal communications.
- Growing confidence in varied engagement settings — developing effectiveness in one-on-one HCP/KME/investigator meetings, small group scientific discussions, and conference interactions, with continued development toward advisory board and large group facilitation.
- Professional fluency in English (written and verbal) required
- Ability to safely and successfully operate a motor vehicle is required. Valid Driver’s License and a driving record in compliance with company standards
- Position may require ability to travel 50%+ as needed of time or more including occasional overnight stay driven by business need.
- Must be able to work evenings and weekends, as needed, for physician or patient events (both in person and virtual).
- Depending on geography, must have the ability to manage a multi-state territory with diverse customer base.

**Senior Medical Science Liaison Essential Duties and Responsibilities:**

- Lead and manage a strategically defined territory of senior KOL, clinical investigator, and academic center relationships — developing long-term, individualized engagement plans that align KOL scientific interests with organizations pipeline priorities and medical affairs objectives with full independence. Develop and continuously refine territory strategy based on evolving data milestones, KME influence mapping, and clinical development priorities; ensuring optimal allocation of time and resources to maximize impact.
- Conduct sophisticated, peer-to-peer scientific exchange with senior thought leaders, clinical investigators, and HCPs — including discussions of emerging clinical data, nuanced benefit-risk considerations, and evolving disease paradigms relevant to organization's I&I programs.
- Serve as a senior field resource for clinical trial support — including investigator identification, scientific site engagement, and contributions to enrollment strategy discussions in close collaboration with Clinical Development and Clinical Operations.
- Own and manage investigator-initiated study (IIS) relationships within the territory — serving as the primary scientific point of contact for investigators, facilitating the IIS review process, and maintaining ongoing scientific engagement with funded IIS sites.
- Proactively synthesize and present strategic KOL engagement insights and field intelligence — delivering actionable recommendations to Medical Affairs leadership, Clinical Development, and other strategy teams that influence organizational decision-making. Demonstrate measurable impact on key Medical Affairs priorities, including KME engagement quality, contribution to clinical trial enrollment and site activation, and influence on strategic decision-making through actionable field insights.
- Contribute to the development of MSL scientific training materials, field tools, and disease area resources — applying territorial expertise and scientific depth to strengthen the broader MSL team's capabilities and field effectiveness.
- Represent Beeline at major national and international scientific conferences, advisory boards, and KOL forums within I&I — serving as a senior scientific ambassador with the credibility and confidence to engage the field's most influential voices. Play a leadership role in advisory board development and execution; including KME identification, scientific input into agenda design, and synthesis of outcomes into strategic recommendations.
- Perform other duties and responsibilities as assigned.

**Qualifications:**

- Education: Advanced degree required — PharmD, PhD, or MD in a relevant life sciences, pharmacy, or biomedical field. Post-doctoral training, clinical fellowship, or residency in a relevant discipline strongly preferred.
- Minimum of 5 years of MSL or field-based medical affairs experience in the pharmaceutical or biotech industry, with demonstrated expertise in immunology, inflammation, or a closely related therapeutic area preferred.
- Prior involvement in IIS management or clinical trial support activities preferred.
- Clinical-stage biotech experience a plus
- Advanced scientific and clinical expertise in immunology and inflammation — demonstrates deep, current knowledge of disease biology, treatment algorithms, clinical trial endpoints, emerging mechanisms, and the competitive I&I landscape, applied with confidence in complex scientific discussions.
- Expert ability to interpret, contextualize, and communicate complex clinical and translational data — including study design nuances, subgroup analyses, and evolving safety/efficacy profiles — in substantive peer-level discussions with senior KOLs and investigators.
- Established proficiency in Veeva CRM and medical affairs field tools; experience with digital engagement platforms and virtual scientific exchange, with consistent documentation quality that reflects field excellence standards.
- Leverage AI-driven and omnichannel engagement strategies to complement in-person interactions; optimizing reach, frequency, and scientific exchange effectiveness with key stakeholders.
- Deep working knowledge of medical affairs compliance — including PhRMA guidelines, FDA regulations, and IIS management frameworks — demonstrated through a sustained record of compliant, high-quality field interactions and the ability to guide junior colleagues on compliance questions.
- Operates with full strategic independence — manages territory, KOL engagement plans, and field priorities without day-to-day guidance; proactively identifies opportunities and addresses challenges with sound judgment and organizational awareness.
- Highly sophisticated scientific communicator — engages senior KOLs, principal investigators, and academic thought leaders in nuanced, data-rich scientific dialogue that builds long-term credibility and trust for Beeline's I&I platform.
- Skilled at synthesizing and presenting complex field intelligence in structured, executive-ready internal communications — delivers strategic actionable recommendations and tracking downstream impact to refine engagement strategy and maximize organizational value to Medical Affairs and clinical leadership with clarity and confidence.
- Experienced facilitator and presenter — equally effective in one-on-one KOL settings, investigator meetings, advisory board participation, and large medical congress environments, with a demonstrated ability to adapt scientific communication style to audience needs.
- Professional fluency in English (written and verbal) required
- Ability to safely and successfully operate a motor vehicle is required. Valid Driver’s License and a driving record in compliance with company standards
- Position may require ability to travel 50%+ as needed of time or more including occasional overnight stay driven by business need.
- Must be able to work evenings and weekends, as needed, for physician or patient events (both in person and virtual).
- Depending on geography, must have the ability to manage a multi-state territory with diverse customer base.

**Benefits:**

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

- Competitive health and wellness coverage (structure and premiums vary by country)
- Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
- Flexible work arrangements / hybrid schedule

*Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.*

**Equal Employment Opportunity:**

*Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.*

**Reasonable Accommodation:**

If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.

**Privacy**

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at [Privacy Policy - Beeline Medicines](<https://beelinemedicines.com/privacy-policy/>)

Senior Medical Director, Medical Affairs

**About Beeline Medicines:**

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

**Job Summary:**

The Senior Medical Director, Medical Affairs is a senior therapeutic and disease area expert who serves as the organization's primary external medical and scientific resource for healthcare providers (HCPs), key medical experts (KMEs), clinical investigators, healthcare plans, hospital formulary decision-makers, and patient advocacy organizations. This role operates at the intersection of scientific leadership and external engagement — building and sustaining trusted peer-level relationships within the I&I community while driving the development and execution of the organization's medical affairs strategy most notably for the Beeline Medicines lead program; an investigational selective, oral, once-daily TLR7/8 inhibitor advancing into pivotal development for systemic and cutaneous lupus erythematosus — and for the broader I&I portfolio. The Senior Medical Director leads scientific exchange, supports evidence generation, shapes medical education and KME engagement programs, and serves as a senior internal scientific authority — providing medical input to clinical development, commercial readiness, market access, and regulatory strategy. The Senior Medical Director also serves as a medical reviewer and signatory on the promotional and medical review (MLR) committee for all externally facing company materials for health care professionals, advocacy groups and allied health care functions globally, ensuring factual accuracy and compliance with industry codes of conduct and regulations Reporting to the SVP of Clinical Development and Medical Affairs, this individual brings deep scientific expertise in autoimmune disease, demonstrated KME relationship management, and the strategic leadership presence required to drive the medical affairs function forward in a clinical-stage, resource-efficient biotech environment.

**Work Arrangement & Location:**

**Hybrid -** This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as **Tuesday and Wednesday**. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

**Essential Duties and Responsibilities:**

- Serve as the primary medical and scientific point of contact for KMEs, clinical investigators, HCPs, healthcare plan decision-makers, and patient advocacy groups within the I&I therapeutic area — with a primary focus on lupus (SLE and CLE) across rheumatology, dermatology, and nephrology — building and sustaining trusted, peer-level relationships that advance the organization's scientific and medical objectives. The Senior Medical Director may also support other therapeutic areas as required.
- Define and lead the execution of the medical affairs strategy for the I&I pipeline, including lupus indications — encompassing KME engagement, evidence generation, medical education, advisory board programming, and publication strategy — in alignment with clinical development milestones and corporate goals.
- Lead and conduct peer-to-peer scientific exchange with KMEs, investigators, and HCPs — sharing clinical and emerging data, discussing unmet medical needs, and gathering external insights that inform medical strategy, pipeline positioning, and commercial readiness.
- Monitor and critically assess competitive clinical data and emerging mechanisms to inform differentiation and scientific positioning.
- Partner with Scientific Communications to develop and maintain the core scientific narrative, medical communications platform, and scientific lexicon; including unbranded disease-state and mechanism-of-action education to build external scientific understanding of a novel target ahead of pivotal readouts.
- Lead the design and execution of medical advisory board meetings — identifying and engaging the right scientific experts, developing scientifically rigorous agendas, and ensuring that advisory board insights translate into actionable medical and strategic recommendations.
- Oversee the development and review of medical content — including medical education materials, scientific slide decks, congress abstracts, posters, and manuscripts — ensuring scientific accuracy, regulatory compliance, and strategic alignment across all external communications.
- Partner with Scientific Communications to develop and execute data disclosure and publication plans as executed in accordance with GPP 2022 and ICMJE authorship criteria.
- Lead scientific engagement strategy for major rheumatology congresses, including KME interactions, data communication planning, and insight capture.
- Provide Medical Affairs support for clinical programs, including investigator and site identification, feasibility input, engagement of steering committee members and national coordinating investigators, scientific input to protocol design, and site-facing scientific training in partnership with Clinical Development and Clinical Operations.
- Partner with Field Medical Affairs and MSL teams to ensure accurate, balanced, and up-to-date scientific tools and resources are available and consistently applied in field engagements — participating directly in key field interactions when the scientific complexity or stakeholder importance warrants senior medical presence.
- Provide strategic medical input into data generation initiatives including interventional (phase 3b, 4) and non-interventional trial design (real world evidence approaches, registry studies) to support market authorization of the asset and life cycle management.
- Collaborate with Clinical Development, Biostatistics, Regulatory Affairs, and other departments on the medical interpretation of clinical data, regulatory submissions, payer engagement strategies, and commercial launch planning — serving as a medical affairs voice across all key cross-functional initiatives.
- Perform other duties and responsibilities as assigned

**Qualifications:**

- Education: Advanced clinical degree (MD or DO) required. Board certification or clinical training in rheumatology, dermatology, nephrology, immunology, or a related specialty strongly preferred. Additional advanced degree (PhD, MPH, or MBA) is a plus.
- Minimum of 5 years clinical and 5 years pharmaceutical/biotech industry experience in medical affairs inclusive of supporting product launches preferred
- Direct experience managing or advising lupus clinical programs strongly preferred.
- Deep scientific expertise in autoimmune disease — specifically lupus (SLE and/or CLE), rheumatology, and/or nephrology — required.
- Established KME network within the lupus, rheumatology, and dermatology communities strongly preferred.
- Experience supporting a registrational or pivotal program through pre-launch medical affairs readiness — including major congress data disclosure, field medical build-out, and compliant pre-approval payer engagement — strongly preferred.
- Deep clinical and scientific expertise in immunology and inflammation — with primary depth in lupus nephritis, SLE, and/or CLE — including command of disease mechanisms, clinical trial landscapes, standard of care evolution, regulatory developments, and emerging therapeutic approaches.
- Demonstrated ability to critically evaluate, synthesize, and communicate complex clinical and scientific literature — including clinical trial data, real-world evidence, and regulatory data packages — to diverse internal and external audiences.
- Experience supporting regulatory submissions, label negotiations, or advisory committee preparations from a medical affairs perspective; familiarity with promotional review processes and compliance frameworks governing medical communications.
- Working command of the compliance framework governing pre-approval scientific exchange — medical–commercial separation, non-promotional communication standards, reactive-only handling of unapproved-use inquiries, the PhRMA Code, FDA OPDP guidance, and applicable EFPIA/ABPI codes — together with transparency obligations including Open Payments reporting of transfers of value.
- Prior experience with advisory board design, scientific meeting planning, ISR program oversight, HEOR strategy, and external expert relationship management in a pharmaceutical or biotech medical affairs context.
- Senior medical affairs leader with demonstrated ability to define and execute medical strategy, lead cross-functional medical initiatives, and operate with significant independence in a lean, clinical-stage biotech environment.
- Proven external relationship leader — builds and sustains trusted, long-term relationships with national and regional KMEs, clinical investigators, and patient advocacy organizations through scientific credibility, consistent follow-through, and genuine commitment to advancing medical knowledge.
- Influential cross-functional partner — drives alignment across Medical Affairs, Clinical Development, Regulatory, Commercial, and Market Access through strong scientific authority and the ability to translate medical insights into organizational action via clear, prioritized medical actions and strategic recommendations.
- Exceptional scientific and medical communicator — engages KMEs, investigators, HCPs, payers, and patient advocacy leaders in substantive, peer-level scientific dialogue with depth, balance, and clarity appropriate to each audience.
- Skilled presenter and medical content developer — prepares and delivers compelling presentations, advisory board materials, and scientific updates to external experts, cross-functional leadership, and executive audiences with precision and strategic framing.
- Strong active listener and external insights integrator — synthesizes KME perspectives, clinical practice trends, and competitive intelligence into actionable medical strategy recommendations that inform organizational decision-making.
- Position may require ability to travel 30%+ as needed of time or more including occasional overnight stay driven by business need
- Relocation available

**Salary Range:**

The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

Salary Range

$293,000 - $345,000 USD

**Benefits:**

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

- Competitive health and wellness coverage (structure and premiums vary by country)
- Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
- Flexible work arrangements / hybrid schedule

*Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.*

**Equal Employment Opportunity:**

*Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.*

**Reasonable Accommodation:**

If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.

**Privacy**

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at [Privacy Policy - Beeline Medicines](<https://beelinemedicines.com/privacy-policy/>)

Global Pharmacovigilance Senior Medical Director

**About Beeline Medicines:**

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

**Job Summary:**

The Global Pharmacovigilance Senior Medical Director is the company's senior physician-level for drug safety, providing enterprise-wide medical and scientific leadership across all pharmacovigilance activities supporting the immunology and inflammation (I&I) pipeline, including the company's lead lupus program. As the principal physician for benefit-risk evaluation, signal assessment, and safety governance on specific program. This is a senior individual-expert role that leads through scientific insights and cross-functional influence: the Senior Director acts as company's primary physician representative to Health Authorities, Data Safety Monitoring Boards, and external advisory bodies for specific program(s) as needed. The Senior Director partners closely with Clinical Development, Regulatory Affairs, Medical Affairs, and Program Leadership to deliver medically sound, strategically aligned safety leadership at a critical stage of the company's growth.

**Work Arrangement & Location:**

**Remote -** This position is designated as remote; the incumbent will be expected to travel to Beeline Medicines’ offices on a periodic basis to support in-person collaboration, team engagement, and business operations. The frequency and scheduling of such visits will be determined at the company's discretion based on business need.

**Essential Duties and Responsibilities:**

- Serve as the company's senior physician for safety science and pharmacovigilance, setting the medical standard for medical judgment on individual case safety reports (ICSRs), aggregate safety analyses, signal evaluations, and benefit-risk assessments across the I&I portfolio.
- Set the strategy and quality standards for medical review and clinical interpretation of safety data arising from clinical trials, spontaneous reports, literature, and real-world sources, and provide medical oversight of the PV vendor's safety evaluation output to ensure timely, accurate, and scientifically rigorous assessment of all pharmacovigilance data.
- Serve as the accountable medical authority for benefit-risk evaluations underpinning regulatory submissions, label negotiations, and Health Authority safety communications.
- Serve as senior medical lead to Clinical Development on Data Safety Monitoring Board (DSMB) strategy and interactions, clinical trial safety monitoring plans, safety risk mitigation strategy (e.g., stopping rules), and protocol-level safety sections for all active and planned studies.
- Direct the medical strategy for Risk Management Plans and safety-relevant regulatory documents across the full development lifecycle, including the design, execution, and effectiveness assessment of risk minimization measures.
- Provide medical leadership, scientific mentorship, and technical development to the Pharmacovigilance team, PV vendor personnel, and partner functions (e.g., Medical Writing, Clinical Operations), establishing a culture of medical excellence and patient-first decision-making.
- Provide senior medical oversight of emerging safety data and lead the safety-side response to emergent issues in collaboration with Medical Affairs and Regulatory Affairs.
- Serve as the safety lead for evaluation of target compound safety profiles, integrated benefit-risk assessment, and PV infrastructure readiness.
- Shape the strategy for integrating real-world safety evidence (including Epi work) records into the company's signal detection and benefit-risk evaluation framework.
- Perform other duties and responsibilities as assigned

**Qualifications:**

- Education: Medical degree (MD or DO) required; board certification in immunology, rheumatology, internal medicine, or a related specialty, with clinical experience in autoimmune disease, is strongly preferred
- Minimum of 10+ years of combined clinical and pharmaceutical/biotech industry experience, with at least 8–10 years of dedicated pharmacovigilance or drug safety experience in a senior medical role, including prior experience at Director level or equivalent. I&I experience preferred.
- Extensive track record serving as physician-of-record for pharmacovigilance programs across multiple compounds or indications, including ICSR medical review, signal evaluation, benefit-risk assessment, and aggregate safety reporting.
- Authoritative knowledge of global safety and pharmacovigilance regulations, including FDA guidance, EU GVP Modules I–XVI, and ICH guidelines, with proven ability to interpret and apply them to novel or ambiguous situations
- Demonstrated medical leadership of safety surveillance planning, benefit-risk assessment, and safety content for IND and NDA/BLA submissions, including direct authorship or final medical approval of complex safety narratives and integrated summaries of safety.
- Experience owning or leading Risk Management Plans (RMPs) and REMS programs, including development of risk minimization measures and assessment of their effectiveness.
- Deep knowledge of biologics safety considerations specific to immunology indications, including infection risk, immunosuppression, immunogenicity, and organ-specific toxicity in the autoimmune disease population.
- Prior experience in an early- or mid-stage biotech environment with responsibility for building or shaping a pharmacovigilance function, and for providing medical oversight of outsourced PV service providers, is highly desirable..
- Exceptional written and verbal communication skills with demonstrated ability to translate complex scientific, regulatory, or operational content for diverse audiences, including executive leadership, clinical teams, and external partners.
- Skilled at preparing and delivering compelling presentations, briefing documents and regulatory responses, and strategic safety updates to executive leadership, board-level stakeholders, and external advisory bodies.
- Strong active listening skills and the ability to synthesize input from diverse perspectives into clear, actionable communications that build alignment and drive decision-making.

**Salary Range:**

The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

Salary Range

$320,000 - $400,000 USD

**Benefits:**

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

- Competitive health and wellness coverage (structure and premiums vary by country)
- Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
- Flexible work arrangements / hybrid schedule

*Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.*

**Equal Employment Opportunity:**

*Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.*

**Reasonable Accommodation:**

If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.

**Privacy**

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at [Privacy Policy - Beeline Medicines](<https://beelinemedicines.com/privacy-policy/>)

Director, Medical Writing

**About Beeline Medicines:**

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

**Job Summary:**

The Director, Medical Writing is a hands-on leadership role responsible for clear scientific messaging and for the development, coordination, and delivery of high-quality regulatory, nonclinical, clinical, and other scientific documents in support of the company's I&I pipeline. This position combines active document authorship with functional leadership of medical writing, ensuring that deliverables meet high standards of scientific accuracy, regulatory compliance, and clarity.

The Director owns the design and implementation of medical writing processes, templates, and standards, builds and manages internal writing capability, and directs the selection, oversight, and performance of external writing vendors within an agreed budget. The role partners closely with Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs, and external vendors to plan, author, review, and deliver documents supporting critical regulatory milestones, including INDs, amendments, briefing packages, and selected NDA/BLA components.

This role is expected to remain closely involved in the hands-on execution of core documents while carrying accountability for people management, vendor and budget management, and delivery across multiple concurrent programs as submission activity expands.

**Work Arrangement & Location:**

**Remote -** This position is designated as remote; the incumbent will be expected to travel to Beeline Medicines’ offices on a periodic basis to support in-person collaboration, team engagement, and business operations. The frequency and scheduling of such visits will be determined at the company's discretion based on business need.

**Essential Duties and Responsibilities:**

- Own day to day execution of medical writing activities, authoring, coordinating, and reviewing key clinical and regulatory documents, including protocols and amendments, CSRs, IBs, SAPs, ICFs, INDs/CTAs, and selected BLA/NDA components, ensuring scientific accuracy, regulatory compliance, and consistency of content.
- Contribute to defining the strategy for submission narratives and key messages, leading scientific messaging consistency across CTD modules. Represent Medical Writing in cross functional and governance forums and drive alignment on submission strategy and document readiness.
- Direct planning and sequencing of document deliverables with Clinical Development, Nonclinical, Biostatistics, Safety, and Regulatory Affairs; own integrated timelines and trackers across concurrent programs, coordinate cross functional review cycles, anticipate and mitigate bottlenecks, and provide regular, transparent status updates to cross functional teams and leadership.
- Manage and develop medical writing staff and contract writers
- Manage medical writing vendors, including selection, scope definition, deliverable tracking, quality oversight, and performance review. Own the Medical Writing budget and forecast internal FTE and vendor capacity against the program plan.
- Establish, document, and maintain the process for authoring, review, QC, and approval of regulatory documents submitted to health authorities, including SOPs, style guides, and templates aligned with ICH and regional requirements. Develop and deliver training to the cross functional team to ensure adoption of the agreed process.
- Support Health Authority briefing documents, meeting request packages, and written responses to Agency queries.
- Manage the Medical Writing function budget and resource planning, including FTE capacity and vendor utilization forecasting.
- Perform other duties and responsibilities as assigned.

**Qualifications:**

- Education: Advanced degree (PhD, PharmD, or master's level) in life sciences, pharmacology, biomedical sciences, or a related discipline required.
- Minimum of 10+ years of medical writing experience in the pharmaceutical or biotech industry,
- Extensive experience authoring and overseeing regulatory submissions in ICH CTD format, including CSRs, ISS/ISE, IBs, and IND/CTA packages.
- Deep scientific expertise in immunology, inflammation, or autoimmune disease is preferred, with the ability to rapidly acquire technical knowledge in new therapeutic areas.
- Demonstrated ability to manage multiple concurrent document deliverables and writing teams in a high-priority regulatory environment.
- Thorough knowledge of FDA and EMA regulatory writing requirements, ICH E3, E6, E8, and M4 guidelines, and applicable pharmacovigilance documentation standards.
- Experience developing and enforcing Medical Writing SOPs, style guides, and document templates in a regulated pharmaceutical environment.
- Proficiency with document management systems, electronic submission tools, and publishing platforms such as Veeva Vault or equivalent.
- Strong publication planning experience, including familiarity with ICMJE authorship guidelines, journal submission processes, and scientific congress submission requirements.
- Proficiency with AI-assisted authoring and review tools applied to regulatory and clinical documents is strongly preferred, including practical understanding best prompt practices, limitations, quality control requirements, and appropriate use in a regulated environment.
- Experience building or scaling a Medical Writing function in an early-stage or rapidly growing biotech organization is highly desirable.
- Demonstrated ability to lead, mentor, and develop cross-functional teams in a fast-paced, resource-constrained biotech or pharmaceutical environment; fosters a culture of accountability, inclusion, and continuous learning.
- Proven track record of influencing without authority across organizational boundaries, driving alignment among senior stakeholders, and building consensus on complex scientific or operational priorities.
- Exceptional written and verbal communication skills with demonstrated ability to translate complex scientific, regulatory, or operational content for diverse audiences, including executive leadership, clinical teams, and external partners.
- Skilled at preparing and delivering compelling presentations, briefing documents, and strategic updates to cross-functional leadership teams and board-level stakeholders.

**Salary Range:**

The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

Salary Range

$199,000 - $258,000 USD

**Benefits:**

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

- Competitive health and wellness coverage (structure and premiums vary by country)
- Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
- Flexible work arrangements / hybrid schedule

*Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.*

**Equal Employment Opportunity:**

*Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.*

**Reasonable Accommodation:**

If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.

**Privacy**

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at [Privacy Policy - Beeline Medicines](<https://beelinemedicines.com/privacy-policy/>)

Medical Science Liaison / Senior Medical Science Liaison - China

**About Beeline Medicines:**

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

**Job Summary:**

We are seeking talented field-based scientific professionals to join our Medical Affairs team as a Medical Science Liaison (MSL) or Senior Medical Science Liaison (Senior MSL) within our Immunology & Inflammation (I&I) therapeutic area. Both roles are central to building scientific awareness and advocacy for Beeline's pipeline, supporting investigator-initiated research, and facilitating meaningful peer-to-peer scientific exchange. The MSL level focuses on building foundational field excellence with progressive independence, while the Senior MSL operates with full strategic autonomy, leads senior KOL relationships, and contributes directly to Medical Affairs strategy and team development.

**Work Arrangement & Location:**

**Field-Based -** This position is field-based, and the incumbent will be expected to work within their assigned territory or region on behalf of the company. Regular travel within the designated geography is an inherent requirement of this role. Additional travel outside of the assigned territory may be required based on business need, including attendance at company meetings, training, or other organizational events.

**Territory Assignment Notice:**

China and other APAC countries as assigned.

Notice: The geographic territory outlined for this position reflects current business needs and is subject to change at the discretion of the organization. Territory boundaries, state assignments, and regional alignments may be modified at any time based on evolving business priorities, organizational restructuring, or strategic initiatives. The selected candidate will be expected to adapt to any such changes as a condition of employment.

**Medical Science Liaison Essential Duties and Responsibilities:**

- Contribute to development and refinement of medical strategy through field insights and HCP, KME, and investigator engagement.
- Develop and execute territory plans aligned with organizational priorities and data milestones.
- Develop and manage a defined territory of KME and HCP relationships within the I&I therapeutic area — identifying, mapping, and engaging scientific thought leaders, clinical investigators, and academic centers relevant to Beeline's pipeline under the direction of Medical Affairs leadership.
- Lead segmentation (Tier 1/2/3) development, strategic engagement plans and longitudinal relationship ownership with HCPs, KMEs, and investigators.
- Conduct peer-to-peer scientific exchange with KMEs, HCPs, and clinical investigators — sharing clinical and preclinical data, presenting pipeline updates, and discussing unmet medical needs in I&I in a balanced, compliant, and scientifically rigorous manner.
- Support clinical trial awareness and site identification efforts by engaging with potential investigators and academic institutions, facilitating scientific discussions that may support site initiation and patient enrollment for organization’s I&I programs. Serve as the key resource for scientific exchange as the ‘face of the sponsor’ with clinical site investigators from site start-up through end of study closeout in close collaboration with Clinical Operations.
- Respond to unsolicited medical information requests from HCPs, KMEs, and/or investigators in a timely, accurate, and compliant manner — in partnership with Medical Information and in accordance with applicable regulatory and compliance guidelines.
- Serve as the field-based scientific resource for HCP, KME and investigator interactions related to investigator-initiated studies (IIS) — supporting the IIS process by facilitating scientific discussions and coordinating with internal Medical Affairs leadership.
- Support identification of evidence gaps and contribute to evidence generation strategies.
- Generate, synthesize, and translate insights into strategic recommendations, with a focus on quality and actionability — including KME perspectives, competitive intelligence, clinical practice trends, and unmet need observations — back to Medical Affairs, Clinical Development, and other cross functional teams in a structured and timely manner.
- Represent Beeline at scientific conferences, medical congresses, and advisory board meetings within the I&I therapeutic area — engaging with scientific thought leaders and gathering data that informs the organization's medical and pipeline strategy.
- Perform other duties and responsibilities as assigned.

**Qualifications:**

- Education: Advanced degree required — PharmD, PhD, or MD in a relevant life sciences, pharmacy, or biomedical field. Post-doctoral training, clinical fellowship, or residency in a relevant discipline strongly preferred.
- Minimum of 3 years of MSL or related field-based medical affairs experience in the pharmaceutical or biotech industry, with experience in immunology, inflammation, or a related therapeutic area strongly preferred.
- Clinical-stage biotech experience a plus.
- Developing scientific and clinical knowledge of immunology and inflammation — demonstrates foundational understanding of disease mechanisms, treatment landscapes, and emerging therapeutic approaches and is actively building depth through ongoing learning.
- Ability to interpret and communicate clinical and scientific data — including study design, statistical concepts, and benefit-risk assessment — in peer-to-peer HCP KME, and investigator settings, with continued development of sophistication over time.
- Working proficiency in CRM platforms (e.g., Veeva) for field activity documentation, HCP, KME, and investigator mapping, and territory management — developing consistent documentation habits that reflect compliance and organizational standards.
- Building knowledge of medical affairs compliance frameworks — including FDA and EMA regulations, PhRMA guidelines, and the distinctions between on-label and off-label scientific exchange — with active demonstration of compliant field behavior in all interactions.
- Developing field independence — operates with guidance from Medical Affairs leadership, demonstrates growing ability to manage territory priorities, plan engagement calendars, and execute field activities with increasing self-direction.
- Team contributor and active learner — engages constructively in MSL team discussions, shares field observations openly, and demonstrates intellectual curiosity and a growth mindset in building scientific and professional capabilities.
- Developing scientific communication skills — able to present and discuss Beeline's I&I data clearly and accurately with HCPs, KMEs and investigators, with active development of the depth, nuance, and adaptability that characterizes expert-level scientific dialogue.
- Building active listening and field intelligence skills — demonstrates growing ability to capture insights and clinical practice observations accurately and translate them into concise, useful internal communications.
- Growing confidence in varied engagement settings — developing effectiveness in one-on-one HCP/KME/investigator meetings, small group scientific discussions, and conference interactions, with continued development toward advisory board and large group facilitation.
- Professional fluency in English (written and verbal) required
- Ability to safely and successfully operate a motor vehicle is required. Valid Driver’s License and a driving record in compliance with company standards
- Position may require ability to travel 50%+ as needed of time or more including occasional overnight stay driven by business need.
- Must be able to work evenings and weekends, as needed, for physician or patient events (both in person and virtual).
- Depending on geography, must have the ability to manage a multi-state territory with diverse customer base.

**Senior Medical Science Liaison Essential Duties and Responsibilities:**

- Lead and manage a strategically defined territory of senior KOL, clinical investigator, and academic center relationships — developing long-term, individualized engagement plans that align KOL scientific interests with organizations pipeline priorities and medical affairs objectives with full independence. Develop and continuously refine territory strategy based on evolving data milestones, KME influence mapping, and clinical development priorities; ensuring optimal allocation of time and resources to maximize impact.
- Conduct sophisticated, peer-to-peer scientific exchange with senior thought leaders, clinical investigators, and HCPs — including discussions of emerging clinical data, nuanced benefit-risk considerations, and evolving disease paradigms relevant to organization's I&I programs.
- Serve as a senior field resource for clinical trial support — including investigator identification, scientific site engagement, and contributions to enrollment strategy discussions in close collaboration with Clinical Development and Clinical Operations.
- Own and manage investigator-initiated study (IIS) relationships within the territory — serving as the primary scientific point of contact for investigators, facilitating the IIS review process, and maintaining ongoing scientific engagement with funded IIS sites.
- Proactively synthesize and present strategic KOL engagement insights and field intelligence — delivering actionable recommendations to Medical Affairs leadership, Clinical Development, and other strategy teams that influence organizational decision-making. Demonstrate measurable impact on key Medical Affairs priorities, including KME engagement quality, contribution to clinical trial enrollment and site activation, and influence on strategic decision-making through actionable field insights.
- Contribute to the development of MSL scientific training materials, field tools, and disease area resources — applying territorial expertise and scientific depth to strengthen the broader MSL team's capabilities and field effectiveness.
- Represent Beeline at major national and international scientific conferences, advisory boards, and KOL forums within I&I — serving as a senior scientific ambassador with the credibility and confidence to engage the field's most influential voices. Play a leadership role in advisory board development and execution; including KME identification, scientific input into agenda design, and synthesis of outcomes into strategic recommendations.
- Perform other duties and responsibilities as assigned.

**Qualifications:**

- Education: Advanced degree required — PharmD, PhD, or MD in a relevant life sciences, pharmacy, or biomedical field. Post-doctoral training, clinical fellowship, or residency in a relevant discipline strongly preferred.
- Minimum of 5 years of MSL or field-based medical affairs experience in the pharmaceutical or biotech industry, with demonstrated expertise in immunology, inflammation, or a closely related therapeutic area preferred.
- Prior involvement in IIS management or clinical trial support activities preferred.
- Clinical-stage biotech experience a plus
- Advanced scientific and clinical expertise in immunology and inflammation — demonstrates deep, current knowledge of disease biology, treatment algorithms, clinical trial endpoints, emerging mechanisms, and the competitive I&I landscape, applied with confidence in complex scientific discussions.
- Expert ability to interpret, contextualize, and communicate complex clinical and translational data — including study design nuances, subgroup analyses, and evolving safety/efficacy profiles — in substantive peer-level discussions with senior KOLs and investigators.
- Established proficiency in Veeva CRM and medical affairs field tools; experience with digital engagement platforms and virtual scientific exchange, with consistent documentation quality that reflects field excellence standards.
- Leverage AI-driven and omnichannel engagement strategies to complement in-person interactions; optimizing reach, frequency, and scientific exchange effectiveness with key stakeholders.
- Deep working knowledge of medical affairs compliance — including PhRMA guidelines, FDA regulations, and IIS management frameworks — demonstrated through a sustained record of compliant, high-quality field interactions and the ability to guide junior colleagues on compliance questions.
- Operates with full strategic independence — manages territory, KOL engagement plans, and field priorities without day-to-day guidance; proactively identifies opportunities and addresses challenges with sound judgment and organizational awareness.
- Highly sophisticated scientific communicator — engages senior KOLs, principal investigators, and academic thought leaders in nuanced, data-rich scientific dialogue that builds long-term credibility and trust for Beeline's I&I platform.
- Skilled at synthesizing and presenting complex field intelligence in structured, executive-ready internal communications — delivers strategic actionable recommendations and tracking downstream impact to refine engagement strategy and maximize organizational value to Medical Affairs and clinical leadership with clarity and confidence.
- Experienced facilitator and presenter — equally effective in one-on-one KOL settings, investigator meetings, advisory board participation, and large medical congress environments, with a demonstrated ability to adapt scientific communication style to audience needs.
- Professional fluency in English (written and verbal) required
- Ability to safely and successfully operate a motor vehicle is required. Valid Driver’s License and a driving record in compliance with company standards
- Position may require ability to travel 50%+ as needed of time or more including occasional overnight stay driven by business need.
- Must be able to work evenings and weekends, as needed, for physician or patient events (both in person and virtual).
- Depending on geography, must have the ability to manage a multi-state territory with diverse customer base.

**Benefits:**

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

- Competitive health and wellness coverage (structure and premiums vary by country)
- Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
- Flexible work arrangements / hybrid schedule

*Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.*

**Equal Employment Opportunity:**

*Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.*

**Reasonable Accommodation:**

If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.

**Privacy**

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at [Privacy Policy - Beeline Medicines](<https://beelinemedicines.com/privacy-policy/>)

Medical Science Liaison / Senior Medical Science Liaison - India

**About Beeline Medicines:**

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

**Job Summary:**

We are seeking talented field-based scientific professionals to join our Medical Affairs team as a Medical Science Liaison (MSL) or Senior Medical Science Liaison (Senior MSL) within our Immunology & Inflammation (I&I) therapeutic area. Both roles are central to building scientific awareness and advocacy for Beeline's pipeline, supporting investigator-initiated research, and facilitating meaningful peer-to-peer scientific exchange. The MSL level focuses on building foundational field excellence with progressive independence, while the Senior MSL operates with full strategic autonomy, leads senior KOL relationships, and contributes directly to Medical Affairs strategy and team development.

**Work Arrangement & Location:**

**Field-Based -** This position is field-based, and the incumbent will be expected to work within their assigned territory or region on behalf of the company. Regular travel within the designated geography is an inherent requirement of this role. Additional travel outside of the assigned territory may be required based on business need, including attendance at company meetings, training, or other organizational events.

**Territory Assignment Notice:**

India and other APAC countries as assigned.

Notice: The geographic territory outlined for this position reflects current business needs and is subject to change at the discretion of the organization. Territory boundaries, state assignments, and regional alignments may be modified at any time based on evolving business priorities, organizational restructuring, or strategic initiatives. The selected candidate will be expected to adapt to any such changes as a condition of employment.

**Medical Science Liaison Essential Duties and Responsibilities:**

- Contribute to development and refinement of medical strategy through field insights and HCP, KME, and investigator engagement.
- Develop and execute territory plans aligned with organizational priorities and data milestones.
- Develop and manage a defined territory of KME and HCP relationships within the I&I therapeutic area — identifying, mapping, and engaging scientific thought leaders, clinical investigators, and academic centers relevant to Beeline's pipeline under the direction of Medical Affairs leadership.
- Lead segmentation (Tier 1/2/3) development, strategic engagement plans and longitudinal relationship ownership with HCPs, KMEs, and investigators.
- Conduct peer-to-peer scientific exchange with KMEs, HCPs, and clinical investigators — sharing clinical and preclinical data, presenting pipeline updates, and discussing unmet medical needs in I&I in a balanced, compliant, and scientifically rigorous manner.
- Support clinical trial awareness and site identification efforts by engaging with potential investigators and academic institutions, facilitating scientific discussions that may support site initiation and patient enrollment for organization’s I&I programs. Serve as the key resource for scientific exchange as the ‘face of the sponsor’ with clinical site investigators from site start-up through end of study closeout in close collaboration with Clinical Operations.
- Respond to unsolicited medical information requests from HCPs, KMEs, and/or investigators in a timely, accurate, and compliant manner — in partnership with Medical Information and in accordance with applicable regulatory and compliance guidelines.
- Serve as the field-based scientific resource for HCP, KME and investigator interactions related to investigator-initiated studies (IIS) — supporting the IIS process by facilitating scientific discussions and coordinating with internal Medical Affairs leadership.
- Support identification of evidence gaps and contribute to evidence generation strategies.
- Generate, synthesize, and translate insights into strategic recommendations, with a focus on quality and actionability — including KME perspectives, competitive intelligence, clinical practice trends, and unmet need observations — back to Medical Affairs, Clinical Development, and other cross functional teams in a structured and timely manner.
- Represent Beeline at scientific conferences, medical congresses, and advisory board meetings within the I&I therapeutic area — engaging with scientific thought leaders and gathering data that informs the organization's medical and pipeline strategy.
- Perform other duties and responsibilities as assigned.

**Qualifications:**

- Education: Advanced degree required — PharmD, PhD, or MD in a relevant life sciences, pharmacy, or biomedical field. Post-doctoral training, clinical fellowship, or residency in a relevant discipline strongly preferred.
- Minimum of 3 years of MSL or related field-based medical affairs experience in the pharmaceutical or biotech industry, with experience in immunology, inflammation, or a related therapeutic area strongly preferred.
- Clinical-stage biotech experience a plus.
- Developing scientific and clinical knowledge of immunology and inflammation — demonstrates foundational understanding of disease mechanisms, treatment landscapes, and emerging therapeutic approaches and is actively building depth through ongoing learning.
- Ability to interpret and communicate clinical and scientific data — including study design, statistical concepts, and benefit-risk assessment — in peer-to-peer HCP KME, and investigator settings, with continued development of sophistication over time.
- Working proficiency in CRM platforms (e.g., Veeva) for field activity documentation, HCP, KME, and investigator mapping, and territory management — developing consistent documentation habits that reflect compliance and organizational standards.
- Building knowledge of medical affairs compliance frameworks — including FDA and EMA regulations, PhRMA guidelines, and the distinctions between on-label and off-label scientific exchange — with active demonstration of compliant field behavior in all interactions.
- Developing field independence — operates with guidance from Medical Affairs leadership, demonstrates growing ability to manage territory priorities, plan engagement calendars, and execute field activities with increasing self-direction.
- Team contributor and active learner — engages constructively in MSL team discussions, shares field observations openly, and demonstrates intellectual curiosity and a growth mindset in building scientific and professional capabilities.
- Developing scientific communication skills — able to present and discuss Beeline's I&I data clearly and accurately with HCPs, KMEs and investigators, with active development of the depth, nuance, and adaptability that characterizes expert-level scientific dialogue.
- Building active listening and field intelligence skills — demonstrates growing ability to capture insights and clinical practice observations accurately and translate them into concise, useful internal communications.
- Growing confidence in varied engagement settings — developing effectiveness in one-on-one HCP/KME/investigator meetings, small group scientific discussions, and conference interactions, with continued development toward advisory board and large group facilitation.
- Professional fluency in English (written and verbal) required
- Ability to safely and successfully operate a motor vehicle is required. Valid Driver’s License and a driving record in compliance with company standards
- Position may require ability to travel 50%+ as needed of time or more including occasional overnight stay driven by business need.
- Must be able to work evenings and weekends, as needed, for physician or patient events (both in person and virtual).
- Depending on geography, must have the ability to manage a multi-state territory with diverse customer base.

**Senior Medical Science Liaison Essential Duties and Responsibilities:**

- Lead and manage a strategically defined territory of senior KOL, clinical investigator, and academic center relationships — developing long-term, individualized engagement plans that align KOL scientific interests with organizations pipeline priorities and medical affairs objectives with full independence. Develop and continuously refine territory strategy based on evolving data milestones, KME influence mapping, and clinical development priorities; ensuring optimal allocation of time and resources to maximize impact.
- Conduct sophisticated, peer-to-peer scientific exchange with senior thought leaders, clinical investigators, and HCPs — including discussions of emerging clinical data, nuanced benefit-risk considerations, and evolving disease paradigms relevant to organization's I&I programs.
- Serve as a senior field resource for clinical trial support — including investigator identification, scientific site engagement, and contributions to enrollment strategy discussions in close collaboration with Clinical Development and Clinical Operations.
- Own and manage investigator-initiated study (IIS) relationships within the territory — serving as the primary scientific point of contact for investigators, facilitating the IIS review process, and maintaining ongoing scientific engagement with funded IIS sites.
- Proactively synthesize and present strategic KOL engagement insights and field intelligence — delivering actionable recommendations to Medical Affairs leadership, Clinical Development, and other strategy teams that influence organizational decision-making. Demonstrate measurable impact on key Medical Affairs priorities, including KME engagement quality, contribution to clinical trial enrollment and site activation, and influence on strategic decision-making through actionable field insights.
- Contribute to the development of MSL scientific training materials, field tools, and disease area resources — applying territorial expertise and scientific depth to strengthen the broader MSL team's capabilities and field effectiveness.
- Represent Beeline at major national and international scientific conferences, advisory boards, and KOL forums within I&I — serving as a senior scientific ambassador with the credibility and confidence to engage the field's most influential voices. Play a leadership role in advisory board development and execution; including KME identification, scientific input into agenda design, and synthesis of outcomes into strategic recommendations.
- Perform other duties and responsibilities as assigned.

**Qualifications:**

- Education: Advanced degree required — PharmD, PhD, or MD in a relevant life sciences, pharmacy, or biomedical field. Post-doctoral training, clinical fellowship, or residency in a relevant discipline strongly preferred.
- Minimum of 5 years of MSL or field-based medical affairs experience in the pharmaceutical or biotech industry, with demonstrated expertise in immunology, inflammation, or a closely related therapeutic area preferred.
- Prior involvement in IIS management or clinical trial support activities preferred.
- Clinical-stage biotech experience a plus
- Advanced scientific and clinical expertise in immunology and inflammation — demonstrates deep, current knowledge of disease biology, treatment algorithms, clinical trial endpoints, emerging mechanisms, and the competitive I&I landscape, applied with confidence in complex scientific discussions.
- Expert ability to interpret, contextualize, and communicate complex clinical and translational data — including study design nuances, subgroup analyses, and evolving safety/efficacy profiles — in substantive peer-level discussions with senior KOLs and investigators.
- Established proficiency in Veeva CRM and medical affairs field tools; experience with digital engagement platforms and virtual scientific exchange, with consistent documentation quality that reflects field excellence standards.
- Leverage AI-driven and omnichannel engagement strategies to complement in-person interactions; optimizing reach, frequency, and scientific exchange effectiveness with key stakeholders.
- Deep working knowledge of medical affairs compliance — including PhRMA guidelines, FDA regulations, and IIS management frameworks — demonstrated through a sustained record of compliant, high-quality field interactions and the ability to guide junior colleagues on compliance questions.
- Operates with full strategic independence — manages territory, KOL engagement plans, and field priorities without day-to-day guidance; proactively identifies opportunities and addresses challenges with sound judgment and organizational awareness.
- Highly sophisticated scientific communicator — engages senior KOLs, principal investigators, and academic thought leaders in nuanced, data-rich scientific dialogue that builds long-term credibility and trust for Beeline's I&I platform.
- Skilled at synthesizing and presenting complex field intelligence in structured, executive-ready internal communications — delivers strategic actionable recommendations and tracking downstream impact to refine engagement strategy and maximize organizational value to Medical Affairs and clinical leadership with clarity and confidence.
- Experienced facilitator and presenter — equally effective in one-on-one KOL settings, investigator meetings, advisory board participation, and large medical congress environments, with a demonstrated ability to adapt scientific communication style to audience needs.
- Professional fluency in English (written and verbal) required
- Ability to safely and successfully operate a motor vehicle is required. Valid Driver’s License and a driving record in compliance with company standards
- Position may require ability to travel 50%+ as needed of time or more including occasional overnight stay driven by business need.
- Must be able to work evenings and weekends, as needed, for physician or patient events (both in person and virtual).
- Depending on geography, must have the ability to manage a multi-state territory with diverse customer base.

**Benefits:**

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

- Competitive health and wellness coverage (structure and premiums vary by country)
- Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
- Flexible work arrangements / hybrid schedule

*Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.*

**Equal Employment Opportunity:**

*Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.*

**Reasonable Accommodation:**

If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.

**Privacy**

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at [Privacy Policy - Beeline Medicines](<https://beelinemedicines.com/privacy-policy/>)

Senior Medical Director, Clinical Development

**About Beeline Medicines:**

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

**Job Summary:**

The Senior Medical Director, Clinical Development is a senior physician-scientist who provides strategic medical leadership for one or more clinical programs within the organization’s Inflammation & Immunology pipeline. Building on deep therapeutic area expertise and a proven track record in clinical trial execution, this role bridges hands-on clinical program leadership with broader cross-functional and organizational accountability. The Senior Medical Director serves as the primary physician lead for assigned assets, owning the clinical strategy and development plan across multiple phases, while also playing an increasingly prominent role in shaping departmental capabilities, mentoring junior physicians, and contributing to portfolio-level decision-making. This role requires the ability to work with independence and authority in a fast-paced, growth-stage biopharmaceutical environment.

**Work Arrangement & Location:**

**Hybrid -** This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as **Tuesday and Wednesday**. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

**Essential Duties and Responsibilities:**

- Serve as the physician medical lead for assigned clinical development programs — owning the clinical development strategy, integrated development plan, and medical decision-making for pipeline assets across Phase I through Phase III development, with increasing accountability for program-level outcomes and portfolio contributions.
- Lead the design, authorship, and review of clinical trial protocols, investigator brochures, informed consent documents, and clinical sections of regulatory submissions (IND, NDA/BLA, global filings) — ensuring scientific rigor, patient safety, and regulatory compliance across all deliverables.
- Provide comprehensive medical oversight of ongoing clinical trials — including safety monitoring, medical monitoring, SAE assessment, protocol deviation review, and benefit-risk evaluation — in close partnership with Clinical Operations, Pharmacovigilance, and Biostatistics.
- Lead and actively represent the organization in regulatory agency interactions — including FDA and EMA meetings, briefing document development, and responses to health authority questions — serving as a primary medical spokesperson for assigned programs and contributing to regulatory strategy.
- Support pharmacovigilance activities during trial conduct — Drive cross-functional clinical program teams as the senior medical lead — providing strategic scientific direction to Clinical Operations, Regulatory Affairs, Translational Medicine, Biostatistics, and Medical Affairs — and ensure integrated, high-quality program execution with clear accountability and pace.
- Build and maintain relationships with key opinion leaders (KOLs), principal investigators, and academic medical centers to strengthen the organization’s clinical network, gather external scientific insights, and support the medical positioning of pipeline assets.
- Perform other duties and responsibilities as assigned

**Qualifications:**

- Education: Advanced clinical degree (MD or DO) required. Board certification or clinical training in rheumatology, nephrology, immunology, or a related specialty strongly preferred. Additional advanced degree (PhD, MPH, or MBA) is a plus.
- Minimum of 10 years of combined clinical and pharmaceutical/biotech industry experience, with a minimum of 5 years in a clinical development role with increasing levels of responsibility preferred
- Deep scientific expertise in autoimmune disease — rheumatology preferred.
- Demonstrated experience as a physician lead on Phase I–III clinical programs, including hands-on protocol development, medical monitoring, and regulatory submission experience
- Deep clinical and scientific expertise in immunology and inflammation— including command of disease mechanisms, clinical trial landscapes, standard of care evolution, regulatory developments, and emerging therapeutic approaches
- Proven ability to identify, characterize, and mitigate clinical, operational, and regulatory risks across multi-site, multinational clinical programs
- Demonstrated ability to serve as the senior medical authority on cross-functional program teams — setting scientific direction, resolving complex medical questions, and building alignment across diverse functional stakeholders
- Strong track record of leading clinical programs through critical milestones — including first-in-human studies, proof-of-concept readouts, pivotal trial initiation, and regulatory submissions — with a bias for rigor, speed, and quality
- Effective at delivering data-driven recommendations to senior leadership, adapting communication to drive informed decision-making at the organizational and portfolio level
- Collaborative and influential leader who builds trust and credibility with clinical investigators, KOLs, and regulatory agencies — leveraging scientific expertise and interpersonal effectiveness to advance the organization’s programs and reputation
- Exceptional scientific and medical communication skills — able to present complex clinical data, safety findings, and development strategies clearly and compellingly to diverse audiences including regulators, investigators, executives, and patient communities
- Skilled in authoring and reviewing high-quality clinical documents including protocols, investigator brochures, clinical study reports, regulatory briefing documents, and scientific manuscripts

**Salary Range:**

The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

Salary Range

$293,000 - $379,500 USD

**Benefits:**

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

- Competitive health and wellness coverage (structure and premiums vary by country)
- Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
- Flexible work arrangements / hybrid schedule

*Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.*

**Equal Employment Opportunity:**

*Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.*

**Reasonable Accommodation:**

If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.

**Privacy**

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at [Privacy Policy - Beeline Medicines](<https://beelinemedicines.com/privacy-policy/>)

Clinical Engagement Lead - Brazil

**About Beeline Medicines:**

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

**Job Summary:**

The Clinical Engagement Lead, is a field-based is a senior level, site facing clinical development professional responsible for building and managing investigator and site relationships across the globe in support of the organization's clinical trial portfolio. This role serves as the primary site-facing liaison between the organization and its global clinical investigators, academic medical centers, and research sites — supporting site identification, investigator engagement, and clinical trial execution to position the organization’s I&I programs competitively in the clinical research landscape. The Clinical Engagement Lead combines knowledge of the I&I therapeutic area with strong relationship management skills and a thorough understanding of clinical trial operations — serving as a trusted partner to investigators and a critical field intelligence link back to the internal Clinical Development and Medical Affairs teams. This is a highly visible, externally focused role that requires the ability to represent the organization’s science with authority, build lasting relationships with leading clinical researchers, and operate independently across a broad assigned geography.

**Work Arrangement & Location:**

**Field-Based -** This position is field-based, and the incumbent will be expected to work within their assigned territory or region on behalf of the company. Regular travel within the designated geography is an inherent requirement of this role. Additional travel outside of the assigned territory may be required based on business need, including attendance at company meetings, training, or other organizational events.

**Territory Assignment Notice:**

Brazil and other LATAM countries as assigned.

Notice: The geographic territory outlined for this position reflects current business needs and is subject to change at the discretion of the organization. Territory boundaries, state assignments, and regional alignments may be modified at any time based on evolving business priorities, organizational restructuring, or strategic initiatives. The selected candidate will be expected to adapt to any such changes as a condition of employment.

**Essential Duties and Responsibilities:**

- Build and manage a portfolio of region/country investigator and clinical site relationships in the I&I therapeutic area — identifying, engaging, and developing long-term partnerships with principal investigators, academic medical centers, community research sites, and subspecialty practices relevant to Beeline's clinical programs.
- Lead site identification and feasibility activities for clinical trials — conducting operational site assessments, evaluating investigator interest and patient population access, and providing strategic recommendations to Clinical Development and Clinical Operations on site selection and activation.
- Serve as the primary clinical liaison to regional/country level investigators — facilitating peer-to-peer scientific exchange on Beeline's pipeline, conducting protocol discussions, supporting site initiation and training, and maintaining ongoing engagement with investigators throughout the trial lifecycle.
- Support clinical trial enrollment and retention at region/country sites — working proactively with investigators and site staff to identify enrollment challenges, implement site-level solutions, and maintain site motivation and engagement across all active Beeline studies.
- Capture and communicate region/country clinical landscape intelligence — including investigator perspectives, competitive trial activity, site capacity trends, and unmet medical need insights — back to Clinical Development, Medical Affairs, and Commercial teams in a structured, actionable manner.
- Partner with Medical Affairs MSLs to ensure coordination and alignment of scientific engagement activities at the investigator level — establishing clear boundaries between clinical trial support and medical affairs activities and collaborating to maximize the impact of both.
- Represent organization clinical and scientific meetings, investigator symposia, disease-area conferences, and site visits — engaging with the clinical research community as a credible, knowledgeable, and trusted organizational representative.
- Develop and implement site engagement strategies to improve study start-up, enrollment performance, retention, and site satisfaction.
- Partner closely with investigators, study coordinators, and site staff to support patient identification and recruitment efforts.
- Provide operational guidance and best practices to sites related to diverse patient enrollment and community engagement.
- Conduct regular field engagement with investigative sites and community stakeholders to strengthen study execution and recruitment performance.
- Monitor enrollment trends, site performance metrics, and patient engagement effectiveness using data-driven approaches.
- Identify enrollment risks proactively and implement mitigation and recovery plans.
- Perform other duties and responsibilities as assigned.

**Qualifications:**

- Education: Bachelors degree in scientific or related discipline required. Advanced degree preferred—MS or MPH in a relevant clinical, biomedical, or pharmaceutical sciences discipline.
- 8+ years of experience in clinical development, clinical research, clinical operations, or a field-based clinical engagement role within the pharmaceutical or biotech industry.
- Demonstrated experience managing investigator relationships and supporting clinical trial site activation and enrollment.
- Experience in immunology, inflammation, or a related therapeutic area strongly preferred.
- Experience collaborating with CROs, investigative sites, and field medical teams, including MSL partnerships.
- Strong scientific and clinical knowledge of immunology and inflammation — including disease biology, standard of care, clinical trial design considerations, and the competitive clinical research landscape across relevant I&I indications.
- Expertise in clinical trial site management and investigator engagement — including site feasibility assessment, investigator identification and qualification, site initiation support, and enrollment optimization strategies.
- Working knowledge of GCP requirements, ICH guidelines, and FDA regulations governing investigator interactions, clinical site oversight, and field-based clinical development activities.
- Highly self-directed field professional — manages a complex investigator portfolio independently, prioritizes site engagement activities strategically, and operates with minimal supervision across a broad geography.
- Relationship-driven and trusted clinical trial resource — builds genuine, long-term partnerships with investigators and site staff based on scientific credibility, reliability, and authentic commitment to supporting research excellence.
- Proactive field intelligence contributor — consistently translates field observations into actionable insights that improve program strategy, site selection, and enrollment performance.
- Professional fluency in English (written and verbal) required
- Ability to safely and successfully operate a motor vehicle is required. Valid Driver’s License and a driving record in compliance with company standards
- Position may require ability to travel 50%+ as needed of time or more including occasional overnight stay driven by business need.
- Must be able to work evenings and weekends, as needed, for physician or patient events (both in person and virtual).
- Depending on geography, must have the ability to manage a multi-state territory with diverse customer base.

**Benefits:**

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

- Competitive health and wellness coverage (structure and premiums vary by country)
- Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
- Flexible work arrangements / hybrid schedule

*Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.*

**Equal Employment Opportunity:**

*Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.*

**Reasonable Accommodation:**

If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.

**Privacy**

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at [Privacy Policy - Beeline Medicines](<https://beelinemedicines.com/privacy-policy/>)

Clinical Engagement Lead - China

**About Beeline Medicines:**

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

**Job Summary:**

The Clinical Engagement Lead, is a field-based is a senior level, site facing clinical development professional responsible for building and managing investigator and site relationships across the globe in support of the organization's clinical trial portfolio. This role serves as the primary site-facing liaison between the organization and its global clinical investigators, academic medical centers, and research sites — supporting site identification, investigator engagement, and clinical trial execution to position the organization’s I&I programs competitively in the clinical research landscape. The Clinical Engagement Lead combines knowledge of the I&I therapeutic area with strong relationship management skills and a thorough understanding of clinical trial operations — serving as a trusted partner to investigators and a critical field intelligence link back to the internal Clinical Development and Medical Affairs teams. This is a highly visible, externally focused role that requires the ability to represent the organization’s science with authority, build lasting relationships with leading clinical researchers, and operate independently across a broad assigned geography.

**Work Arrangement & Location:**

**Field-Based -** This position is field-based, and the incumbent will be expected to work within their assigned territory or region on behalf of the company. Regular travel within the designated geography is an inherent requirement of this role. Additional travel outside of the assigned territory may be required based on business need, including attendance at company meetings, training, or other organizational events.

**Territory Assignment Notice:**

China and other APAC countries as assigned.

Notice: The geographic territory outlined for this position reflects current business needs and is subject to change at the discretion of the organization. Territory boundaries, state assignments, and regional alignments may be modified at any time based on evolving business priorities, organizational restructuring, or strategic initiatives. The selected candidate will be expected to adapt to any such changes as a condition of employment.

**Essential Duties and Responsibilities:**

- Build and manage a portfolio of region/country investigator and clinical site relationships in the I&I therapeutic area — identifying, engaging, and developing long-term partnerships with principal investigators, academic medical centers, community research sites, and subspecialty practices relevant to Beeline's clinical programs.
- Lead site identification and feasibility activities for clinical trials — conducting operational site assessments, evaluating investigator interest and patient population access, and providing strategic recommendations to Clinical Development and Clinical Operations on site selection and activation.
- Serve as the primary clinical liaison to regional/country level investigators — facilitating peer-to-peer scientific exchange on Beeline's pipeline, conducting protocol discussions, supporting site initiation and training, and maintaining ongoing engagement with investigators throughout the trial lifecycle.
- Support clinical trial enrollment and retention at region/country sites — working proactively with investigators and site staff to identify enrollment challenges, implement site-level solutions, and maintain site motivation and engagement across all active Beeline studies.
- Capture and communicate region/country clinical landscape intelligence — including investigator perspectives, competitive trial activity, site capacity trends, and unmet medical need insights — back to Clinical Development, Medical Affairs, and Commercial teams in a structured, actionable manner.
- Partner with Medical Affairs MSLs to ensure coordination and alignment of scientific engagement activities at the investigator level — establishing clear boundaries between clinical trial support and medical affairs activities and collaborating to maximize the impact of both.
- Represent organization clinical and scientific meetings, investigator symposia, disease-area conferences, and site visits — engaging with the clinical research community as a credible, knowledgeable, and trusted organizational representative.
- Develop and implement site engagement strategies to improve study start-up, enrollment performance, retention, and site satisfaction.
- Partner closely with investigators, study coordinators, and site staff to support patient identification and recruitment efforts.
- Provide operational guidance and best practices to sites related to diverse patient enrollment and community engagement.
- Conduct regular field engagement with investigative sites and community stakeholders to strengthen study execution and recruitment performance.
- Monitor enrollment trends, site performance metrics, and patient engagement effectiveness using data-driven approaches.
- Identify enrollment risks proactively and implement mitigation and recovery plans.
- Perform other duties and responsibilities as assigned.

**Qualifications:**

- Education: Bachelors degree in scientific or related discipline required. Advanced degree preferred—MS or MPH in a relevant clinical, biomedical, or pharmaceutical sciences discipline.
- 8+ years of experience in clinical development, clinical research, clinical operations, or a field-based clinical engagement role within the pharmaceutical or biotech industry.
- Demonstrated experience managing investigator relationships and supporting clinical trial site activation and enrollment.
- Experience in immunology, inflammation, or a related therapeutic area strongly preferred.
- Experience collaborating with CROs, investigative sites, and field medical teams, including MSL partnerships.
- Strong scientific and clinical knowledge of immunology and inflammation — including disease biology, standard of care, clinical trial design considerations, and the competitive clinical research landscape across relevant I&I indications.
- Expertise in clinical trial site management and investigator engagement — including site feasibility assessment, investigator identification and qualification, site initiation support, and enrollment optimization strategies.
- Working knowledge of GCP requirements, ICH guidelines, and FDA regulations governing investigator interactions, clinical site oversight, and field-based clinical development activities.
- Highly self-directed field professional — manages a complex investigator portfolio independently, prioritizes site engagement activities strategically, and operates with minimal supervision across a broad geography.
- Relationship-driven and trusted clinical trial resource — builds genuine, long-term partnerships with investigators and site staff based on scientific credibility, reliability, and authentic commitment to supporting research excellence.
- Proactive field intelligence contributor — consistently translates field observations into actionable insights that improve program strategy, site selection, and enrollment performance.
- Professional fluency in English (written and verbal) required
- Ability to safely and successfully operate a motor vehicle is required. Valid Driver’s License and a driving record in compliance with company standards
- Position may require ability to travel 50%+ as needed of time or more including occasional overnight stay driven by business need.
- Must be able to work evenings and weekends, as needed, for physician or patient events (both in person and virtual).
- Depending on geography, must have the ability to manage a multi-state territory with diverse customer base.

**Benefits:**

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

- Competitive health and wellness coverage (structure and premiums vary by country)
- Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
- Flexible work arrangements / hybrid schedule

*Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.*

**Equal Employment Opportunity:**

*Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.*

**Reasonable Accommodation:**

If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.

**Privacy**

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at [Privacy Policy - Beeline Medicines](<https://beelinemedicines.com/privacy-policy/>)

Dren Bio

Clinical Trial Manager/ Senior Clinical Trial Manager

Clinical Trial Manager/ Senior Clinical Trial Manager

About the Company:

Dren Bio is a privately held, clinical-stage biopharmaceutical company pioneering the discovery and development of first-in-class antibody therapeutics for the treatment of cancer, autoimmune disorders, and other serious diseases. Leveraging our wholly owned technologies, we have built a robust R&D pipeline, including two clinical-stage candidates currently being evaluated across multiple ongoing clinical studies. Our lead clinical candidate, dibotatug, is designed to induce antibody-mediated killing of a specific cell type implicated in a range of oncology and autoimmune indications. In addition, we have launched multiple programs from our proprietary Targeted Myeloid Engager and Phagocytosis Platform, a multispecific antibody-based technology engineered to selectively engage a novel phagocytic receptor expressed on myeloid cells (antigen presenting cells) for the targeted depletion of pathologic cells and other disease-causing agents. Data generated using the platform support its broad therapeutic potential, including initial programs focused on oncology, immunology, and neurology. Importantly, multispecific antibodies generated from the platform are specially designed to activate phagocytic mechanisms only in the presence of disease targets, potentially offering a superior safety profile compared to other immunomodulatory therapies. For more information, please visit our website at www.drenbio.com.

Function:

Clinical Operations

Level:

Manager/ Senior Manager

Location:

San Carlos, CA (Remote candidates may be considered)

Reporting Manager:

Associate Director, Clinical Study Management

About the Opportunity:

We are seeking an exceptionally talented and driven individual for the Clinical Trial Manager/ Senior Clinical Trial Manager position. This role will be responsible for providing operational execution, leadership and support for studies conducted by the Dren Bio team, and work in partnership with internal colleagues, external partners, and investigators and clinical site staff to ensure delivery of high quality clinical studies in a timely manner.

Role and Responsibilities:

- Responsible for clinical study execution and oversight of all operational aspects
- Lead in-house study management in the United States (no CRO contracted for US studymanagement)
- Contribute to the identification and selection of appropriate ex-US CROs andthird-party study vendors
- Oversee performance of ex-US CROs and vendors to ensure study execution
- Develop study training slides and materials and train study team members and vendorson study protocol, associated documents, and key decisions and communications
- Ensure study team members and vendors are trained on protocol, relevant studydocuments, and key decisions at study start-up and throughout the duration of thestudy
  Manage the development of clinical protocols, amendments, informed consent forms,study plans and any other clinical research related documents, in collaboration withcross-functional team members or CRO-partners
  Organize and run study team meetings on a regular basis to ensure clear and currentcommunication, escalation of potential issues to the appropriate functional leadsand team-based problem solving and risk mitigation of any arising roadblocks
  Establish and maintain excellent working relationships with investigators and studystaff
  Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCPguidelines and study specific manuals and procedures
  Participate in feasibility process for finding and selecting new study sites
  Oversee CTA management of site start-up activity
  Work with central laboratory vendor on lab specifications, manual, and kit design anddatabase build
  Work with central imaging vendor on specifications, charter, manual, supplies, andvendor portal database build
  Work with IRT vendor on specifications, build, testing, and manual for drug supplymanagement system
  Review and contribute to CRF design and database build to ensure integration of allcritical aspects of the clinical study being reflected in the clinical database
  Collaborate with Data Management to oversee data quality issues (query and dataquality management and resolution)
  Lead Clinical Operations team in planning and execution of data cleaning for datadeliverables.
  Cohort screening and enrollment management in coordination with Medical Monitor
  Collaboration with Medical Monitor and Safety to prepare data and communications fordose escalation Safety Review Committee and DSMB meetings
  Guide, in conjunction with the CRA lead, the monitoring activity of CRAs and timelyexecution of data clean efforts to ensure timely data entry and continuous dataquality improvements
  Review and communicate key study quality metrics (e.g., eligibility, primary endpointdata, etc.) and determine appropriate action in conjunction with study team
  Collaborate with cross-functional teams (e.g., regulatory, translational research,quality, CMC, statistics, etc) in study start-up planning as well as to coordinateefforts for study deliverables (e.g., regulatory submissions, sample reconciliation,PK and exploratory biomarker analyses, SOP development, drug supply projections,pharmacy manual and IP management, developing data cleaning timelines forstats/programming TLF deliverables, etc)

Education, Experience and Qualification Requirements:

- BS/BA in the life sciences or in a related field; an advanced degree (e.g., MS,PharmD, or PhD) is preferred
- 5-7 years of experience in clinical operations for biotechnology or pharmaceuticalemployer; experience in autoimmune disease(s) or dermatology highly desirable.Experience with internal model (in-house, non-CRO study management) highlydesirable.
- Experience with clinical systems including various EDC, IRT, TMF, CTMS, etc.
- Strong organizational, written and verbal communication skills
- Willingness to travel up to 30% of the time.
- Permitted to work in the United States.

Core Competencies, Knowledge and Skill Requirements:

- A self-starter who can take on building the operational backbone for early phaseclinical studies
- Experienced in leading international Phase I-III clinical trials
- Participation in large multi-center and/or global trials, investigational site andCRO management, data collection, and study protocol compliance.
- Solid understanding of US and global regulations and guidelines (FDA, EMA, ICH)
- Experience in working in a highly matrix environment and ability to execute in thecontext of internal and external (vendor) cross-functional teams
- Desire to learn and grow in terms of scientific knowledge, managerial capabilitiesand personal development
- Willingness to take a hands-on approach
- Ability to work under pressure and aggressive timelines
- Ability to manage multiple competing priorities, being able to rapidly gather,assimilate and disseminate information on critical project components and milestones
- Detail oriented with ability to manage technical/scientific aspects as well asoperational components of logistics, timing and quality

Salaries, Benefits and Other Employee Perks:

Dren Bio strongly believes in investing in, and rewarding, its employees. This philosophy is embodied in the Company’s total rewards program, which includes competitive cash compensation, equity incentive awards, and employer sponsored benefit offerings. The base pay range for this position at commencement of employment is expected to be between $120,000 and $170,000 per year. At Dren Bio, pay ranges are determined by role, level(s), and location. The range displayed in this job posting reflects the minimum and maximum new hire pay for candidates located across all United States job markets. Within the range, individual pay will be determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, Dren Bio’s Human Resources department can share more about the specific pay range based on the market location of the candidate.

Employment Practices:

Dren Bio is an equal opportunity employer. Employment decisions are based on merit and business needs. Dren Bio will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law.