Marketing

Nurix Therapeutics

Senior Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology)

**Senior Manager / Associate Director, Regulatory Affairs (Strategy, Hematology Oncology)**

*Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.*

**Job Summary:**

In this role, you will be a core member of the Regulatory team and will be responsible for helping build and execute on global regulatory strategy, objectives, policies and programs pertaining to development and future marketing of products.

**Responsibilities:**

- Provides regulatory strategic direction and support for assigned global development programs/development program activities
- Assists Sr. Regulatory Affairs staff with their development program activities and deliverables
- Designs and implements regulatory strategies with Regulatory Affairs staff to obtain and maintain product investigative and marketing applications for assigned programs, as well as their life cycle management
- Acts as regulatory representative on early and/or late phase clinical studies, ensuring compliant execution of trials
- Strong competency in understanding regulatory requirements and emerging regulatory landscapes associated with US and global regulatory authorities
- Experienced in responding to inquiries from global regulatory authorities as well as the preparation and conduct of meetings with global regulatory authorities
- Assist in the preparation and maintenance of Annual Reports, Development Safety Update Reports (DSURs), Investigator’s Brochures and other documents required for INDs, CTAs, NDAs and other related regulatory development and marketing applications
- Assist in the cataloging and maintenance of regulatory application submissions
- Conduct research and stay up-to-date on regulatory requirements and changes
- Collaborate with cross-functional teams to ensure product compliance throughout the development lifecycle
- Monitor and assess regulatory risks and develop mitigation strategies
- Oversee quality assurance processes to ensure compliance with regulatory standards
- Review SOPs pertaining to Regulatory
- Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix’s investigational and marketing applications
- Plays an essential part in defining requirements for, implementing, and supporting future systems and tools to be employed by Nurix in the areas of document management, submission content planning, and regulatory information management
- Tracks the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependencies
- Develops and maintains submission plan templates to ensure Nurix regulatory submissions are consistently planned and executed across programs
- Participates in cross-functional process initiatives impacting regulatory submission processes and systems
- Manages consultants and contractors as needed

**Experience and Skills:**

- Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred Manager:
- Must have minimum of 8 years in Regulatory affairs strategy
- Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulations
- Experience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMA
- Ability to read, analyze and interpret scientific and technical information, as well as regulatory
- Ability to understand and explain detailed regulatory affairs and compliance programs and/or to effectively present information to senior regulatory management, other departments or external
- Ability to comply with changing regulatory
- Proven track record of supporting Regulatory affairs in the planning and execution of major filings and ongoing maintenance of clinical trial and marketing applications
- Strong project management and critical thinking skills
- Experience applying project management techniques and tools (e.g., MS Project, Smartsheet, Excel trackers) to the planning and execution of regulatory submissions
- Excellent organizational and communication skills, both written and verbal
- Ability to work independently as well as part of a team environment
- Positive attitude, energetic and proactive
- Proven ability to manage multiple projects, identify and resolve regulatory issues
- Strong interpersonal skills and the ability to effectively work with others

**Fit with Nurix Culture and Values**

- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view

**Salary Range:** SM $187,800 - $208,638 AD $199,500 - $231,200

**Location:**  Brisbane, CA - Onsite

California

Insmed Incorporated

Director, Patient Marketing

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 are looking for a Director of Patient Marketing to lead the development of a robust multi-channel patient media strategy. Reporting to the Senior Director, Patient Marketing, this individual will design and optimize branded and unbranded initiatives that educate and support patients throughout their entire journey. By blending deep patient insights with data analytics, this individual will collaborate with cross-functional teams to create meaningful experiences that meet patient needs and accelerate brand growth.

**What You'll Do:**

In this role, you’ll have the opportunity to transform insights into strategic actions and leverage learnings to refine marketing approaches, optimize campaign performance and ensure the patient voice drives marketing decisions. You’ll also:

- Drive patient engagement strategy through multi-channel marketing and high-impact creative messaging.
- Lead the strategy and execution of a robust multi-channel media plan (TV, digital, social) by aligning high-impact content delivery (ads, videos, website) to patient preferences and patterns.
- Develop, deploy, and continuously optimize unbranded and branded communications and media assets, to ensure strong patient education and engagement.
- Establish goals and critical metrics to measure the effectiveness of marketing initiatives, with a focus on continuous learning and data-driven optimization.
- Collaborate across functions – including franchise marketing teams, healthcare provider and payer marketing, product communications, patient services, information technology, sales, commercial effectiveness, advocacy, compliance, medical, legal and regulatory teams.
- Effectively engage agency partners, handle scopes of work and develop plans to ensure timely execution of initiatives; Foster a collaborative relationship to drive team success.
- Build business cases to secure necessary investment, contribute to Patient Marketing budget management, and ensure tracking of resources.
- Collaborate in building scenario-based investment recommendations that directly support brand goals, strategic imperatives and critical success factors

**Who You Are:**

You have a BS degree in marketing or similar field, along with 10 years pharmaceutical experience in brand management/marketing in the biotechnology/pharmaceutical industry.

You are or you also have:

- Patient marketing experience, in a fast-paced environment
- Proven track record in multi-channel media and planning and execution, including website strategy
- A creative, “what’s possible” attitude that always puts the patient first
- Sharp analytical capabilities– able to dissect data to uncover insights and turn them into impactful actions
- Excellent communication and storytelling – written, verbal and visual
- Skilled in both strategy and execution - with strong marketing fundamentals
- Experience in managing external partners (e.g. consultants, agencies) required

**Where You’ll Work**

This is a hybrid role based out of ourBridgewater, NJoffice.You’llwork remotely most of the time, with in-person collaboration when it matters most.

**Travel Requirements**

This role requires occasional domestic travel, up to 15%.

\#LI-TB1

\#LI-Hybrid

**Pay Range:**

$177,000.00-242,000.00 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.*

New Jersey

Associate Director/ Senior Manager, Value Evidence and Outcome - 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:**

To fulfill Japan Medical Affairs’ (J-MA's) Value Proposition of "realizing a desirable healthcare environment," the following roles are undertaken:

The Associate Director (Assoc Dir) or Sinor Manager (Sr Mgr), Value Evidence and Outcomes (VEO) plays a crucial role within the VEO/ Publication & Scientific Communication (Sci Comm) Team in Medical Affairs of Japan. The Asso Dir or Sr Mgr of VEO is responsible for planning and executing of a comprehensive Japan Evidence Generation Strategy, ensuring the development of meeting-to-unmet medical needs (UMNs), feasible, ethically compliant that align with Insmed business including strategic imperatives and Strats/Brand Plan, Health Economics & Outcomes Research (HEOR) strategies, and Japan medical strategies of Insmed portfolio.

The Asso Dir or Sr Mgr of VEO collaborates closely with various cross-functional teams within Insmed, including, but not limited to, the HEOR, Global Medical Strategy, Sci Comm & Publication Team, each function of Japan MA, Clinical Development (CD), Commercial, and Market Access & Pricing/Patient Advocacy of Insmed GK, as well as external stakeholders and venders.

This position reports to the Director, VEO/Publication & Sci Comm in Medical Affairs of Japan and is based at the Tokyo Office.

**What You'll Do:**

- **Identify Data Gap and Resolvable Local UMNs**: Identify data gap through systematic literature search and expert insights in collaboration with the Strategic Leads of J-MA, and determine resolvable local UMNs using various evidence-generation approaches, including health technology assessment (HTA). Select optimal methods or study designs, implement studies and deliver meaningful outcomes.
- **Lead to Develop Japan VEO Plans:**  Lead the development of J-VEO/ Evidence Generation Plans to address identified resolvable UMNs, considering feasibility, budget and timing, ensuring alignment with Insmed business including strategic imperatives and Strats/ Brand Plan, HEOR strategies, and Japan medical strategies of Insmed portfolio.

The VEO/ Evidence Generation Plans include, but not limited to, efficacy and safety assessments, epidemiology, real-world status (e.g. patient burden, effectiveness, adherence, treatment patterns, and clinical situation), costing analyses, and development of expert consensus and diagnostic/progression algorithms. Methods may include interventional and observational studies, patient-reported outcomes (PRO), pre-existing data analysis (e.g. claim/DPC database, medical chart, completed clinical study datasets) Delphi panels, and leveraging AI.

- **Lead to Implement Company Sponsored Studies (CSS) activities:**  Lead the implementation of day-to-day activities related to CSSs. Ensure that all activities are executed in compliance with regulatory requirements (GCP), local lows (Clinical Study Act), guidelines (GLs) (Ethical GLs for Life Science/ Medical and Health Research Involving Human Subjects), company policies and SOPs, and applicable ethical standards
- **Share and Update Study Information:**  Provide updated information and outcomes from HEOR/VEO studies or projects to Pub & Sci Comm Team for facilitate effective publications and data dissemination.
- **Publication Involvement:**  Actively participate in publications related to responsible studies, either as an author or presenter in collaboration with Local Publication Lead. This includes taking on presenter roles for encore presentations.
- **Support of HEOR-Sponsored Studies:**  Support HEOR-sponsored studies, e.g. assist in identifying local experts, maintaining continuous communication, discussing protocol and outcomes, and supporting study set-up. This includes obtaining approvals of study materials from J-Medical Review Committee, due diligence on local venders, and communication with Global venders to drive the studies forward.
- **Provide Epidemiological Data:**  Support the provision of estimated epidemiological data for clinical trials, J-NDA and pricing strategies using available data sources.
- **Collaboration with Market Access and Pricing Team:** Work closely with the Market Access and Pricing Team to develop and execute high-quality health economic strategies. Focus on maintaining NHI price for Insmed portfolio by delivering robust evidence that demonstrates product value and drives business objectives. Prepare cost-effectiveness analysis (CEA) reports to present the value of Insmed products from an HTA perspective and respond to inquiries from the C2H and CEA Evaluation Bodies of Japanese Authorities.
- **Build Effective Partnerships:**  Establish strong relationships with all stakeholders, including, but not limited to, external experts, the HEOR Team and Strategic and Sci Comm & Publication Teams of Global MA (GMA), CD and DSPV in both Global and Local. Collaborate with other functions within J-MA, and Market Access & Pricing/Patient Advocacy, Legal/ Compliance, and working groups.
- **Information Maintenance (Data Source and Medical Venders):**  Actively search for, collect and maintain current and updated information regarding data sources for CSSs, such as commercial databases, academic registries and internal data (including clinical trials, PMS, market research). Additionally, track details about CROs, medical agencies, and venders, including their capabilities, standard budgets/ timelines and contract status.
- **Local Publication Monitoring:**  Conduct a monthly search of the status of current local publications in targeted therapeutic areas and share this information with internal stakeholders to understand about the evolving medical landscape in Japan.

**Who You Are:**

- **Educational Requirements:**  A Master’s degree in a scientific discipline or equivalent experience in required elements (see below) is mandatory. An advanced degree (e.g., PhD, PharmD or MD) is highly preferred. Scientific expertise in pulmonology, bacterial infection, cardiovascular diseases and/or allergy/ immunology is highly valued. Possession of an HTA certificate is also preferred.

For MD holders, must possess a presently active medical license for the practice of medicine in Japan (foreign license holder will NOT be considered). A board certification in pulmonology, bacterial infection, cardiology and/or allergy/ immunology is highly valued.

- **Professional Experience:** Minimum 10 years’ relevant experience in the pharmaceutical/biotech industries within a Global setting, specifically in Japan, with a solid understanding of the pharmaceutical business, including drug research, development, manufacturing and commercialization. At least 5 years’ experience in evidence generation, with expertise across all aspects of evidence generation strategy, planning, and execution during all phases of drug development, particularly, in the post-launch/ marketed product phase. Alternatively, equivalent experience in academia or other health care delivery setting (e.g. health economics consulting company) may also be considered.
- **Key Competencies:** Broad experience and reliable understanding in variety of evidence generating approaches and methods.

Solid experience in playing critical roles in planning (e.g., development of study outline, protocols and SAPs) and managing operations (e.g., vendor selection/ management, feasibility assessment, expert consultations, and managing budgets and timelines) for clinical research.

For the Sr Mgr role, if certain "Responsibilities" are not fully met, their other competencies, such as assisting the Team Leaders and demonstrating biostatistical knowledge, will be considered to assess whether they can effectively fulfill the VEO responsibilities without any issues.

**\<Essential Requirements\>**

- Company sponsored-GCP study: 2 or more
- PMS study: at least 1 study
- PRO studies: 2 or more
- Studies using pre-existing datasets (e.g., clinical trials, PMS, chart reviews): 5 or more

**\<Highly Preferred Experience\>**

- Systematic review and meta-analysis (or experience in literature gap analysis): 3 or more
- HTA-related research:At least 1 study
- o Expert consensus development using the Delphi method: 1 or more
- Database studies using commercial databases (e.g., JMDC, MDV, etc.) :At least 3 studies
- Development of algorithms for disease diagnosis/progression using AI: 1 or more

- **HTA and CEA Knowledge:** Understanding of the HTA system and processes in Japan, including the CEA GLs by MHLW. Experience implementing CEA and familiarity with analysis software like ‘TreeAge’ is valued.
- **Compliance and Ethical Standards:**  Adherence to uncompromising ethical standards, including but not limited to, applicable local and global policies, regulations, laws and guidelines such as: GCP, Clinical Study Act, Ethical GLs for life science/ medical and health research involving human subjects, GLs of International Committee of Medical Journal Editors (ICMJE)/Good Publication Practice 4 (GPP4), company policy and SOPs as well as compliance policies and requirements, Japan Pharmaceutical of Manufacturers Association (JPMA) GLs, and Guidelines for Provision of Sales Information on Prescription Drugs.
- **Language and Communication Skills:** Native-level fluency in Japanese and high-level business fluency in English is a must. Excellent written and verbal communication and presentation skills, with the ability to effectively convey complex scientific and clinical data to both internal and external stakeholders (e.g., scientific congresses, meetings with Global teams).
- **Key attributes for success:**  Leadership and analytical skills with the ability to work autonomously and within cross-functional teams. Effective management of multiple workstreams while maintaining the ability to prioritize tasks.

**Where You’ll Work**

This role is based out of our Tokyo office with weekly flexibility to support both your professional and personal needs.

**Travel Requirements**

This role requires occasional domestic/global travel up to 30%

**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。

**_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

Director, Access Programs

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 remote Director, Access Programs on the Commercial Operations & Channel Management team to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, Head of Channel, Distribution and Access Programs, you’ll be responsible for the strategy and management of Insmed’s Patient Assistance and Copay programs, focusing on optimization of program business rules, strategic vendor management and data insights to manage appropriate patient affordability solutions. This role serves as the primary business owner of the affordability programs and vendors as well as cross-functional work with Market Access, Finance, Legal, Compliance and Product Teams to deliver patient solutions aligned with business objectives.

**What You'll Do:**

In this role, you’ll have the opportunity to oversee strategic management of the PAP and Copay vendor programs, including performance tracking, service level agreements, quality standards, issue resolution and budget oversight . You’ll also:

- Establish and maintain SOPs, documentation standards and quality controls to ensure operational excellence
- Partner with Patient Service Leads to evolve the PAP and Copay operating models, including workflow refinement, training, and escalation processes

- Integrate vendor data into existing dashboards to monitor operational metrics and enhance and track patient journey
- Translate data and marketplace trends to identify barriers, optimize workflow, strengthen vendor performance, and inform ongoing enhancements
- Ensure program scalability, efficiency and cost optimization through continuous process improvements
- Support issue resolution, escalation management and program audits

**Who You Are:**

You have a Bachelor's degree required; MBA or advanced degree preferred along with 7+ years of pharmaceutical / biotech experience, including patient assistance and copay programs. You are or also have:

- Proven affordability program experience (preferred PAP experience), including agreement management
- Strong knowledge of healthcare compliance and regulatory environment
- Proficiency in interpreting operational and patient journey data to drive informed decision-making
- Affordability Program Expertise:Knowledge of Patient Assistance and Copay operations
- Data-Driven Decision Making:Translates complex affordability program data into strategic action
- Strategic Thinking:Anticipates market shifts and defines long-term management or product specific strategies related to responsibilities
- Communication:Effectively conveys insights and performance narratives to internal and external audiences

**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.

**Travel Requirements**

Occasional travel for team meetings or events will be expected.

\#LI-TB1

\#LI-Remote

**Pay Range:**

$177,000.00-242,000.00 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

Global Commercial Lead, ALS & Rett

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 Global Commercial Lead, ALS & Rett on the Commercial Management – Gene Therapy team to help us expand what’s possible for patients with serious disease. Report to the Global Commercial Head, Neuro & Other Rare, you’ll be responsible for leading the successful global commercialization of Amyotrophic Lateral Sclerosis (ALS) and Rett gene therapies.

**What You'll Do:**

In this role, you'll have the opportunity to develop, implement and evolve global commercial strategy, including market shaping, patient finding, and branded & unbranded campaigns, for our neuro gene therapies portfolio, with strong emphasis on US.

You'll also:

- Create and maintain a ‘best in class’ Target Product Profile (TPP), in alignment with GPT, and therapeutic area leadership team
- Ensure commercial insights are integrated into clinical development, trial design and manufacturing scalability
- Partner with:
  - Field Leadership to achieve high-quality customer engagement, and treatment center support from treatment consideration to gene therapy administration
  - Market Access and HE&OR to shape value proposition and architect innovative access models, reflecting the high unmet need and value of our gene therapies
  - Patient Services, and Channel & Distribution to deliver an industry-leading patient and caregiver experience
  - Patient Advocacy and Medical Affairs on external engagement strategy, conference planning, and KOL & PAG engagements for ALS and other neuro disorders
- Collaborate with commercial effectiveness to proactively monitor the competitive landscape, identify customer insights & analytics needs, and build revenue forecasts
- Champion commercial priorities in GPT, therapeutic area leadership, and with cross-functional colleagues
- Build and lead a high performing marketing team, fostering patient centricity, accountability, innovation, and operational excellence

**Who You Are:**

You have a Bachelor’s degree in business, marketing, science, or related field is required (MBA or advanced degree preferred) along with 12+ years in biopharma marketing, including global commercial launch leadership in gene or cell therapy.

You are or you also have:

- Experience with and deep understanding of one-time/specialized in vivo or ex vivo therapies administered in treatment centers (e.g., gene therapies, gene editing, cell therapies)
- Proven leadership skills, and ability to select, develop, and mentor a high-performing team
- Strong analytical mindset related to market assessment, competitive intelligence, and HTA/pricing
- Ability to translate science into compelling customer value proposition and strategic narrative
- Ability to identify business opportunities and develop a research plan that will provide actionable insights
- Excellent written and verbal/presentation skills and proficient in Powerpoint, Excel, Word, SharePoint
- Ability to work in ambiguous environments and influence without authority
- Excellent collaboration and partner engagement skills, with capability to work across scientific and commercial teams

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

Experience in neurology/neuromuscular diseases is a plus

**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**

This position involves frequent travel (up to 20%) for team meetings or events will be expected.

\#LI-JT1

\#LI-Remote

**Pay Range:**

$214,000.00-292,000.00 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.*

Director, Marketing – Expert Engagement & Regional Marketing

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, Marketing – Expert Engagement & Regional Marketing on the U.S. Commercial Marketing team to help us expand what's possible for patients with serious and rare diseases. Reporting to the Global Commercial Lead, you'll coordinate the commercial U.S. expert leader strategy, drive awareness among the HCP community, and lead regional marketing across Pulmonary Arterial Hypertension (PAH), Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD), Idiopathic Pulmonary Fibrosis (IPF), and Progressive Pulmonary Fibrosis (PPF).

**What You'll Do:**

In this role, you'll have the opportunity to shape and execute expert engagement and regional marketing strategies that elevate Insmed's presence across the Pulmonary Vascular & Fibrotic Lung Disease community. You'll also:

- Collaborate with extended teams on scientific leader identification, mapping, tiering, and tactical planning — including tracking interactions and gathering actionable insights — in close collaboration with medical, advocacy, and clinical teams
- Build and maintain a robust network of U.S. regional experts, developing profiles to engage them according to their skills, experience, and preferences, while facilitating connections across the enterprise
- Design, plan, and execute commercial Advisory Boards and Expert Advisory Programs, managing end-to-end logistics, agenda design, faculty selection, and insight synthesis
- Translate advisory board outputs into actionable insights for internal stakeholders including Medical Affairs, Commercial, Market Access, and Clinical teams
- Lead the design, execution, and dissemination of unbranded awareness initiatives to elevate Insmed's role in the disease area, in partnership with scientific leaders and in coordination with corporate communications, advocacy, and medical affairs
- Identify unmet educational needs within the HCP community and lead programs that include peer-to-peer education opportunities and presentations at major congresses to drive Insmed's thought leadership footprint
- Represent the commercial team at regional congresses, coordinate engagements with regional experts to gather insights, and proactively identify emerging thought leaders
- Develop and lead commercial engagement plans with regional experts, driving awareness of Insmed's role in the community and identifying partnership opportunities in a compliant manner
- Partner with Medical Affairs and Advocacy to align engagement plans and ensure consistent messaging across teams
- Contribute to building and mentoring a strong marketing team environment, modeling a culture of compliance, accountability, and execution excellence

**Who You Are:**

You have a minimum**Bachelor's degree**(MBA or advanced degree preferred) along with**8–10+ years of experience**in pharmaceutical/biotech commercial roles, including**5+ years in U.S. regional marketing, sales, and HCP/expert engagement**, or a combination of education, training, and experience.

You are or you have:

- Demonstrated U.S. product launch experience
- Experience in pulmonary, respiratory, cardiopulmonary, rare disease, or specialty markets
- Strong strategic thinking with the ability to translate global strategy into U.S. execution
- Proven ability to develop and implement expert engagement and marketing strategies delivering measurable commercial results
- Experience leading cross-functional initiatives in complex, matrixed environments
- Strong analytical skills and comfort using data to inform decision-making
- Experience navigating promotional review and regulatory processes
- Strong executive presence with exceptional communication skills
- Ability to influence without authority and drive alignment across functions
- Authentic commitment to patients living with serious or rare diseases

**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 international travel (up to**30%-50%** ) for congresses, advisory boards, regional expert engagements, and team meetings.

\#LI-JT1

\#LI- Remote

**Pay Range:**

$177,000.00-242,000.00 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.*

Director Field Access Managers

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, Field Access Managers on the Patient Services team to help us expand what’s possible for patients with serious diseases. Reporting to the Senior Director, Field Access Managers, you’ll have a unique opportunity to lead a team of 10 Field Access Managers and deliver upon and evolve an industry leading patient experience for patients battling serious and rare diseases. The Director, Field Access Managers will leverage his/her reimbursement and access expertise and demonstrated leadership experience to lead the field-based Field Access Manager team in identifying, understanding, and addressing challenges impacting patients’ access to Insmed’s products as prescribed by the HCP. A key component of this role is to establish collaborative relationships with Field Sales, Marketing, Channel Management, Market Access, Patient Support Leadership Team, Analytics, and Compliance colleagues to support patient access. This role will be located in Northeast.

**What You'll Do:**

In this role, you’ll have the opportunity to manage a team of Field Access Managers to support HCP staff oninsurance coverage and reimbursement policies for current and potential new products.

You’ll also:

- Create a high-performance team driven by common values of trust, respect and commitment in winning the right way (culture of compliance)
- Establish a strong vision and clear objectives for the Field Access Managers that aligns with Insmed’s values
- Conduct performance evaluations, mentor, develop and lead a diverse and talented team who are competent and skilled in the healthcare marketplace and in access and reimbursement
- Collaborate with Field Sales, Market Access, and Patient Support Services leadership to proactively identify, prioritize and address patient access bottlenecks
- Provide strategic direction to Field Access Managers, and ensure their daily activities are compliantly aligned with patient access priorities within their assigned regions
- Serve as reimbursement and insurance coverage expert and coach for Field Access Managers, and ensure that the team maintains an up-to-date repository of plan-specific reimbursement and coverage criteria, forms, and submission procedures
- Communicate regularly with cross-functional leadership on Field Access Manager team’s focus and metrics
- Ensure compliance with Insmed’s policies and rules of engagement
- Track and analyze payer prior authorization outcome data along with market trends to identify areas of improvement and make appropriate recommendations

**Who You Are:**

You have a Bachelors degree along with a minimum of 10+ years of commercial experience in the pharmaceutical or biotech industry, which must include field reimbursement. Other experience that will be considered market access, payer marketing, patient support programs, and sales experience.

You are or you also have:

- 3+ years leadership experience demonstrating ability to build and sustain compliant, high performing teams
- Experience in recruiting and hiring high-performing teams required
- Experience leading a field-based reimbursement team preferred
- Leadership product launch experience required
- Specialty and rare disease experience preferred
- Excellent understanding of prescription patient journey, drug coverage/benefit design, and reimbursement process
- Demonstrated strength in strategic planning and tactical plan development and execution

**Where You’ll Work**

This is a fully remote role. It can be performed effectively from anywhere in the Northeast, 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 travel in region; up to 60%.

\#LI-TB1

\#LI-Remote

**Pay Range:**

$208,000.00-283,500.00 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.*

Director, Diagnosis Innovation & Collaboration

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, Diagnosis Innovation & Collaboration to help us expand what’s possible for patients with serious diseases and leave no patient behind. Reporting to the Diagnosis Strategy lead, you’ll be responsible for the identifying and implementing innovative approaches to diagnosis in the field of respiratory and finding external collaborations to advance this effort. You will be skilled in both strategy and execution - with an analytical mindset, strong marketing fundamentals, and a proven track-record of driving growth by uncovering unknown or overlooked opportunities.

**What You'll Do:**

In this role, you’ll have the opportunity to lead, identify and deliver innovative approaches to the diagnosis of respiratory patients. You’ll also:

- You will work in close partnership with the broader cross functional team to identify high priority collaboration with external partners, ensuring projects deliver tangible results in a compliant manner
- You will be able to build strong relationships with recognized national/international key external experts to understand where the greatest opportunities are to support respiratory patients
- Design and execute initiatives to drive clinical suspicion and screening among high-risk patients in multiple physician settings
- Develop and implement integratedtools tofacilitatepatient risk stratification and improve diagnostic efficiency in key national and regional lab systems
- Develop high-impact, channel-specific content for both HCPs and patients on the role oftimelydiagnosis, symptom recognition, etc.
- Define the key performance indicators and lead deep-dive analysis into regional variations, patient flowmodelingand related forecasting assumptions.
- Provide input into the integrated evidence generation planning effortsregardingthe value of early diagnosis

**Who You Are:**

You have a Bachelors Degree along with a minimum years of experience 10 years of experience inpharmaceutical or biotechmarketing,withat least 4 yearsininfectious disease, respiratory or rare disease.

You are or you also have:

- Demonstrated experience leading cross-functional teams,managing senior-levelstakeholdersand influencing strategy at the executive level
- Excellent communication skills and strong analytical skillsrequiredto understand scientific data, recognize key businessissuesand prepare high-level presentations for senior executives.
- Ability to shift thinking between the overall ‘big’ picture and thedetails
- Proventrack recordof success showing strong strategic thinking,problem-solvingand decision-making capabilities.
- Ability to lead and influence without authority cross-functionally and cross-culturally.
- Excellent learning capability and aspiration for excellence

**Where You’ll Work**

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

**Travel Requirements**

This role requires occasional travel (approximately 20%)

\#LI-TB1

\#LI-Remote

**Pay Range:**

$177,000.00-242,000.00 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.*

Associate Director, Commercial Forecasting, Respiratory

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 an Associate Director, Commercial Forecasting, Respiratory on the Commercial Effectiveness team to help us expand what's possible for patients with serious and rare respiratory diseases. Reporting to the Senior Director, Commercial Forecasting & Competitive Intelligence, you'll execute and maintain forecasts across respiratory indications — from modeling through to narrative creation — helping to shape commercial strategy for Insmed's respiratory portfolio. As a key partner to cross-functional stakeholders including Marketing, Sales, and FP&A, you'll optimize the estimation and articulation of the commercial opportunity across the respiratory therapeutic area.

**What You'll Do:**

In this role, you'll have the opportunity to be a core contributor to Insmed's commercial forecasting engine — building and maintaining models that inform critical business decisions across the respiratory portfolio.

You'll also:

- Develop and maintain forecasting models in Excel, with a primary focus on US forecasts across multiple respiratory products and indications
- Collaborate closely with regional Commercial Effectiveness teams to ensure consistency of respiratory forecast assumptions across countries and to ensure clear, aligned messaging
- Maintain an up-to-date view of key risks and opportunities across the short, mid, and long term
- Integrate secondary data analyses and primary market research insights to strengthen forecast assumptions for respiratory indications
- Partner with the Senior Director, Commercial Forecasting & Competitive Intelligence in the preparation and delivery of forecast narratives to senior leaders
- Collaborate with analytics teams to track respiratory product performance vs. forecast expectations
- Work closely with vendor partners to identify analogs and benchmarks relevant to the respiratory landscape
- Stay current on market evolutions and competitive dynamics in the respiratory space relevant to Insmed's products and pipeline

**Who You Are:**

You have a Bachelor's degree (MBA or advanced degree preferred), along with8+ years of experiencein commercial demand forecasting in pharmaceutical/biotech or healthcare consulting.

You are a detail-oriented, analytically rigorous contributor who can translate complex data into compelling narratives, and you also have:

- Knowledge of pharmaceutical data sources (e.g., sales, specialty pharmacy, payer, promotional & marketing data, longitudinal patient-level data)
- Experience with launches and commercialization of pharmaceutical products (respiratory launch experience a plus)
- Experience within the US market (global market experience a plus)
- Proficiency with secondary data sources, including APLD medical claims data, audited TRx data (IQVIA or Symphony Health), and epidemiology references relevant to respiratory conditions
- High proficiency in MS Office (Excel, PowerPoint)
- Experience with advanced analytical modeling
- A blend of technical proficiency and business acumen

You're an agile team player who can adapt and execute in an evolving environment. You lead without authority in cross-functional settings, listen actively, and communicate with clarity — both verbally and in writing.

**Where You'll Work**

This is a purposeful role. You'll have the option to work remotely most of the time, with in-person collaboration when it matters most.

**Travel Requirements**

This role may require occasional domestic travel based on business needs (10%).

\#LI-JT1

\#LI-Remote

**Pay Range:**

$155,000.00-201,500.00 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.*

Director, Competitive Intelligence

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:**

Insmed is seeking a strategic and analytically driven Director, Competitive Intelligence to join our Commercial Effectiveness team. In this high-impact role, you will shape how Insmed understands and responds to the evolving competitive landscape across our portfolio of assets in serious and rare diseases.

Reporting to the Senior Director, Commercial Forecasting and Competitive Intelligence, you will partner closely with Commercial Strategy, Marketing, and Market Access teams — and work in close collaboration with Insights Leads across therapeutic areas. Your work will deliver timely, actionable competitive insights that inform brand strategy, pipeline prioritization, and decision-making across Insmed's current and future assets.

The ideal candidate brings deep expertise in pharmaceutical competitive intelligence, strong commercial and scientific acumen, as well as a disciplined, hypothesis-driven approach to synthesizing complex market dynamics and implications. This is a hands-on, entrepreneurial role requiring the ability to lead projects end-to-end — from intelligence gathering and analysis through to storytelling and driving strategic action.

**What You'll Do:**

In this role, you'll have the opportunity tomanage and evolve the CI monitoring, synthesis, and communication of competitive developments, for both approved products and pipeline programs. You'll also:

- Collaborate closely with Insights Leads across therapeutic areas to ensure competitive intelligence is integrated with broader market insights and strategic planning efforts. Serve as a key connector between CI findings and insights-driven initiatives to maximize the impact of cross-functional intelligence work.

- Proactively identify key strategic questions and design intelligence frameworks that deliver actionable insights for global program teams through cross-functional collaboration.

- Partner with Commercial Strategy, Marketing, and Market Access to evaluate competitive threats and opportunities, inform lifecycle management decisions, and support asset prioritization.

- Translate data from scientific publications, conference presentations, earnings calls, regulatory filings, and primary research into clear, executive-ready competitive narratives.

- Establish key performance indicators for competitive monitoring and lead deep-dive analyses into market share dynamics and competitive forecasting assumptions.

- Build strong partnerships with US and regional partners to align competitive insights with commercial priorities and drive data-informed decision-making.

**Who You Are:**

You have a minimumBachelor's degreealong with8 years of minimum experienceinthe pharmaceutical or biotech industry (competitive intelligence, strategic consulting, market research, analytics, or business development), ora combination of education and relevant experience. You are or you have:

• Demonstrated success working with cross-functional teams and influencing senior-level stakeholders

• Excellent communication skills with the ability to translate complex competitive data into compelling, executive-ready narratives

• Strong analytical mindset with the ability to identify competitive threats and opportunities and develop intelligence plans that yield actionable insights

• Naturally curious with a drive to understand the "why" behind competitive moves and market trends — and the ability to synthesize findings into clear, concise stories

• Comfortable shifting between the big picture and granular details as business needs evolve

• Proven ability to lead and influence without direct authority

• Agile, collaborative team player who thrives in a fast-paced, evolving environment

- At least 4 years of experience in respiratory, specialty, or rare disease preferred

**Where You'll Work**

This is a fully remote role. You will have the flexibility to work from anywhere, with purposeful virtual collaboration across teams and occasional in-person engagement when it matters most.

**Travel Requirements**

This role requires occasionaltravel (approximately20%).

\#LI- JT1

\#LI-Remote

**Pay Range:**

$177,000.00-242,000.00 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.*

[*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.*

Novo Nordisk

Senior PM Project Manager - Virginia

**About the Department**

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

Our new Petersburg, Virginia site marks a strategic move to advance our capabilities in Emerging Technologies (ET) within Chemical API development and production. The highly experienced site is designed to strengthen and accelerate our Small Molecule (SMOL) strategy while amplifying our operational capacity. This is to safeguard and support ET´s SMOL projects in the coming years, aligning with our vision and strengthening our potential for growth and innovation.

What we offer you:

- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including 14 paid holidays
- Health Insurance, Dental Insurance, Vision Insurance – effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**The Position**

Responsible for complete Project Management (personnel & processes) for the site processes in the assigned area for a new facility/production line. Manages all aspects of the Project from conception through completion within scope, cost, quality & schedule requirements. Leads & manages the Project Management team so that stated project objectives & solution requirements are met in compliance with company procedures & standards.

**Relationships**

Reports to Associate Director or Site VP.

**Essential Functions**

- Responsible for defining overall scope, establishing detailed RFP for obtaining proposals from all required consultants (engineering, construction, cost estimations (IPC costs), equipment vendors, etc.)
- Ability to create detailed business case, & present to senior management within NN & IPG for funding of project
- Effectively organize & manage multi-disciplined project team to ensure successful completion of all project deliverables – including hiring, goal setting, performance management, employee development & engagement
- Manage major milestones, schedules & monthly cost plans through the Clarity & PEM processes
- Provide periodic project status to STC including risks/mitigations, financial updates, short/long term project outlook, etc
- Responsible for managing project change control to ensure project remains within defined scope, budget & schedule
- Extensive collaboration with other sites within NN & external stakeholders to gain best practices & equipment specifications
- Responsible for adherence to mechanisms for monitoring project progress, intervention & problem solving with other line managers or personnel
- Assist with any training required of personnel supporting the project
- Ensure all facets of the project lifecycle align with expectations set forth by the STG &/or project owner, such as installation, troubleshooting, qualification & validation of equipment
- Lead, & coach Subject Matter Experts (SMEs) to ensure a high performing collaborative team environment
- Follow all safety & environmental requirements in the performance of duties
- Other duties as assigned

**Physical Requirements**

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time (% can change on a case-by-case basis based on the role).

**Minimum Qualifications**

- Bachelor's Degree in Engineering/Economics/Business Administration or other relevant disciplines from an accredited university required and a minimum of nine (9) years proven leadership & project management in a manufacturing facility, including experience with: Capital Investment Projects with major projects in excess of $20M required
- Product/Process Transfer Projects required
- Change Management Projects required

**Preferred Qualifications**

- Advanced Project Management competencies obtained through relevant PM training or experience preferred
- Minimum of five (5) years of experience in pharmaceutical or biotechnology environment preferred
- Knowledgeable in core work processes & GMP concepts preferred
- Understanding of complicated product documentation & standard operating procedures with attention to high-level concepts preferred
- Demonstrates functional/business understanding as well as superior written & oral communication skills preferred
- Extensive knowledge of project management including the ability to create work plans & detailed project schedules preferred
- Proficient in problem solving, negotiation, conflict management & interpersonal skills preferred
- Ability to act as project lead & lead cross functional project teams in the development & implementation of projects preferred
- Ability to influence others on objectives & projects outcomes preferred
- Basic understanding of contractual documents preferred
- Ability to read/review design drawings (CAD) with a basic understanding of P&ID, HVAC & Electrical systems preferred
- Thorough understanding of technical documents such as URS, SAT, FAT & Validation Protocols preferred
- Proven project management experience with direct management of multiple projects simultaneously preferred
- Proven expertise in mentoring/development, planning/organizing, managing execution & revising the work plan for complex problems preferred
- Initiative & ability to function independently or within a team preferred
- Good judgment in decision making as well as good leadership skills preferred

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Virginia

Syner-G BioPharma Group

Consultant II, Regulatory Affairs Advertising and Promotion

**COMPANY DESCRIPTION:**

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video [**here**](<https://www.youtube.com/watch?v=2rUMvtncuw8>).

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

For more information, visit [www.Synergbiopharma.com](<https://www.synergbiopharma.com/>)

**POSITION OVERVIEW:**

This role is responsible for ensuring promotional communications are truthful, balanced, non-misleading, evidence-based, and consistent with approved product labeling, applicable FDA requirements, OPDP expectations, Health Canada regulations, and PAAB Code standards. The Consultant II serves as a key regulatory partner to Commercial, Medical, Legal, and Global Regulatory teams, enabling timely and compliant execution of brand strategy across product launch and lifecycle activities.

The position leads regulatory review and risk assessment activities for US and Canadian promotional materials directed to healthcare professionals, payers, patients, and other external stakeholders across traditional, digital, and omnichannel platforms. Success in this role requires strong regulatory expertise, sound judgment, and the ability to translate complex regulatory requirements into practical business guidance.

**WORK LOCATION:**

Travel to client sites may be required up to 10%, based on project demands and client expectations.

**KEY RESPONSIBILITIES:**

(This list is not exhaustive and may be supplemented and changed as necessary.)

- Oversee the preparation and submission of regulatory documents.
- Lead regulatory review and approval of US and Canadian promotional, advertising, disease awareness, training, congress, payer, market access, patient support, corporate communication, and digital materials for assigned products.
- Evaluate materials for consistency with approved labeling, scientific evidence, fair balance requirements, risk communication, comparative claims, appropriate audience targeting, and overall regulatory compliance.
- Conduct risk assessments and provide recommendations that support compliant and effective stakeholder communications.
- Ensure promotional communications are supported by appropriate evidence and aligned with applicable regulatory and industry standards.
- Serve as the Regulatory Affairs representative on promotional review committees.
- Collaborate with Medical Affairs, Legal, Commercial, Market Access, Corporate Affairs, Pharmacovigilance, and Compliance partners to facilitate timely review and approval of materials.
- Partner with internal stakeholders and external agencies to resolve regulatory comments and ensure alignment on promotional strategy.
- Represent Regulatory Affairs in interactions with alliance partners and global teams.
- Provide strategic guidance regarding FDA and OPDP requirements for prescription drug advertising, promotional labeling, product claims, risk communication, and submission readiness.
- Advise teams on Health Canada advertising requirements, PAAB standards, and Canadian promotional review expectations.
- Support promotional strategy for product launches, lifecycle management activities, label changes, and new indications.
- Provide guidance on claim development, evidence generation strategies, competitive positioning, and use of clinical, real-world, and health economic evidence in promotional materials.
- Support PAAB submissions, responses, and approval strategies for Canadian promotional materials.
- Collaborate with internal stakeholders and external agencies to address PAAB feedback, develop supporting references, revise claims, and achieve timely approvals.
- Ensure healthcare professional-directed materials meet PAAB preclearance requirements and industry standards.
- Monitor FDA, OPDP, Health Canada, PAAB, and industry developments, including enforcement trends, guidance updates, and evolving regulatory expectations.
- Communicate regulatory changes and business implications to key stakeholders.
- Develop and deliver training programs, job aids, and best practices to strengthen promotional compliance and review quality.
- Support continuous improvement initiatives related to review workflows, documentation standards, governance processes, escalation pathways, and inspection/audit readiness.

**QUALIFICATIONS AND REQUIREMENTS:**

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

*Education*

- Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline required.
- Advanced degree preferred.

*Technical Experience*:

- Minimum 3-5 years of experience within the pharmaceutical, biotechnology, biologics, biosimilars, regulatory, or health authority environment.
- Significant experience in advertising and promotional regulatory review.
- Experience participating in multidisciplinary Medical/Legal/Regulatory (MLR) review processes.
- Demonstrated ability to influence cross-functional teams while maintaining regulatory integrity.

*Knowledge, Skills, and Abilities*:

- Strong knowledge of FDA promotional requirements and OPDP expectations governing prescription drug advertising and promotional labeling.
- Strong understanding of Health Canada advertising requirements, PAAB Code standards, and the Canadian preclearance process.
- Ability to evaluate clinical evidence, product labeling, safety information, comparative claims, real-world evidence, and market access messaging for promotional compliance.
- Knowledge of fair balance principles, risk communication requirements, claim substantiation, and evidence-based promotional practices.
- Strong project management, prioritization, and decision-making capabilities.
- Excellent written and verbal communication skills with the ability to provide practical, solution-oriented regulatory guidance to senior stakeholders.

*Preferred Qualifications*

- Experience supporting both US and Canadian promotional review activities for prescription drugs, biologics, or biosimilars.
- Direct experience with OPDP advisory submissions, FDA promotional correspondence, PAAB submissions, and Canadian preclearance review processes.
- Experience supporting product launches, new indications, label updates, digital campaigns, congress materials, omnichannel initiatives, and competitive response strategies.
- Familiarity with electronic promotional review systems, document management platforms, reference management tools, and audit-ready documentation practices.
- Experience mentoring or providing guidance to junior regulatory professionals.

**ESSENTIAL FUNCTIONS:**

*Physical Demands*:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

*Work Environment*:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

**TOTAL REWARDS PROGRAM:**

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.

**LEGAL STATEMENT:**

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

Eli Lilly and Company

Associate Director, R&D Communications -Cardiometabolic Health

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Company Overview:**

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We are looking for people who are determined to make life better for people around the world.

**Responsibilities:**

The Associate Director, R&D Cardiometabolic Health Communications is the dedicated communications lead for Lilly's cardiometabolic health pipeline, accountable for core deliverables: data congress strategy and milestone data communications. This role is embedded with LRL counterparts in cardiometabolic health and maintains a dotted-line relationship with the Cardiometabolic Health TA communications lead. Lilly's cardiometabolic portfolio is one of the most expansive in the industry, spanning incretins, cardiovascular disease, metabolic dysfunction-associated steatohepatitis (MASH), and related conditions. This therapeutic area sits at the center of Lilly's growth story and public narrative. Reporting to the Senior Director, Global Data Storytelling Communications, the Associate Director leads communications across the scientific lifecycle for cardiometabolic health assets, from pre-clinical through first regulatory approval, ensuring every data moment is strategically planned, narratively connected to the enterprise science story, and executed with the quality and ambition that reflects Lilly's position as the world's most valuable healthcare company. This is a trusted advisor to senior R&D and TA leaders.

**Specific responsibilities include**:

- DATA COMMUNICATIONS AND NARRATIVE STRATEGY: Develop and own the early, mid- and late-stage communications strategy and positioning for the cardiometabolic health pipeline. Architect narratives before milestones land, ensuring Lilly shapes how the science is understood rather than reacting to it. Connect every data readout to the broader Lilly enterprise science story.
- CONGRESS STRATEGY: Follow early Congress playbooks to show up with Lilly’s CMH data where and how it matters.
  PUBLICATIONS STRATEGY: Partner with medical affairs and R&D to align publications strategy with communications objectives. Ensure peer-reviewed data disclosures reinforce the corporate narrative and are supported by proactive media and stakeholder engagement.
- EXECUTIVE COMMUNICATIONS AND COUNSEL: Serve as a trusted advisor to senior cardiometabolic health R&D and TA leaders. Prepare executives for media interviews, scientific congresses, and other high-stakes engagements. Develop executive visibility strategies and supporting materials.
- MEDIA RELATIONS: Develop and execute proactive media strategy for cardiometabolic health pipeline milestones. Build and maintain relationships with key journalists covering the therapeutic area. Manage reactive media inquiries in partnership with the broader media relations team.
- CROSS-TA AND ENTERPRISE INTEGRATION: Partner with fellow TA leads, the Emerging and Portfolio Science team, and the Global Consumer Science Communications and Scientific Storytelling Communications pillars to ensure narratives are integrated. Contribute to the enterprise data release playbook and unified congress presence.
- ISSUES MANAGEMENT: Develop messaging frameworks, scenario plans, and rapid-response protocols for competitive and reputational issues specific to the therapeutic area. Serve as a trusted expert for issues navigation within the communications function.
- TEAM COLLABORATION: Partner across communications to execute plans. Manage agency partners and external resources effectively.

**Basic Qualifications**

- Bachelor's degree in communications, science, public relations, or related field
- Minimum 5 years of communications experience in pharmaceutical, biotech, or healthcare environments
- Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

**Additional Skills/Preferences**

- Strong understanding of the cardiometabolic landscape, including GLP-1 receptor agonists, obesity, Type 2 diabetes, cardiovascular outcomes, and MASH. Familiarity with the competitive dynamics in this rapidly evolving space.

- Demonstrated experience in cardiometabolic health or closely related therapeutic area communications
- Proven experience with clinical data communications, congress strategy, and media relations
- Experience providing strategic communications counsel to senior executives

- Exceptional ability to translate complex scientific and clinical data into compelling narratives for diverse audiences, including media, investors, policymakers, and patients
- Demonstrated ability to architect proactive narratives around data milestones rather than responding reactively
- Strong media relations skills with experience engaging top-tier science, health, and business journalists
- Experience with publication planning and medical affairs collaboration
- Proven judgment in high-pressure situations with significant reputational implications
- Proactive, anticipatory mindset with the discipline to prepare for emerging issues and competitive dynamics
- Track record of communications work that drove measurable business outcomes
- Strong executive presence and credibility with senior stakeholders across R&D, commercial, and corporate functions

**Additional Information**

• Location: Indianapolis, IN.

• Domestic and international travel expected (15-25%).

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$127,500 - $187,000

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Indiana

Senior Director, Global Parenteral Drug Product Technical Services (MSAT)

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Position Brand Description:**

This is a senior leadership role within our Global Parenteral Drug Product Technical Services and Manufacturing Science (MSAT) organization. You will be accountable for ensuring that qualified resources, robust systems, and effective governance are in place to provide technical stewardship of commercial parenteral drug product processes across our entire manufacturing network – spanning both internal sites and external contract manufacturing partners.

As the leader of our Global Product Stewards for our portfolio of parenteral drug products, you will set the technical direction for how we sustain, optimize, and defend the processes behind some of the world’s highest-volume and most complex injectable medicines. Your organization will be a key connector across the network: the team that manufacturing sites turn to when critical technical questions arise, and the team that ensures consistency, compliance, and continuous improvement at a global scale.

This is a high-impact, high-visibility position for a leader who thrives on operating across organizational boundaries and building the technical capability of a world-class parenteral manufacturing network during a period of significant growth and expansion.

**Key Objectives and Deliverables:**

- Lead the Global Product Steward organization for parenteral drug products, setting strategic priorities and directing technical oversight for the full portfolio of commercial injectable products and active technical transfer programs across the manufacturing network.
- Serve as the network-level point of contact and escalation path for complex technical issues in parenteral drug product manufacturing, making real-time decisions that support production continuity across multiple manufacturing sites and geographies.
- Build, develop, and retain a high-performing team of Global Product Stewards – the subject matter experts who own process knowledge, drive lifecycle management, and provide hands-on technical support for parenteral drug products across the network.
- Ensure the organization is staffed with appropriately trained and qualified technical experts to deliver network-level stewardship, execute the parenteral technical agenda, and support capacity expansion as new sites and presentations come online.
- Represent the Technical Services / MSAT organization in cross-functional governance forums, bringing a network-wide perspective to decisions on process changes, site readiness, regulatory strategy, and capital investment.
- Facilitate Parenteral Technical Leadership Network meetings, creating the forum where site-level technical leaders align on standards, share lessons learned, and make coordinated decisions across the network.
- Drive network-wide consistency and continuous improvement by building strong, trust-based relationships with manufacturing site leadership teams and influencing technical strategy at both the site and global level.
- Champion a culture of safety across the organization, leading initiatives and ensuring compliance with all corporate and site-level health, safety, and environmental goals.
- Design and implement recognition and reward programs that reinforce a culture of technical excellence, collaboration, and accountability across a geographically distributed team.

**Minimum Requirements:**

- Bachelor’s degree or higher in a science, engineering, or technical discipline (e.g., Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or related field).
- 15+ years of experience in pharmaceutical manufacturing within a current Good Manufacturing Practice (cGMP) environment.
- 10+ years of direct experience in parenteral (injectable) drug product manufacturing, with significant depth in technical services, MSAT, process support, manufacturing science, or process engineering roles.
- Demonstrated track record of leading technical organizations or functions that operate across multiple manufacturing sites, with experience influencing outcomes in a matrixed, global environment.

**Additional Preferences:**

- Experience leading through periods of network expansion – such as new site startups, major technology transfers, or the addition of new dosage forms and presentations to an existing parenteral drug product network.
- Proven ability to set priorities and allocate resources across a global portfolio with competing demands, balancing short-term operational needs against long-term strategic objectives.
- Strong executive communication skills, with the ability to distill complex technical topics for senior leadership, regulatory agencies, and cross-functional partners.
- A track record of building productive partnerships across organizational, functional, and geographic boundaries – particularly in environments where influence matters more than direct authority.
- Experience engaging with global health authorities (e.g., FDA, EMA, PMDA) during regulatory inspections and lifecycle submissions for parenteral drug products.
- Deep familiarity with technology transfer, process validation, and lifecycle management for injectable drug products.
- A commitment to fostering a safe, inclusive, and continuously improving work environment.

**Other Information:**

- Standard work schedule is Monday through Friday during regular business hours.
- Flexibility is expected - you may occasionally need to be available outside standard hours to respond to urgent technical issues if they arise across the global network.
- Some domestic and international travel will be required (up to approximately 25%).
- This is an on-site position, with work from home flexibility up to 2-4 days per month; remote work is not available for this role.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$163,500 - $239,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Sr. Advisor - AI/ML Product Owner

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Organization Summary**

The CMC Portfolio Analytics & Insights (PAI) team is an integral part of CMC Project Management within Lilly Research Laboratories’ Product Research and Development organization. The CMC Project Management team is responsible for leading the design and execution of integrated CMC strategies from portfolio entry through global submissions and approvals.

The PAI is a newly established, strategic team dedicated to leveraging data analytics to transform CMC project management. This team will transform CMC portfolio data into a strategic asset for decision-making—tracking PRD portfolio metrics, driving PM tool development, and setting data standards. As a key enabler for data-driven decision making, this team has significant opportunities to create substantial impact by providing actionable insights, optimizing portfolio performance, and supporting strategic initiatives across our CMC operations. Join us at this pivotal moment and play a key role in shaping the future of CMC project management.

**Position Summary**

We are seeking a highly motivated and skilled AI/ML Product Owner to join our CMC Portfolio Analytics & Insights Team. As a Sr. Advisor - AI/ML Product Owner, you will lead the product strategy, roadmap, and delivery of innovative AI/ML-driven solutions that transform our pharmaceutical processes and accelerate drug discovery and development. You will bridge the gap between business needs and technical execution, ensuring the successful realization of high-impact AI/ML products.

**Responsibilities**

**Data Product Ownership**

- Own the CMC Operational Data Product end-to-end — definitions, data contracts, quality standards, and lifecycle.
- Partner with the Data Foundation workstream to enforce naming and field standards, automate pipelines, and eliminate manual reconciliation across PRD.
- Define and track data-product health KPIs (freshness, completeness, lineage, adoption) and report on them.
- Make and document the governance decisions that keep the product trustworthy — which source becomes the authoritative record, which duplicate reports and trackers are retired, and how changes are communicated to users.

**AI/ML Architecture**

- Design and build the AI interactive layer on top of the governed Data Hub and Power BI semantic model, engineering it so agent queries execute under the requesting user's authenticated identity.
- Build the AI accuracy/validation framework needed to move capability from today's “AI mindset” (data prep, summarization, pattern-spotting, always human-owned) to tomorrow's core capability (predictive risk models, early-warning signals, ask-the-portfolio).
- Prototype and iterate AI capability against real use cases already in flight, and report accuracy against validated outcomes.

**Hands-On Technical Build**

- Independently architect and build core components — pipelines, semantic-model extensions, AI/agent interfaces — this is a working architect role, not a pure oversight role.
- Set technical standards, review practices, and reusable architecture patterns that the wider data engineering and analytics/visualization functions build against.

**Cross-Team Leadership, AI Storytelling & IT Partnership**

- Turn technical AI and data work into compelling stories — translate pipelines, model behavior, and architecture decisions into narratives that make AI capability tangible, credible, and easy to back for non-technical leadership.
- Act as a constructive challenger of the status quo — question legacy manual processes, parallel trackers, and entrenched ways of working, and make the case for change even when it's uncomfortable or meets resistance.
- Coordinate day-to-day with the Data Engineer and Insights Lead on the PAI team so the AI layer stays aligned with the data foundation and the insights being surfaced.
- Partner directly with IT/Tech@Lilly to take the Data Hub and AI layer from MVP to enterprise-grade.

**Stakeholder Engagement & Governance**

- Represent the team's AI and data architecture in cross-functional governance forums and on a cross-functional data and AI advisory board.
- Translate technical architecture and AI capability into a business narrative.
- Provide credible technical grounding for roadmap and leadership review materials.
- Ensure compliance with all relevant industry regulations, data privacy standards, and company policies.

**Basic Requirements**

- Ph.D. or Master’s degree preferred or Bachelor’s degree required in Computer Science, Engineering, Data Science, Bioinformatics, or a related quantitative field with the following years of relevant experience: PhD with 6+ years, Master’s with 9+ years or Bachelor’s with 12+ years.
- 8–10+ years’ experience building production data and AI/ML architectures
- Proven track record of successfully defining, launching, and scaling AI/ML-powered products from conception to widespread adoption.
- Strong understanding of various machine learning algorithms, deep learning techniques, natural language processing (NLP), and computer vision.
- Experience with AI/ML platforms, tools, and cloud services (e.g., AWS SageMaker, Google AI Platform, Azure ML).
- Demonstrated ability to translate complex technical concepts into business terms and effectively communicate with both technical and non-technical stakeholders.
- Excellent analytical, problem-solving, and decision-making skills.
- Demonstrated willingness to challenge existing processes, tools, or decisions and drive change without waiting for formal authority to do so.
- Strong stakeholder communication skills and comfort presenting technical tradeoffs to senior and executive leadership.
- Experience partnering with IT/enterprise infrastructure teams to move a solution from pilot or MVP into supportable, production-grade scale — cloud hosting, security review, and ongoing operations.
- Experience with data governance, MLOps, and responsible AI practices.

**Preferred Qualifications**

- 3–5 years’ experience designing solutions on governed enterprise data — row-level security, identity-based access control, and semantic modeling.
- Strong leadership, interpersonal, and communication skills, with the ability to influence and inspire cross-functional teams.
- Experience working in an agile development environment (Scrum, Kanban).
- Familiarity with the pharmaceutical industry, drug discovery, clinical development, or life sciences research is highly desirable.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$144,000 - $231,000

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Associate Director; External Supply Chain, Clinical Drug Product

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Overview:**

At Lilly, we serve an extraordinary purpose. For nearly 150 years we have worked tirelessly to discover medicines that make life better. In Product Research and Development (PRD), we transform molecules into medicines, advancing one of the most diverse and promising pipelines in the industry.

PRD’s External Supply Chain & Operations (ESCO) team stewards PRD's external partner network — delivering supplier excellence, systematic and scalable sourcing workflows, supply chain design, technical-transfer processes, and end-to-end network performance across drug substance, drug product, and analytical services.

This role is responsible for sourcing clinical (Phase 1–3) drug product manufacturing capacity across the PRD portfolio, with a primary focus on parenteral manufacturing and a supporting focus on solid oral manufacturing.

The role serves as the connective link between CM&C (Chemistry, Manufacturing & Controls) teams, who define project manufacturing needs, and the network of contract manufacturing organizations (CMOs) that supply that capacity — managing the sourcing lifecycle from needs assessment through vendor recommendation and ongoing vendor relationship management.

**Key Responsibilities**

**End-to-End Clinical Drug Product Sourcing**

- Partner with Clinical GMP DP supply group and CM&C teams to assess clinical drug product manufacturing needs and match those needs against Lilly's portfolio of contract manufacturing partners, based on capability, capacity, and modality fit, including assessment of internal manufacturing capacity where applicable.
- Lead Drug Product RFP authoring working with technical subject matter experts across PRD (CM&C, CSD, BRD, and SMDD); partner with Procurement on sourcing process and evaluation of proposals.
- Serve as the DP Supply Chain resource for external CMOs during the sourcing process.
- Lead review of proposals and generate external sourcing recommendations in partnership with program team, functional leadership, and Procurement.

**Supply Chain Operations**

- Contribute to and help ensure network-wide adherence to PRD Drug Product guidance documentation and standards, including RFx, Due Diligence, Technical Transfer, and CMO Operational KPIs.
- Continuously assess the drug product manufacturing partner portfolio against current and forecasted PRD needs to identify gaps or emerging risk, leveraging dedicated sourcing intake tools and follow-up with CM&C project teams.
- Partner with Procurement to identify, RFI, and shortlist new manufacturing partners where portfolio gaps exist, and lead due diligence teams — including on-site visits — to assess candidate providers.
- Support the PRD DP Platform Strategies by filtering new vendor needs against established platform guidance where available, applying independent judgment where platform strategy has not yet been defined for a given drug product platform.
- Proactively track emerging manufacturing trends (new modalities, container closure systems, manufacturing technologies) to anticipate capability needs ahead of clinical demand.
- Support Phase 3 transition planning with Strategic Facilities Planning (SFP) to place projects with suppliers appropriate for eventual transition to Commercial Manufacturing.

**Vendor Relationship Management & Performance**

- Serve as Alliance Manager for key Drug Product CMOs tiered as Critical or Leverage within the PRD Supplier Governance framework, in close partnership with Clinical Trial (CT) Manufacturing management, building strong, collaborative partnerships with contract manufacturers.
- Monitor and manage vendor performance metrics and communicate performance scorecards and business reviews with third-party manufacturing partners to support continued improvement and future sourcing decisions.
- Serve as a key point of contact for issue escalation and resolution with manufacturing partners, applying strong cross-cultural and cross-functional communication skills across national and organizational cultures.

**Digital Sourcing Systems & Data Stewardship**

- Partner on the design, administration, and continuous improvement of digital sourcing and tracking systems used to manage clinical drug product manufacturing demand, capacity, and vendor performance data.
- Contribute vendor capability, capacity, and performance data toward a unified, centralized supplier tracking and capability database for the External Supply Chain & Operations network.
- Support the evaluation and adoption of emerging AI-enabled sourcing tools that improve partner-capability, capacity, and performance decision-making across the network.

**Basic Qualifications**

- BS or MS in Pharmaceutics, Pharmacy, Formulation Science, Chemical Engineering, Pharmaceutical Sciences, or closely related STEM discipline required.
- BS graduates must have at least 8 years of relevant experience in pharmaceutical drug product R&D, GMP drug product manufacturing, and/or drug product supply chain.
- MS graduates must have at least 6 years of relevant experience in pharmaceutical drug product R&D, GMP drug product manufacturing, and/or drug product supply chain.
- Parenteral drug product manufacturing experience required.

**Additional Preferences**

- Demonstrated experience managing external CMO relationships and working knowledge of clinical (Phase 1–3) drug product manufacturing and related CMC, Quality, Regulatory, and HSE requirements.
- Strong vendor relationship management, negotiation, and conflict-resolution skills; ability to communicate effectively across cultures and organizational levels, in both written and verbal formats.
- Experience leading supplier due diligence and qualification efforts, including on-site assessments.
- Ability to operate effectively in ambiguity, manage competing priorities, and adjust quickly to change.

**Additional information**

- Travel: 10 to 20%.
- Position Local: Indianapolis, IN; Lilly Technology Center-North (LTC-N). This is an on-site position.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$117,000 - $171,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Advisor - Project Statistician in Product Development

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Brand Description:**

Lilly Research Laboratories (LRL) aims to discover and develop novel medicines that will benefit patients globally through a relentless focus on innovation and solutions to unmet needs. We are looking for a highly qualified statistician to support a wide variety of projects in the product development (nonclinical) area of LRL in collaboration with biologists, chemists, formulators, and engineers. In addition to strong technical skills, the role requires a strong desire and ability to take initiative, educate, and communicate the value of good statistical practices and concepts to a variety of fellow scientists.

**Location**: Indianapolis

**Key Objectives/Deliverables:**

The statistician will provide statistical support to scientists in Product Development with a mix of emphasis on a variety of molecule types, including new modalities.

- Experimental design and analysis support for chemists/biologists and formulation scientists to develop & optimize chemical/biochemical processes as well as oral and parenteral formulations, in both batch and continuous manufacturing
- Experimental design and analysis support for analytical chemists to develop, validate, and transfer analytical methods
- Design and analysis of long-term and accelerated stability studies to inform development of clinical phase and commercial specifications and expiry dating
- Development and implementation of novel methods to enable or advance drug development and manufacturing
- Author sections of CMC (Chemistry, Manufacturing, and Controls) regulatory submission documents for successful product approval throughout the world
- Collaborate with scientists and statisticians on applied research projects related to modeling, experimental design, process control, and/or multivariate analysis.

Communication

- Collaborate with team members or external partners to communicate development study results with an emphasis on clarity and visualization
- Assist with or be responsible for communicating via manuscript or oral presentation
- Communicate results in one-on-one meetings with key customers or external partners and present at scientific meetings

Therapeutic/Scientific Area Knowledge

- Develop understanding of scientific areas and disease states to enhance the level of customer focus and collaboration and be a strong scientific contributor.

Regulatory Compliance

- Perform work in full compliance with assigned curricula and follow applicable Corporate, local, and departmental policies, procedures, processes, and training.

Training and Development

- Develop and provide training courses for various statistical methods

**Requirements:**

- Ph.D. in Statistics, Biostatistics, Industrial Engineering, Operations Research, or related field
  or
  M.S. in Statistics, Biostatistics, Industrial Engineering, Operations Research, or related field with at least 8 years relevant experience

**Additional Skills/Preferences:**

- Additional work experience, especially in the application of statistics in the pharmaceutical development or manufacturing areas
- Excellent English communication skills, especially related to technical/scientific issues
- Proficient in R, Python, JMP and/or SAS programming language.
- Proficient in acquiring and compiling data across sources
- Expertise in DOE, Bayesian, machine learning, visualization
- Interpersonal/teamwork and communications skills for effective customer collaboration
- Strong teamwork and leadership skills
- Self-management skills, creativity, and innovation
- Demonstrated problem solving ability and strategic thinking
- Degree in or strong desire to learn about chemistry, biology, engineering, computer science, and pharmaceutical science

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$153,000 - $246,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Advisor Engineer, Drug Product and Spray Drying Process Development - SMDD

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Position Brand Description:**

The Synthetic Molecule Design and Development (SMDD) department within Lilly Research Labs is involved in key activities for the advancement of small molecules, peptides, and oligonucleotides from early discovery phases to commercialization. Our scientists and engineers develop innovative technical and business solutions across a portfolio of projects using their deep technical expertise to accelerate testing of clinical hypothesis and overall drug development. Through recognizing the value of a hardworking, diverse, and inclusive workforce, SMDD delivers on these responsibilities and helps bring the next generation of life-changing medicines to patients. Our team is seeking a highly motivated candidate to work on drug product process development, with a focus on amorphous solid dispersion manufacturing technologies such as spray drying and related particle engineering platforms, spanning Phase 2/3 clinical trials through registration and commercialization.

**Responsibilities:**

Candidates must possess a strong background in chemical engineering fundamentals, including heat and mass transfer, particle formation, and process scale-up, and be able to integrate this understanding with analytical and manufacturing considerations to advance drug product manufacturing processes. Specific responsibilities for this role include:

- Apply engineering fundamentals to design, scale up, and optimize amorphous solid dispersion (ASD) manufacturing processes, such as spray drying, hot melt extrusion, and/or coprecipitation, for producing drug product intermediates from lab and pilot scale through commercial manufacturing scale.
- Drive process development activities for drug product intermediates advancing toward commercialization, translating process and analytical understanding into a robust, scalable control strategy that supports commercial manufacturing readiness and regulatory filing.
- Support technology transfer and scale-up of manufacturing processes to internal and external sites.
- Collaborate and communicate project specific challenges and opportunities with key partners, including external contract manufacturing organizations, to plan and manage short- and long-term development activities aligned with the global CMC strategy.
- Engage and influence internal and external scientific communities to solve technical challenges, identify and implement novel drug product manufacturing technologies, and inform process and control strategy decisions.
- Author and review high-quality technical reports, peer reviewed publications, and regulatory documentation to support new technologies and regulatory submissions.

**Basic Requirements:**

- Ph.D. in Chemical Engineering, Pharmaceutical Sciences, or closely related STEM degree with 0-5 years of demonstrated experience in pharmaceutical process development, or
- M.S. in Chemical Engineering, Chemical Engineering, Pharmaceutical Sciences, or closely related STEM degree with 7+ years of demonstrated experience in pharmaceutical process development, or
- B.S. in Chemical Engineering, Chemical Engineering, Pharmaceutical Sciences, or closely related STEM degree with 10+ years of demonstrated experience in pharmaceutical process development.

**Additional Skills/Preferences:**

- Experience with process development and scale-up of particle engineering and/or amorphous solids manufacturing technologies (e.g., spray drying process, hot melt extrusion, co-precipitation, etc.).
- Experience in technical considerations for equipment design and integration, process monitoring, integration of process analytical technology (PAT) systems, and scientific approaches to control strategy. Involvement with process modelling and simulation programs for improved process and formulation understanding.
- Experience with technology transfer to external manufacturing partners and cross-site process comparability.
- Experience supervising or guiding the work of other engineers or scientists.
- Excellent oral communication and documentation skills.
- Demonstrate ability to effectively collaborate with multidisciplinary teams.
- Demonstrate leadership behaviors with ability to accept challenges, seek opportunities to remove barriers, influence without authority, and lead in areas of uncertainty

**Additional Information:**

- Possible exposure to chemicals, allergens, and loud noises.
- Travel: 0 to 10%
- Position Local: Onsite Monday through Friday, Indianapolis, IN; Lilly Technology Center-North (LTC-N)

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$129,000 - $209,000

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Software Product Engineering - Development Lead - Silicon Valley Hub

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Technology continues to transform every aspect of society, including healthcare. Lilly envisions digital capabilities as an extension of our medicines, not just a marketing tactic. We, as consumers, have come to expect digital experiences to augment and support our experiences with medicines – especially to help reduce the burden of coping and managing through chronic disease for us, our loved ones and health care providers. Hence, Lilly’s Software Product Engineering team is committed to exploring how the next generation therapeutic ecosystems, connected solutions, and data analytics can transform the customer (patients, health care providers and payers) experience, demonstrate value, and most importantly – improve patient outcomes.

The SPE Development Lead will be responsible for developing and leading technical solutions supporting one or more Digital Health platforms. You will need to engage multiple teams to define technical requirements, develop designs, and align technology that enables the platform architecture all while meeting medical device regulatory expectations. Additionally, the organization will look to you to be a leader across SPE projects influencing other tech leads in how we develop platform solutions following best practices and driving our platform innovation roadmap.

**What You'll Be Doing:**

- Develop and drive adoption of platform development standards and architecture patterns across your team(s)
- Enable technical delivery of SPE software components including understanding and addressing risk, privacy, cybersecurity and legal constraints on project delivery
- Drive design of new feature requests that are highly scalable and resilient.
- Align SPE technical solutions with Lilly supported technologies
- Provide technical evaluation of proposed project ideas, software changes and future product releases.
- Drive the development and execution of our platform innovation roadmap, including creating working proof of concept models in new technology spaces directly connected to future Software Product Engineering capabilities
- Mentor more junior members of the development team
- Build effective relationships with key technical resources and architects to influence technology solutions specifically related to Software Product Engineering systems.
- Provide guidance to Lilly and non-Lilly software delivery teams in best practice Agile delivery of software components of Lilly’s platform
- Obtain and use knowledge of medical device delivery models and quality system to ensure solutions align with regulatory expectations and meet regulatory timelines
- Obtain and bring to bear knowledge of Lilly business processes and technology to ensure solution deliveries are consistent with the strategy and roadmap

**Your Basic Requirements:**

- Bachelor’s Degree in computer science, engineering, or related technical field
- 7+ years of experience delivering software solutions that span the development lifecycle, e.g., design, development, testing, deployment, and support
- 5+ years of technical leadership experience in delivery of software projects

**What You Should Bring:**

- Ability to manage and keep control of multiple software development and integration efforts.
- Demonstrable examples of leading software design and architecture
- Demonstrated ability to propose new ideas and influence peers
- Proven initiative to learn new technologies and seek opportunities utilize what you’ve learned
- Practical knowledge of Agile software development concepts and associated implementations.
- Experience with architected asynchronous systems, utilizing tools like Kafka or similar.
- Experience with AWS, Azure, and other cloud service providers
- Experience with identity management or authentication providers (preferably Okta)
- Experience with GitHub
- Experience with CI/CD capabilities and industry best practices
- Experience utilizing Atlassian (Jira/Confluence) or similar toolsets
- High level of intellectual curiosity, external perspective, and innovation interest

**Additional information:**

- Role is located in San Francisco, CA with a hybrid work model - relocation required

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$138,000 - $246,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Director, Process Engineer - Parenteral Drug Product Development

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Overview:**

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

**Position Summary:**

The Lilly Bioproduct Research and Development (BR&D) organization focuses on the development and commercialization of parenteral drug products of various modalities spanning from small molecules, peptides, oligopeptides, bioconjugates, proteins, vaccines to monoclonal antibodies, etc. The organization is also committed to the development of genetic medicines which includes active investments in AAV, LVV, mRNA, nanomedicines for tissue specific targeting and other gene delivery strategies. The drug product team is also investing in building new technology capability to support complex drug product commercialization in different drug product presentations such as co-formulation, high concentration, and long-acting presentations, etc. in different devices as the combination products.

We are seeking a highly motivated process engineer leader with extensive industry experience and knowledge in parenteral drug product process development from compounding to fill/finish to advance Lilly portfolio from clinical to commercialization. This position is located at Lilly’s tech center, next to Lilly’s headquarter in Indianapolis. This position seeks a candidate with extensive industry experience in process development. This candidate would drive cross-functional collaboration with Lilly internal and external key stakeholders to advance portfolio assets. If you are interested in developing novel medicine to serve millions and millions of patients, you should consider joining our diverse and high-performing team.

**Responsibilities:**

- Lead talented scientists to design and execute complex process studies to define clinical and commercial manufacturing process for various parenteral drug products. Mentor scientists to improve their scientific understanding in study design capabilities.
- Lead the efforts to design the process development and characterization of various new modalities, especially novel drug product presentations for late-stage process development, including assessing and mitigating process risks during scale-up via a deep understanding of in-process and final product critical quality attributes and critical process parameters.
- Drive collaboration with Lilly’s internal and external key stakeholders to address complex tech transfer challenges across sites, including both internal and external manufacturing organizations, and work closely with stakeholders to ensure the integration of novel excipients and technologies into CMC development timeline and appropriate pathway for regulatory submission.
- Drive collaboration with clinical manufacturing team to support clinical manufacturing at internal and/or external CMOs. Author and review tech transfer related documents and review batch records to ensure accuracy of the manufacturing steps and process parameters. Provide onsite technical oversight of clinical manufacturing to address any technical hurdles during manufacturing.
- Ensure consistency in technical deliverables and documentation across transfers.
- Cross-Functional Collaboration: Represent BRD organization on project teams. Partner with cross-functional stakeholders including but not limited to project management, analytical development, quality, device delivery, supply chain, internal/external manufacturing, tech/manufacturing service to define drug product and CMC timeline along with key deliverables to meet the requirements for regulatory submission.
- External Engagement: Establish and leverage strategic relationships with academic and industry partners to adopt new process technologies to accelerate product development.
- Innovation: Initiate and drive innovation to tackle complex new modalities process performance and product quality for various new modalities as well as new technologies. Actively involve and contribute to BRD and cross-functional innovation to support PRD strategy decision. Present scientific findings and present to internal and external stakeholders and leverage the innovations to advance Lilly portfolio.

**Basic Requirements:**

- Ph.D. in Chemical Engineering, Biomedical Engineering, or Pharmaceutical Sciences are highly preferred with a minimum of 7 years of industry experience directly in parenteral drug product process development from bulk drug product compounding to fill/finish.
- Extensive experience and knowledge with process development of parenteral drug products such as peptides, ADCs, fusion proteins, mAbs and vaccines manufacturing process is required.
- Large scale process development experience from clinical to commercialization is required.
- Hands-on experience in designing and optimizing manufacturing processes including large scale compounding, filtration and fill/finish is required.
- Strong knowledge and experience with regulatory submissions (INDs, NDAs and/or BLAs of parenteral drug products is required.
- Strong understanding of cGMP requirements, ICH and regulatory guidelines is a must.

**Additional Information:**

**Physical Demands/Travel:**

The physical demands of this job are consistent with a lab environment.

*The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.*

**Work Environment:**

This position’s work environment is in a laboratory environment.

*The* *work* *environment* *characteristics* *described* *here* *are* *representative of those an employee encounters while performing the essential functions of this job.*

*\*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.*

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$151,500 - $239,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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