Manufacturing & Production

AbbVie

Senior Medical Director - Patient Safety

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

The Product Safety Team (PST) lead for late stage oncology products, under the direction of the Group Lead and TA Head will be actively and closely collaborating with the development medical lead, setting the strategy for the oncology programs. PST lead will be responsible to one or more products and will ensuring safety through the product lifecycle (e.g. surveillance, signal detection, validation and assessment, risks assessment and mitigations strategies, tox management, etc…) together with the other members of the safety team (safety scientists, safety architects, safety PM, and other cross functional colleagues). The PST lead will also closely collaborate with a PK and toxicology leads, regulatory and clinical development leads as well as medical affairs colleagues to help guide dose selection and regimen, inclusion/exclusion criteria and safety monitoring for first for clinical trials as well as PMOS.PST lead will be interpreting regulations related to pharmacovigilance supporting all patient safety activities, and will be leading the safety components of pre-NDA and NDA/sNDA submissions, regulatory responses, label and label updates, RMPs.

**Responsibilities:**

- Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
- Responsible for safety surveillance for pharmaceutical / biological / drug –device combined products
- Lead and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans, NDA/sNDA submission – safety component
- Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
- Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams, executive leadership and externally, as needed
- Effectively write, review and provide input on technical documents independently
- Oversight and responsibility for leading the strategy for periodic reports (DSURs, PSURs, PADERs etc.)
- Responsible for implementing risk management strategies for assigned products
- Proactively engaging, inspiring, coaching and mentoring team and colleagues
- Opportunities to co-author publications and participate in initiatives to continue developing and growing as a safety leader
- Strong team player, able to adapt and work in a fast pace environment
- Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Qualifications

- MD / DO with 2+ years of internal medicine residency with patient management experience required; PhD or Clinical Pharmacology fellowship is preferred in addition to MD / DO, not required
- 2-5 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry.
- Previous experience supporting regulatory submissions (IND/BLA submissions) is required
- Oncology patient safety experience is required
- Effectively analyze and guide analysis of clinical data and epidemiological information
- Effectively present recommendations / opinions in group environment both internally and externally
- Write, review and provide input on technical documents
- Work collaboratively and lead cross-functional teams
- Ability to lead cross-functional teams in a collaborative environment

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

California

Associate Director, Process Technology

The Process Technology Lead is accountable for leading the Process Engineering Process Technology site team. This team is responsible for executing site Process Engineering projects, and for coordinating internal and external Process Engineering resource support for all site CAPEX and OPEX projects. The Process Technology team is responsible for all Process Engineering elements required to scope, develop, procure, construct, and qualify new equipment and facilities required to meet facility production throughput demands. This role manages a small to mid-sized team which may consist of both experienced professionals and managers. S(he) works closely with the Process Technology Leads at other sites. S/He coordinates routinely with Senior Director, Project Delivery and Director, Global Plasma Technology Ownership.

This position reports into Site Head of Process Engineering

**Project Responsibilities:**

• Leads multi-disciplinary project teams through life cycle activities to deliver capacity expansion capabilities to meet global and local strategic requirements.

• Develops Process Automation Strategy for project activities. Works closely with Execution Systems team to ensure that project instrumentation, automation, and alarm strategies align with industry standards and with product Quality by Design approach.

• Responsible for providing cGMP compliant processes and facilities suitable for FDA and global regulatory approval.

• Ensures that initiatives are aligned with the business objectives and strategic philosophy. • Oversees project teams responsible for completion of project lifecycle activities through turnover to routine commercial production.

• Oversees generation of regular project reports (financial updates, project schedules, risks and summary of current activities) for senior site management and Global Steering Committees. 2 Leadership Responsibilities:

**Leadership Responsibilities:**

• Directly oversees technical staff supporting a wide range of CAPEX and OPEX project responsibilities.

• Responsible for assessing the Process Technology project workload against the available resource pool and supplementing with contract resources. Manages and directs all contract resources in support of project activities.

• Responsible for mentoring and development of staff, including motivating in a manner that promotes the achievement of CSL’s business goals and objectives.

• Responsible for assessing the skillset of Process Technology team and bridging any gaps that are needed to support site project portfolio.

• Establishes performance goals and strategic/operational objectives for team. • Coaches, counsels, and appraises performance of personnel.

• Develops staff competencies & capabilities to enable business continuity, sustained success, and career development.

• Promotes high employee engagement and a positive work environment.

• Responsible for organizational design, resource requirements and staffing decisions.

• Recruits, retains, trains, and develops the team.

• Capable of influencing site and global leadership.

• Able to manage partnerships both internally and externally.

**Position Qualifications and Experience Requirements:**

Education:

• Undergraduate degree in Engineering/Science required.

• Advanced degree in Engineering/Science or MBA preferred.

Experience Required:

• 8+ years working in Process Engineering in Pharmaceutical, Chemical Manufacturing or similar industry.

• Demonstrated experience in process improvement development & execution.

• Strong communication and conflict management skills to influence project professionals and stakeholders, including non‐specialists, at all levels in the organization.

• Demonstrated experience in managing, organizing, developing and deploying best practice frameworks, processes, tools and templates in an Operations context, in alignment with Enterprise standards.

• 5 years or more experience working within a global matrix organization

• Involvement in cross-functional, multicultural and international teams.

Other Essential Knowledge

• Ability to work across a range of countries and cultures.

**Customer Orientation (Internal/External):**

• Creates strategies to stay ahead of industry-related changes. Drives alignment across the enterprise in order to serve customer needs. Spends time internally and externally with customers and stakeholders and genuinely seeks to understand their needs.

**Enterprise Results and Value Orientation:**

• Looks for outcomes that maximize the benefits for the enterprise, not just their department or function. Pursues value realization for the enterprise even if their function does not benefit.

**Collaboration and Influencing:**

• Champions a culture of inclusiveness and teamwork.

• Collaborates effectively with others and influences all stakeholders towards enterprise outcomes. Embraces conversations needed to deliver enterprise value.

**Strategic/Innovative:**

• Global perspective. Takes a broad view when approaching issues. Sees ahead to future possibilities & translates to breakthrough strategies. Collaborates to influence strategies of others and adapts own strategy towards enterprise value.

**Change Management:**

• Mobilizes others to initiate change; builds group momentum for change; embeds culture of change. Aligns change to enterprise strategies and direction.

**Interpersonal Savvy:**

• Relates well to all kinds of people, up, down, and sideways, inside and outside the organization; builds appropriate rapport; builds constructive and effective relationships; uses diplomacy and tact; can diffuse even high-tension situations comfortably.

*The expected base salary range for this position at hiring is $177,000- $209,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.*

**About CSL Behring**

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit [https://www.csl.com/](<https://www.csl.com/>) and CSL Plasma at [https://www.cslplasma.com/](<https://www.cslplasma.com/>).

**Our Benefits**

For more information on CSL benefits visit [How CSL Supports Your Well-being | CSL](<https://www.csl.com/careers/your-well-being>).

**You Belong at CSL**

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

**Equal Opportunity Employer**

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit [https://www.csl.com/accessibility-statement](<https://www.csl.com/accessibility-statement>).

Illinois

Insmed Incorporated

Medical Affairs Director, Medical Operations

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

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

**About the Role:**

This role is strategic, dynamic and responsible for providing coordination and contributions to the strategic optimization of Japan Medical Affairs across the four functions (Strategy, VPS (Value Evidence Outcome, Publication, Scientific Communication), Medical Education Field Medical). Additionally, the role will provide operational support for seamless, effective, and efficient collaboration among the four functions of Japan Medical Affairs (Strategy, VPS, MedEdu, FM).

**What You'll Do:**

- Contribute to the development and implementation of new or improved standards, tools, and templates that enhance the efficiency and impact of medical teams, and support/lead the achievement of timelines and milestones
- Regular budget management for medical activities that are On Time, On Scope, and On Budget
- Leverage knowledge of industry trends and best practices to propose new or improved operational methods through internal processes and outcomes
- Identify key business challenges, conduct root cause analysis, and develop/lead organizational and process improvement plans
- Collaborate with GME to achieve optimal balance between global harmonization and local adaptation (local rebalancing)
- Resource management (people, budget, systems) and process development necessary to support successful completion of global/local initiatives
- Collaborate with GKMA functional leaders and GME to support the development of consistent and integrated Medical Action Plans
- Develop and manage communication plans for GK and GMA (e.g., MA Monthly Meeting, Global Report, etc.)
- Develop and establish metrics that can measure the impact of activities, and manage and optimize them
- Collaborate with Medical Affairs and cross-functional stakeholders to identify issues and inefficiencies, and lead the creation and implementation of solutions to improve business outcomes
- Contribute to the following: (1) identification of optimization focus areas, (2) development of departmental goals, (3) ensuring alignment between medical initiatives and company-wide objectives, (4) defining metrics to evaluate the impact and progress of Medical Affairs activities and deliverables
- Leverage negotiation skills, cultural sensitivity/awareness, and technical knowledge to gain support and cooperation from other functions, contributing to the achievement of GKMA goals",
- Collaborate with GKMA Head and other appropriate stakeholders to develop, optimize, and implement medical governance and procedures
- Keep the team informed of evolving industry regulations and guidelines to ensure compliance
- Play a critical role in Medical Affairs transformation while building high-performing teams
- Medical Affairs communications that provide visible and valuable contributions to internal and external stakeholders in Medical Affairs transformation

**Who You Are:**

- Bachelor's degree or higher (MBA preferred)
- 15+ years of industry/relevant professional experience
- 10+ years of hands-on experience in Medical Affairs
- Proven track record of success in fast-paced and dynamic environments, self-management capabilities, and ability to work with minimal supervision • Ability to anticipate areas of growth, improvement, enhancement, and potential risks
- Accurate and effective communication skills in both verbal and written formats
- Ability to manage external vendors and provide clear, concise instructions • Effective leadership through influence, motivation, and ability to ensure compliance adherence across departments
- Embody Insmed's Values and GKMA's MVV (Mission, Vision, Values) Demonstrated ability to interact effectively in a dynamic workplace environment with diverse talent

Required Skills:

- Program Management
- Influential Leadership
- Strategic Thinking and Logical Thinking
- Change Management
- High Communication Skills (Japanese and English)
- High Listening Skills • High Problem-Solving Skills
- Deep Knowledge of Medical Affairs Responsibilities
- Knowledge of Pharmaceutical Industry Regulatory Environment
- High Ethical Standards
- Results-Oriented

Domestic and/or international travel required (minimum of 10 %)

**Life at Insmed**

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

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

社員一人一人の充実した働き方を実現するためのサポート：

• ワークライフバランスの実現

フレキシブルな勤務時間や充実した休暇制度

• 魅力的な報酬制度

退職金制度、株式報酬制度、従業員持株制度（ESPP）への参加機会

• キャリア開発支援

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

• 先進的な学習支援

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

• グローバルの表彰制度や従業員リソースグループ活動

• ハイブリッドワーク環境の整備

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

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

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

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

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

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

Other Non-US

Manager, Contract Manufacturing

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

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

**About the Role:**

We’re looking for a Manager, Contract Manufacturing on the Manufacturing team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, Manufacturing Sciences & Technology, you’ll be responsible for the development, optimization, scale-up, and routine execution of manufacturing operations for pharmaceutical products. A focus for this role is on-site presence at contract manufacturing organizations (CMOs) during production.

**What You'll Do:**

In this role, you’ll have the opportunity to collaborate with cross-functional teams, including R&D, manufacturing, quality assurance, regulatory CMC,and CMOsto ensure robust and compliant production processes.You’ll also be responsible for:

- **CMOOversight**:Real-timeand on-sitesupervisionof CMOs execution ofroutine manufacturingas well astechnology transfer, optimization,new equipmentinstall,andprocessvalidationactivities
- **Process Development & Optimization**: Design, develop, andoptimizemanufacturingprocesses for pharmaceutical APIs and formulations;with an emphasisonparticle engineeringviaspray drying andlow fill weightpowder encapsulation.
- **Scale-Up & Tech Transfer**:Contribute tothe transition of spray dryingand other drug productprocesses from pilot and commercial scaleatprimary and secondary CMOs.
- **Troubleshooting& Operations**:Troubleshoot spray dryingand other drug product processequipment, ensuring efficiency and compliance with GMP regulations.
- **Process Validation**: Develop and execute validation protocols (IQ, OQ, PQ) for spray dryingand other drug productprocesses. Prepare finalized spray dryand encapsulation processesfor product registration, validation, and commercial readiness.
- **Cross-Functional Collaboration**: Work closely with formulation scientists, manufacturing teams, and regulatory affairs to ensure smooth product development and commercialization.
- **Regulatory Compliance**: Ensure all processescomply withFDA, EMA, and ICH guidelines for pharmaceutical manufacturing.
- **Data Analysis & Reporting**: Analyze process data,identifycritical process parameters, and prepare technical reports for internal and regulatory submissions.

**Who You Are:**

You have a Bachelor’s degree along with 5 years of experience in pharmaceutical process engineering or manufacturing. You are or you also have:

- Experience withlate phase clinical andcommercial CMO operations.
- Strong background in spray drying technology for pharmaceutical applications.
- Working knowledge of quality systems, validation principles, engineering design, and statistical process control fundamentals.
- Proven ability toidentify, assess, and solve problems using root cause analysismethodologyand document investigation and outcomes in a compliant manner.
- Familiarity with DOE (Design of Experiments) and statistical process control.
- Experience with GMP manufacturing,technology transfer,process scale-up, and validation.
- Ability to work independently,remotefrom central leadership.
- Strong interpersonal skills and the ability to work in afast paced, multidisciplinary environment.
- Strong verbal and written communication skills are essential.

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

- Background in capsule filling and blister primary packaging 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 Requirements**

This position involves frequent global travel (up to 50%) for visits to our CDMO sites in the US and EU.

\#LI-BA

\#LI-REMOTE

**Pay Range:**

$124,000.00-161,000.00 Annual

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

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

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

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

Nationwide

Director, Global Logistics

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

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

**About the Role:**

The Director of Supply Chain & Logistics is responsible for leading Insmed's global logistics operations supporting Commercial, Clinical and Research & We’re looking for a Director of Supply Chain & Logistics to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, Supply Chain & Logistics, you’ll lead Insmed's global logistics operations supporting Commercial, Clinical and Research & Development organizations. This role provides strategic and operational leadership for domestic and international transportation, import/export compliance, warehousing and distribution activities across a global outsourced manufacturing network.

You’ll be the business owner for logistics operations and external logistics partners, ensuring compliant, reliable and cost-effective movement and storage of materials and products. The role leads logistics-related projects including new product launches, new distribution models, external warehouse implementations, transportation network changes, CDMO onboarding, and continuous improvement initiatives.

**What You'll Do:**

In this role, you’ll have the opportunity tomanage a team of Logistics Managers, develop logistics strategy, drive vendor performance through KPIs and governance, manage departmental budgets, and partner cross-functionally with Technical Operations, Clinical Supply Chain, R&D, Quality, Regulatory Affairs, Finance and Commercial organizations to ensure uninterrupted supply.You’llalso:

- Develop and execute the globallogisticsstrategy supporting Commercial, Clinical, and R&D operations, ensuring scalable capabilities to support company growth.

- Assess geopolitical, trade, transportation, and regulatory risks, developing mitigation strategies to strengthen supply chain resilience and business continuity.

- Drivelogisticsprocess standardization and continuous improvement initiatives to improve service, compliance, and operational efficiency.

- Oversee domestic and international transportation, warehousing, and distribution operations, ensuring compliant, reliable, and cost-effective movement of commercial products, clinical materials, APIs, drug product, and development materials.

- Lead transportation disruption management, business continuity planning, andlogisticsperformance through KPIs including service, cost, transit time, customs clearance, and cold chain performance.

- Optimize transportation networks, inventory positioning, distribution strategies, and warehouse operations to support businessobjectives.

- Own global import/export, customs, and trade compliance activities, ensuring compliance with all applicable regulations and Good Distribution Practices.

- Monitor changes in global trade regulations, tariffs, sanctions, and customs requirements, assessing business impact and leading implementation of required operational changes.

- Partner with Customs Brokers, Freight Forwarders, Legal, Regulatory Affairs, Finance, and other stakeholders to ensure compliant and efficient global product movement.

- Leadlogisticsworkstreams supporting product launches, manufacturing transfers, new CDMO onboarding, warehouse implementations, transportation network changes, and other strategic supply chain initiatives.

- Manage strategic relationships with third-partylogisticsproviders, freight forwarders, customs brokers, warehouse providers, and specialtylogisticspartners through governance, performance metrics, and continuous improvement.

- Evaluate business cases and recommendlogisticsinvestments that improve operational performance, resilience, and total landed cost.

- Serve as thelogisticsand global trade subject matter expert, partnering across Commercial, Clinical, R&D, Manufacturing, Quality, Regulatory Affairs, Finance, and senior leadership to support strategic businessobjectivesand ensure uninterrupted global supply.

**Who You Are:**

You have aBachelor’sdegreealong with10years of experience insupply chain,logisticsor operations within biotechnology, pharmaceutical or life sciences industries.

Youare or you alsohave:

- Experience supporting commercial product distribution

- Demonstrated leadership experience managing and developing high-performing teams

- Deep knowledge of global transportation,warehousingand import/export operations

- Strong understanding of pharmaceutical Good Distribution Practices (GDP)

- Experience managing temperature-controlled and high-value pharmaceutical shipments

- Strong vendor management and supplier governance experience

- Experience leadinglogisticsoperations across multiple regions and external manufacturing partners

- Strong financial acumen including budgeting,forecastingand cost optimization

- Excellent negotiation and influencing skills

- Strong executive communication and presentation skills

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

- MBA orMaster'sdegree

- Degree in Supply Chain, Logistics, Engineering,Businessor related discipline

- Experience supporting clinical supply chains and/or R&D operations

- Experience working within a virtual manufacturing environment utilizing CDMOs and third-partylogisticsproviders

- Global product launchesrare disease or specialty pharmaceuticals

- Cold chainlogistics

- Clinical triallogistics

- Customs valuation and trade compliance

- Dangerous goods transportation

**WhereYou’llWork**

This role is based out of our Bridgewater, NJ office and requires an in-person presence 2-3 days a week to support hands-on collaboration, access specialized equipment, and/or operational needs.

**Travel Requirements**

This role requires occasional travel (approximately10%–20%)

\#LI-HYBRID

\#LI-MC1

**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

Director, Medical Safety Lead - DSPV, Gene Therapy

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, Medical Safety Lead - DSPV Gene Therapy to help us expand what’s possible for patients with serious diseases. Reporting to the Sr Director, DSPV Gene Therapy Safety Lead, the Director, Medical Safety Lead serves as the DSPV subject matter expert for assigned products, maintaining deep and up-to-date knowledge of the product portfolio and associated safety profiles.

This role is responsible for safety surveillance, risk management, and risk communication across assigned development and marketed products. It includes medical evaluation of individual adverse event reports, oversight of aggregate report generation and safety documentation, and collaboration on labeling updates. The position also provides expert DSPV support to both internal and external stakeholders.

**What You'll Do:**

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

- Conduct safety signal detection activities, monitoring, evaluation, interpretation, and appropriate management and communication of safety information.
- Lead the Safety Review Team(s) for assigned products and development compounds and manage the ongoing and cross functional assessment of benefit risk profiles and related actions, including writing and updating of the benefit-risk documents.
- Provide medical expert safety review input into all critical documents for clinical development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs).
- Work with the DSPV leadership to develop the strategy and implementation of safety and benefit-risk management for assigned products; develop key content of Risk Management documents (RMPs, REMS) for assigned products.
- Provide input into the writing of periodic reports for assigned products; provide medical interpretation, review, and approval for required reports.
- Share DSPV and medical expertise with global counterparts in other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal.
- Provide expert safety input to the clinical development program for assigned products and development compounds.
- Ensure, in collaboration with Regulatory Affairs labeling team an accurate representation and communication of the safety profile of assigned products and development compounds.
- Provide integrated safety input into all regulatory documents, thorough assessment of safety profiles for Due Diligence projects, and provide Drug Safety input for product recall issues or Health Hazard Evaluations and Dear Healthcare Professional letters.
- Respond to inquiries from regulatory authorities on safety issues.

**Who You Are:**

You must have an MD or DO with 5+ years of experience in Drug Safety/Pharmacovigilance within a pharmaceutical industry setting across both investigational and marketed products. Additionally, you have:

- Experience reviewing and preparing scientific or regulatory documents from large volumes of scientific information.
- Knowledge and understanding of national & international Pharmacovigilance and regulatory guidelines.
- Experience presenting drug safety topics for regulatory authorities or at conventions, meetings, etc.
- Impeccable communication skills, both verbal and written.
- Excellent organizational skills with a strong attention to detail, clarity, accuracy, and conciseness.
- Demonstrated ability to interact successfully in a dynamic and culturally diverse workplace.

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

- Master of Public Health (MPH) is a plus.
- 2+ years’ experience in Clinical Patient Care is strongly preferred.
- Drug safety database knowledge is preferred.
- Experience working on gene therapy products is a plus.
- Product defense before a national or international regulatory authority 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. Occasionaltravelfor team meetings or events may be expected.

**Travel Requirements**

This role requires occasional domestic travel (up to 20%).

\#LI-MM1

\#LI-Remote

**Pay Range:**

$247,000.00-337,000.00 Annual

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

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

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

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

Director, Pharmacovigilance / Product Safety

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

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

**About the Role:**

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

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

**What You'll Do:**

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

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

**Who You Are:**

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

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

**Where You’ll Work**

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

**Travel Requirements:**

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

\#LI-TB1

\#LI-Remote

**Pay Range:**

$247,000.00-337,000.00 Annual

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

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

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

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

Director, Drug Safety & Pharmacovigilance - Japan

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

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

**About the Role:**

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

**What You'll Do:**

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

**Who You Are:**

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

**WhereYou’llWork**

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

**Travel Requirements**

This role requires occasionaldomestic/internationaltravel (approximately20%)

**Life at Insmed**

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

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

社員一人一人の充実した働き方を実現するためのサポート：

• ワークライフバランスの実現

フレキシブルな勤務時間や充実した休暇制度

• 魅力的な報酬制度

退職金制度、株式報酬制度、従業員持株制度（ESPP）への参加機会

• キャリア開発支援

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

• 先進的な学習支援

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

• グローバルの表彰制度や従業員リソースグループ活動

• ハイブリッドワーク環境の整備

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

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

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

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

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

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

Manager, Project Management – Technical Operations

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

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

**About the Role:**

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

**What You'll Do:**

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

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

**Who You Are:**

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

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

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

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

**Where You’ll Work**

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

**Travel Requirements**

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

\#LI-BA

\#LI-REMOTE

**Pay Range:**

$124,000.00-161,000.00 Annual

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

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

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

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

Senior Manager, Global Medical Strategy & Communications Operations

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

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

**About the Role:**

We’re looking for a Senior Manager, Global Medical Strategy and Communications (GMSC) Operations on the Medical Affairs Strategy team to help us expand what’s possible for patients with serious diseases. Reporting to the Global Medical Lead, you’ll be responsible for maintaining systems and processes critical to the compliant and efficient execution of the global GMSC plans. GMSC is responsible for the development and delivery of internal and external medical strategies and related tactics. Critical operations functions within the team include facilitation of contracting and budget planning, and the development of project management tools, reports, and timelines for complex projects across the team. Activities include optimal departmental efficiency, consistency, and appropriate resource utilization.

**What You'll Do:**

In this role, you’ll have the opportunity to support the Global Medical Lead to ensure that the department develops and delivers tactics efficiently and consistently, while adhering to corporate policies and external regulations. You’ll also:

- Work with the medical directors and sci comms directors to develop and track budgets; facilitate contracting; participate in annual budget and forecasts
- Establish/maintain and lead training on data management systems that effectively support GMSC projects
- Work closely with the team to facilitate other administrative activities such as management and maintenance of folders, setting and maintaining meeting minutes and ensuring follow up actions completed
- Build reports based on identified departmental and corporate goals
- Proactively identify potential timeline risks, issues, and deviations from plans and budgets, and collaborate to implement solutions
- Assist in building and maintaining key meeting slides incorporating identified timelines and goals
- Build and maintain productive relationships with internal partners (Finance, Legal, Compliance, HEOR) and external vendors/agencies

**Who You Are:**

You have a Bachelor’s degree along with 5 years of experience in the pharmaceutical/biotech industry, primarily in Medical Affairs project management. You are or you also have:

- Strong organizational skills and the ability to manage multiple concurrent projects with competing priorities in a fast-paced environment
- Apply structured project management approaches (timelines, trackers, dashboards) to drive on-time, on-budget delivery
- Proficiency with Microsoft Office applications and document management systems (e.g. SharePoint, Veeva Vault, Smartsheets, etc.)
- Experience in determination of business requirements and launch of document management systems preferred
- Ability to manage external vendors and provide clear, concise direction
- Must have excellent communication skills (verbal and written)
- Strong attention to detail, clarity, accuracy and conciseness
- Demonstrated ability to work effectively within collaborative and cross-functional teams
- Must successfully exhibit Insmed’s five (5) core corporate values of: Collaborative Accountability, Passion, Respect and Integrity; along with any other position specific competencies
- Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace

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

- Advanced degree preferred

**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 role requires occasional domestic travel (approximately 10%)

\#LI-JK

\#LI-Remote

**Pay Range:**

$133,000.00-173,000.00 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.*

Senior Manager, Technical Operations Strategy

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 Senior Manager, Technical Operations Strategy on the newly formed Technical Operations Strategy team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, Technical Operations Strategy, you’ll build from the ground up, work across manufacturing, supply chain, and Product Development (CMC Small Molecule, Large Molecule and Gene Therapy) to identify where strategic clarity is needed and go deliver it.

**What You'll Do:**

In this role, you’ll have the opportunity to work directly with Technical Operations leadership and functional leaders to define and advance the organization's most pressing strategic priorities.

You’ll also:

- Dig into complex, cross-functional questions, structure them clearly, and bring back a point of view. Identify where the thinking needs to happen and go do it
- Support manufacturing network decisions by developing scenarios, evaluating trade-offs, and helping leadership understand the long-term implications of site, supplier, and internal versus external manufacturing choices as programs move from clinical to commercial
- Build and maintain a clear picture of supply risk across the portfolio, identifying vulnerabilities and developing mitigation strategies and continuity plans that protect patient access
- Contribute to Product Development (CMC Small Molecule, Large Molecule and Gene Therapy) strategy by ensuring that early product development decisions and their downstream implications for manufacturing, supply, and commercial readiness are visible and accounted for in planning
- Support commercial readiness and launch planning by embedding supply continuity requirements early across the portfolio
- Build and leverage digital tools and data platforms to develop analytical models, dynamic dashboards, and live data integrations that make supply risk, network planning, and portfolio insights accessible and decision-ready
- Develop clear, concise materials that help leadership prioritize, escalate, and act across governance and portfolio-level discussions
- Build relationships at every level, within Technical Operations, across functions including Quality Assurance, Regulatory Affairs, Supply Chain, and Commercial, and with external partners
- Take on work that does not fit neatly into anyone else's lane and contribute to defining where this group can add the most value
- Perform other duties and special assignments as needed

**Who You Are:**

You have a Bachelor’s degree along with 5 years of experience in roles that required structured thinking, independent problem solving, and clear communication of complex ideas or a Master’s degree and 3 years of experience.

You are or you also have:

- Experience in strategy, business operations, project management, supply chain, or analytical functions within pharmaceutical, biotech, or life sciences
- Demonstrated ability to take an ambiguous problem, structure it, and deliver a clear recommendation without being told exactly how to get there
- Strong analytical skills and comfort working with data to build scenarios, assess risk, and support decision-making
- Excellent written and verbal communication skills. You do not need to be a polished presenter, but you do need to be able to communicate clearly and directly with senior leaders
- Proven ability to work independently and manage multiple priorities in a fast-moving environment
- Comfortable operating without a large team or established infrastructure behind you

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

- 7+ years of experience
- Experience in a strategy consulting, internal strategy, or business operations role, whether at a consulting firm or inside a pharma or biotech company
- Familiarity with supply chain risk, business continuity, or manufacturing network strategy
- Exposure to late-stage clinical or commercial launch planning in a regulated environment
- Experience supporting a portfolio of programs with shared dependencies, including complex modalities such as gene therapy
- Background in process improvement, operational excellence, or Six Sigma methodologies (Green Belt or Black Belt)
- PMP or equivalent project management experience

**Where You’ll Work**

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

**Travel Requirements**

This role requires occasional domestic/international travel (approximately 15-20%).

\#LI-HYBRID

\#LI-MC1

**Pay Range:**

$124,000.00-161,000.00 Annual

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

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

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

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

Vice President and Global Head of Drug Safety and Pharmacovigilance

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

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

**About the Role:**

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

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

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

**What You'll Do:**

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

**Strategic Leadership**

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

**Safety Science & Medical Oversight**

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

**Global Regulatory Compliance**

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

**Operational Excellence & Digital Innovation**

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

**Cross-Functional & External Engagement**

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

**Who You Are:**

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

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

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

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

**Where You’ll Work**

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

**Travel Requirements**

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

\#LI-MM1

\#LI-Remote

**Pay Range:**

$365,000.00-497,000.00 Annual

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

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

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

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

Specialist, Quality CMC Operations

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

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

**About the Role:**

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

**What You'll Do:**

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

You’ll also:

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

**Who You Are:**

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

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

**WhereYou’llWork**

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

**Travel Requirements**

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

\#LI-hybrid

\#LI-EG1

**Pay Range:**

$39.00-50.00 Hourly

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

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

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

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

Summer Intern – Clinical Supply Chain and Logistics

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

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

**About the Role:**

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

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

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

**What You'll Do:**

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

You'll also:

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

**Who You Are:**

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

You are or you have:

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

**Where You’ll Work**

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

**Pay Range:**

$20.00-35.00 Hourly

**Life at Insmed**

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

Our internship offerings include:

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

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

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

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

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

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

Sanofi US

Manager Franchise Operations Global Rare Diseases

**Job title:** Manager Franchise Operations Global Rare Diseases

**Location:** Cambridge, MA

**About the Job**

The Global Rare Diseases Franchise is a key strategic business unit within Sanofi, focused on developing and delivering life-changing therapies for patients with rare diseases worldwide. The Franchise Strategy and Operations team plays a critical role in enabling the success of this mission through operational excellence, strategic coordination, and effective cross-functional collaboration.

As a Manager within this team, you will be at the heart of supporting the team's operational effectiveness, helping to drive initiatives that impact patients with rare conditions globally. This role offers a unique opportunity to contribute to meaningful work in a dynamic environment, collaborating with talented professionals dedicated to transforming the lives of patients with rare diseases. You will gain broad exposure to various aspects of the rare disease business while developing expertise in operational management within a global pharmaceutical organization.

The ideal candidate will thrive in a fast-paced environment, demonstrate exceptional organizational abilities, and possess strong communication skills to effectively coordinate across multiple stakeholders and functions. This position offers growth potential and the chance to make a significant impact on the operational excellence of the Global Rare Diseases Franchise.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve peoples lives. Were also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological conditions. In Specialty Care, youll help deliver breakthrough treatments that bring hope to patients with some of the highest unmet needs

**About Sanofi**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

**Main Responsibilities**

Project Management

- Support the Franchise Operations team with various ad hoc, time-bound priority projects for the franchise

Meeting Coordination

- Coordinate and support town halls and employee engagement activities.
- Participant in and capture key insights and follow up from critical franchise operations-driven meetings.

Franchise Operations and Internal Communications

- Manage the Franchise calendar
- Maintain and update team distribution lists to ensure proper communication flow
- Manage the global rare diseases mailbox, ensuring timely responses and appropriate routing of inquiries
- Support the team with Product Review Board submissions
- Partner with Corporate Communications to maintain communication channels across the franchise
- Oversee coordination with Graphic Design hub at the Franchise level
- Manage a variety of Franchise-wide routine processes associated with data collection & sharing.

Onboarding & Team Development

- Deploy and maintain onboarding resources to ensure effective delivery to new team members based on project standards.
- Develop and facilitate several employee engagement opportunities for the Global Rare Franchise.

Communications & Stakeholder Management

- Support internal communications strategy and execution
- Facilitate cross-functional collaboration on various projects and initiatives
- Manage the Franchise SharePoint & Teams site

**About You**

**Basic Qualifications**

- Bachelor's degree
- 3-5 years of experience in operations, project coordination, or administrative management
- Strong organizational and time management skills
- Proven ability to communicate effectively in teams, small groups and in a large group presentation environment
- Proficiency with Microsoft Office suite (Outlook, Excel, PowerPoint, Teams)
- Ability to work independently under minimal supervision and direction
- Travel approximately 10%

**Preferred Qualifications**

- Experience in pharmaceutical or healthcare industry
- Experience supporting senior leadership teams
- Project management certification or experience

**Competencies**

- Strong attention to detail and accuracy
- Excellent interpersonal skills and ability to work with diverse stakeholders
- Proactive problem-solving approach
- Ability to maintain confidentiality with sensitive information
- Adaptability and flexibility in a changing environment
- Collaborative team player with ability to work independently

**Why Choose Us?**

- Bring the miracles of science to life alongside a supportive, future-focused team
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SG

\#LI-GZ

\#LI-Onsite

\#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

Massachusetts

Eli Lilly and Company

Engineer - Project Manager - GFD

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.

The Global Facilities Delivery (GFD) Organization delivers new and renovated capital assets around the world. Our mission is accomplished through a highly leveraged organization of design, construction, and qualification contractors. Many of the assets delivered focus on medical innovation and delivering innovative solutions to patients. Some of the assets delivered will expand the supply of existing medicines or strengthen the supply chain.

**Key Objectives/Deliverables:**

- Project Management: Lead teams to deliver large programs of at least $50M USD or more in capital assets and/or support a workstream or node of a larger program of $200M or more in capital assets. These teams will consist of both Lilly and Non-Lilly professionals to safely achieve project objectives from front-end planning (conceptual design) in a Brownfield or Greenfield site through operational qualification (cradle to grave). Project objectives are defined as delivering asset capability or capacity with safety, cost, schedule, and quality assurance.
- Interface/Communication: Ability to work from a regional distance from corporate headquarters while developing and maintaining effective communication with GFD program leadership, the project team, governance teams, business partners, and other stakeholders. Facilitate issue resolution, anticipate scope changes, and implement safely with quality, speed, and value.
- Compliance: Lead/influence with a disciplined, structured approach to project management based on compliance with Company Policies and Procedures.\\
- Safety/Environment: Develop and maintain safety and environmental execution plans for projects. Ensure compliance with safety and environmental policies, procedures, and work rules for project personnel, contractors, and subcontractors from conceptual design through operational verification.

**Minimum Requirements:**

- Bachelor of Science – Engineering field or related to project management
- Minimum of 5+ years of previous experience in capital project delivery in industrial or manufacturing facilities.
- Willingness to relocate and/or travel to locations outside of home state/country.
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Additional Preferences:**

- Project Size: Previous experience on projects or multiple projects of \>$10M.
- Previous experience managing greenfield projects.
- Pharma manufacturing experience.
- Capital Project Management Experience in Pharma manufacturing facilities, such as: Bulk API, sterile products, secondary packaging, Devices and to a lesser extent lab projects.
- Experience in the following areas: GMP manufacturing, LEAN, Automation, construction, construction quality, project controls, the engineering disciplines, safety, scheduling
- The capacity to achieve results and influence through people is critical.
- Demonstrated ability to work from long distances with little supervision.
- Must exhibit a good sense of judgment in decision making, without the need for management approval while at the same time keeping management informed and engaged on critical issues.
- Effective communication skills both written and verbal.
- Ability to influence personnel and organizations without having direct administrative responsibility for them
- Competency in a foreign language(s).
- Professional Engineer (PE) or equivalent technical certification.
- Project Management Professional (PMP) certification.
- Experience in working and/or living outside the U.S.
- Demonstrated willingness to embrace the concept of continuous improvement and be an agent for change.

**Additional Information:**

- Travel is required and will vary by project.
- Full relocation to one of the posting locations listed on this requisition is required for the duration of the project. Throughout the hiring process, you may share preferences and further detail about your mobility with the hiring team.
- This is an onsite role; onsite presence is required (this is NOT a remote role).
- Multiple job levels can be hired on this posting, and business title will vary based on job title (i.e. Engineer/Sr. Engineer/Principal Engineer/Sr Principal Engineer – Project Manager – GFD).

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

$66,000 - $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

Indiana

Immuneering

Associate Director, Formulations Development (Remote)

**ABOUT IMMUNEERING**

Immuneering Corporation (Nasdaq: IMRX) is a clinical-stage biopharmaceutical company developing oncology therapies using its proprietary Deep Cyclic Inhibition platform. Our lead asset, atebimetinib (IMM-1-104), is an oral, once-daily Deep Cyclic Inhibitor of MEK in active Phase 2 and Phase 3 (MAPKeeper 301) clinical trials in pancreatic cancer and RAS-mutant non-small cell lung cancer, as well as additional solid tumor programs. We are committed to delivering transformative treatments to patients with limited options through rigorous science and a collaborative, mission-driven culture.

The Associate Director, Formulation Development will be responsible for overseeing all aspects of Immuneering’s drug product development program, from candidate nomination through the clinical development stage of product lifecycle. This entails the conduct of pre-formulation studies, formulation development, tech transfer, scale-up and manufacturing. This position requires experience in solid oral dosage formulation development, including enabling formulations for poorly soluble (BCS Class II/IV) compounds, and API form characterization and selection. This position also requires a thorough understanding of the principles of quality by design (QbD), and extensive experience in scientific technical writing for drug development and regulatory submissions. Prior experience managing drug product process development and manufacture at CROs and CDMOs is also critical for this position. The successful candidate will be a highly motivated, proactive team player with a strong background in formulation science and process development, and a proven track record of accomplishments. This position will report to the Head of CMC.

**Job Functions and Responsibilities**

• Conduct pre-formulation studies, including API form characterization and selection, in collaboration with Process Chemistry

• Design, execute, and interpret formulation screening and excipient selection studies

• Define phase-appropriate formulation approaches that balance clinical needs, manufacturability, regulatory expectations, and commercial considerations

• Develop innovative, robust, efficient, scalable and cost-effective drug product manufacturing processes

• Act as the main point of contact directing drug product manufacturing process development, technology transfer and manufacturing campaigns at external CDMOs, including development, review and approval of process development protocols, master batch records and manufacturing campaign reports

• Provide person-in-plant support for drug product manufacturing campaigns as required

• Review and approve executed batch records, and provide technical review and approval for quality investigations and batch disposition records

• Assist in establishing critical quality attributes and critical process parameters for drug products in development

• Author or review development reports and risk assessments

• Author assigned CMC sections to support regulatory filings (such as IND, IMPD, NDA, MAA) and respond to questions from regulatory agencies

• Serve as drug product SME for cross-functional project teams

• Collaborate within CMC and across the wider development team to deliver quality drug product for clinical trials within required timelines • Serve as a technical expert and keep current in the field of formulation and process development

• Work in compliance with cGMP, safety and regulatory requirements

• Champion a strong winning culture through the relentless pursuit of excellence, fostering a collaborative and collegial approach to teamwork, and a first-in-class quality organization

**Education, Skills and Qualifications**

**Required:**

• PhD in pharmaceutics, pharmaceutical sciences, chemical engineering, chemistry or related discipline with 8+ years of industry experience; or MS or BS degree in pharmaceutics, pharmaceutical sciences, chemical engineering, chemistry or related discipline with 12+ years of industry experience

• A foundational understanding of pre-formulation studies, formulation design and development and drug product manufacturing process development

• Experience in formulation development of poorly soluble (BCS Class II/IV) compounds (e.g., amorphous solid dispersions (spray-dried dispersions, hot-melt extrusions), lipid-based and self-emulsifying formulations (SEDDS, SMEDDS, lipid suspensions, LNPs, SLNs), micro-encapsulation, micro/nano formulations (nanocrystals, nanosuspensions), salt formulations, co-crystals, etc.)

• Experience in drug product technology transfer and manufacture

• Experience managing CDMOs for research, development and manufacturing campaigns

• Solid understanding of relevant FDA, EMA, and ICH regulatory guidelines as applicable to drug product manufacturing, and current standards of practice in the industry

• Demonstrated ability to apply regulatory guidance to formulate practical solutions and development strategies

• A critical and strategic thinker with exceptional decision-making skills and the ability to work independently in a fast-paced, high-pressure setting

• Excellent technical writing skills; experience with authoring regulatory submissions and responding to regulatory questions

• Values-based leadership and commitment to integrity and ethics in pharmaceutical product development and manufacture

**Preferred**

• Strong theoretical and practical background in relevant pharmaceutical technologies such as dry/wet granulation, extrusion, spray drying, tableting and coating

• Fundamental understanding of physicochemical and biopharmaceutical properties as related to formulation design

• Application of QbD principles to the drug development process, including experience in developing quality target product profiles (QTPPs), defining critical quality attributes (CQAs) and critical material attributes (CMAs), and determining critical process parameters (CPPs) using failure mode and effects analysis (FMEA) and other risk assessment tools • Expertise in pediatric formulation development

• Thorough understanding of analytical techniques used for API form characterization and selection and pre-formulation studies including HPLC, LC-MS, XRPD, DSC, Dissolution, and KF

• Experience in IND/IMPD and NDA/MAA submissions

• Experience in managing quality investigations

• Self-motivated, detail-oriented, with a continuous quality improvement mindset, high personal integrity, and excellent time management and organizational skills

• Excellent communication, problem-solving and organizational skills; thrives in a cross-functional team environment

**Additional Information**

• Travel: 10 to 20%

• Location: Remote

**EQUAL OPPORTUNITY EMPLOYER**

Immuneering Corporation is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.

*The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned. The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.*