Clinical

AbbVie

Senior Manager, Clinical Quality Assurance - Americas

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

**This hybrid role could be based at any of AbbVie's location in the US such as North Chicago, IL Cambridge, MA, Worcester, MA Irvine, CA, San Francisco, CA or Florham, NJ**

**Purpose:**  As an independent RDQA Organization, our commitment is to drive quality excellence as a strategic advantage across all stages of discovery and development for the lifecycle of the product to achieve

product realization and to accelerate access to innovative therapies for our patients. AbbVie’s R&D

global trial footprint has been expanding due to growth in the pipeline and the complexity of global

development resulting in an overall increase in global trials in the Affiliates. In addition, the

acquisition of Allergan and integration with AbbVie have significantly increased clinical trials managed

from the Affiliates. RDQA AREA focuses on proactive quality and quality output in support of clinical

development/R&D enterprise within designated countries around the world.

AREA supports countries in Europe, Americas and Intercontinental as defined by AbbVie. The

expected results in the Affiliates are as follows; quality excellence, realization of R&D goals and

objectives for submission of new therapies including but not limited to adherence to One AbbVie

Quality System, execution of RDQA Quality System Excellence (CAPA, Change Management, Quality

Risk Management, Documentation Standards) and the assurance of integrity data. Scope includes

R&D and clinical research activities conducted by Affiliates or AbbVie within the region, to achieve

first pass approvals thereby advancing the pipeline.

This position will report to RDQA Associate Director or RDQA Global Director, AREA

**Major Responsibilities:**

- The RDQA AREA Senior Manager will provide support for the assigned countries and region and will
- be responsible for the implementation/execution of activities related to proactive quality
- management. The following are key responsibilities:
- Maintain a close, collaborative relationship with RDQA functions impacting clinical research
- within designated Affiliates in the assigned countries and region.
- Establish collaborative-working relationship with clinical development leaders and staff within
- designated Affiliates to advance the AbbVie Quality System, drive quality excellence, and
- achieve first pass approval for market authorization by health authorities.
- Oversee quality and compliance in a regulated environment including AbbVie policies and
- procedures and country and regional standards and regulations.
- Lead and/or collaborate on development of risk identification and risk mitigation or control
- strategies for clinical research activities including clinical trials within designated countries with
- periodic reviews of quality and compliance data for the purposes of continuous improvement.
- Establish quality measures with the desire to achieve RDQA quality goals. Drive quality strategy
- in designated countries and region in conjunction with other RDQA AREA personnel.
- Manage governance/oversight that is “fit for purpose” and in relation to the One AbbVie
- Quality System. Identify trends, root causes, and potential risks to mitigate and/or prevent
- issues that impact clinical research. Drive vision of continuous state of regulatory
- preparedness.
- Ensure consistent understanding of the quality requirements for clinical research activities
- within Affiliates, works closely with Affiliates R&D Management on health of Quality System,
- identifies issues of quality and compliance that will impact overall goals and desired outcomes.
- Maintain awareness of all applicable regulations and develop appropriate standards to measure
- quality in assigned countries and region relating to clinical research.
- Support necessary supplier visits, audits and vendor qualifications
- Develop inspection strategy in collaboration with AREA Associate Director and relevant
- functions and provide inspection-readiness support for all local / regional Health Authority
- inspections.
- Provide oversight, support and follow-up (inspection report response) for local Health Authority
- inspections with employees and management in assigned countries and region. Participate in
- Health Authority inspections as needed.
- Determine need for country/process assessments/audits in collaboration with Clinical Audit and
- Clinical PM.
- Conduct audits as required to assess compliance with regulations, guidelines, policies and
- procedures and Sponsor requirements. Effectively communicate audit results, both orally and
- in writing. Review and approve corrective action plans/audit responses.
- Support the development of robust audit and inspection responses through coaching and
- education.
- Mentor AREA Managers/AREA Associates or line management as additional Lead responsibility

Qualifications

- Bachelor's degree required preferably in Biology, Nursing, Pharmacy, or other medical science
- degree combined with equivalent technical experience. 8+ years of biopharmaceutical /
- medical device industry experience in quality assurance, compliance, regulatory affairs,
- clinical research and/or other related development functions that includes 3 years in in
- Strong understanding of local and global regulatory and legal requirements and of the
- approach and perspectives of regulatory agencies. Ability to ensure strategic risk focus with
- evolving global regulations and expectations. Agile and able to respond rapidly to unplanned
- events and changing regulatory requirements and expectations.
- Thorough knowledge of quality systems, auditing standards and quality management.
- Motivates and can influence others, including those over whom they have no direct authority.
- Strong analytical skills with an ability to organize work in a logical, thorough & succinct
- manner.
- Ability to work at an experienced level, demonstrating effective leadership in interactions
- with business partners at all levels.
- Excellent written & oral communication skills including presentation and influencing skills.
- Strong negotiation, influencing and collaborating abilities with excellent networking skills.
- Ability to foster cross functional collaboration teams.
- Strong team player or team lead and builds relationships with peers and cross-functionally at
- both global and local levels to drive performance.
- Fluent in additional languages desirable but not required.
- Ability to travel as needed in AREA (up to 35%).

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>)

Illinois

Clinical Research Associate II

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

PRIMARY FUNCTION/OBJECTIVE

To enable AbbVie’ s emergence as a world class R&D organization, the position anticipates and proactively solves study-related clinical site issues as they occur and initiates, recommends and communicates corrective action ensuring successful protocol level execution of CSM deliverables involving start-up, execution, and close-out of studies.

CORE JOB RESPONSIBILITIES

- Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol.
- Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.
- Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes.
- Overviews the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives. proactively manages the site and ensures action plans are put into place as needed to ensure compliance.
- Ensures regulatory inspection readiness at assigned clinical sites.
- Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
- Ensures safety and protection of study subjects through compliance with the study monitoring plan, AbbVie SOPs, ICH Guidelines, and applicable regulations.
- Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
- Manages investigator payments as per executed contract obligations.
- Negotiates investigator/ hospital agreements with stakeholders.
- Maintain and complete own expense reports as per local and applicable guidelines.
- Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.

Qualifications

- Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred.
- Site Monitoring Experience: Minimum 3 years.
- Experience in on-site monitoring of investigational drug or device trials is required.
- Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
- Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
- Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
- Ability to work, understand and follow work processes within the assigned function.
- Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity.
- Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated.
- Ability to use functional expertise and exercise good judgment.
- Demonstrated business ethics and integrity.

Additional Information

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>)

Other Non-US

Head of AI Transformation & Analytics, Medical Affairs + Health Impact

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

\*\*Position is based at our Mettawa, IL headquarters and will be on site Tuesdays through Thursdays.

The Head of AI Transformation & Analytics, Medical Affairs + Health Impact is a Senior Director who owns the advancement of MHI’s AI, analytics, and technology agenda. This transformational role will shift how MHI uses AI—from driving efficiency and productivity to shaping how treatment value is identified, demonstrated, and communicated to key internal and external stakeholders.

The role also owns MHI technology operations and keeps platforms, data flows, analytics products, dashboards, and AI-enabled workflows reliable, compliant, and aligned to business priorities.

Key Responsibilities

- Set MHI’s multiyear AI, analytics, and technology strategy, aligned to enterprise priorities and Golden Metrics.
- Build and deliver the MHI AI and analytics roadmap in alignment with enterprise digital, data, technology, and responsible AI strategies.
- Run MHI technology operations, including platform governance, systems maintenance, vendor/BTS partnership, releases, issue resolution, data quality, user enablement, continuity, and lifecycle management.
- Advance care gap analytics and insights transformation to align resources, priorities, and enterprise impact.
- Turn fragmented data into actionable insights for portfolio, field medical, scientific communications, and health impact decisions.
- Strengthen MHI’s enterprise value narrative through analytics, adoption metrics, and impact evidence.
- Scale AI-enabled workflows with clear value priorities, risk controls, human oversight, and impact measures.
- Build AI, analytics, and technology fluency through responsible AI practices, enterprise training, and human-AI collaboration.
- Embed responsible AI, data governance, and policy adherence with Legal, Regulatory, Privacy, Compliance, and Quality partners.
- Lead hub-and-spoke support for analytics, insights, technology operations, and workflows across global, area, affiliate, BTS, and enterprise partners.
- Define KPIs for AI adoption, enterprise value evolution, technology reliability, care gap closure, insight activation, efficiency, engagement quality, and health impact.
- Position MHI as a leader in responsible AI, analytics excellence, and technology-enabled Medical Affairs transformation.

Qualifications

- Advanced degree required; MD, PharmD, PhD, MPH, MS in Data Science, or related field preferred.
- 12+ years in Medical Affairs, Health Impact, Clinical Development, HEOR, Medical Excellence, Scientific Communications, analytics, digital transformation, or related fields.
- 7+ years leading enterprise digital, analytics, AI, technology operations, or transformation initiatives in matrixed organizations.
- Experience managing platforms, analytics products, roadmaps, vendors, service delivery, and governance.
- Strong knowledge of Medical Affairs operating models, evidence generation, medical communications, care gap analytics, insights, and health impact measurement.
- Experience leading in regulated, cross-functional governance environments.
- Ability to partner across Medical Affairs, R&D, Commercial, Data/Technology, and Legal/Compliance.
- Translates strategy into operating models, investments, plans, governance, and measurable outcomes.
- Influences senior leaders, aligns priorities, and leads teams through ambiguity, transformation, and adoption.

Preferred

- Experience with generative AI, large language models, AI governance, and responsible AI.
- Experience scaling AI workflows, agentic systems, analytics products, decision tools, or technology operations in pharma, healthcare, or life sciences.
- Knowledge of real-world evidence, structured content, care gap analytics, predictive analytics, omnichannel engagement, and insight activation.
- Experience leading healthcare or life sciences transformation programs.
- Familiarity with HCP engagement and scientific communications operations.

Success Measures

- Deliver the MHI AI and analytics roadmap with measurable global and affiliate adoption.
- Improve engagement, evidence generation, field effectiveness, care gap analytics, and insights activation through scalable AI and analytics.
- Sustain reliable, compliant MHI technology operations with clear service levels, governance, performance metrics, and adoption measures.

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>)

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

Purpose:

Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into

medicine for our patients and leveraging new advanced capabilities to drive industry leading

performance.

Partners with the investigator and site staff for meaningful and effective engagements positioning

AbbVie as the choice in clinical trials.

Focus on site clinical research that ensures appropriate conduct of the trial while driving

improvement in data integrity, compliance, overall study performance and customer experience.

Responsibilities:

- Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie’s positioning.
- Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.
- Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.
- Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.
- Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey.
- Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
- Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager.
- Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
- Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
- Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
- Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Ensures audit and regulatory inspection readiness at assigned clinical site at all times. Manages investigator payments as per executed contract obligations, as applicable.

Qualifications

- Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred.
- Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. Familiar with risk‐basedmonitoring approach, onsite and offsite monitoring.
- Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
- Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
- Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.
- Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
- Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
- Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
- Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues.
- Acts with integrity in accordance with AbbVie code of business conduct and leadership values.
- Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.

Additional Information

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>)

Senior Clinical Pharmacologist (Oncology)

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

Conceive and execute novel scientific research or development in Clinical Pharmacology that achieves projects and Clinical Pharmacology and Pharmacometrics (CPPM) goals. Generate new PK/PD proposals and lead those efforts. Investigate, identify, develop, and optimize new methods and techniques in PK/PD field. Act as a lead PK scientist in his/her area of expertise and critically evaluate relevant Clinical Pharmacology, PK/PD and regulatory advances and integrate this knowledge into research or development programs.

Responsibilities

Contribute to clinical development by supporting Phase 1-4 studies including study design, and clinical pharmacology strategy.

- Author regulatory documents including protocols, study reports, population PK reports, exposure-response analyses reports, relevant section of investigator brochures, common technical documents, white papers, and other similar documents.
- Conduct data analyses including non-compartmental analyses, modeling and simulation, literature data analyses.
- Participate and present at various departmental and cross functional teams such as study teams, clinical pharmacology and biopharmaceutics, clinical strategy team, Clinical Pharmacology leadership team, Journal club.
- Collaborate with scientific support from other Clinical Pharmacology functional groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams.
- Author scientific publications and present at scientific conferences.

Qualifications

- PhD with 0 years of experience, or Pharm D with 2+ years of experience in a relevant field, Master’s Degree or equivalent education and typically 8+ years of experience, Bachelor’s Degree or equivalent education and typically 10+ years of experience; (\*relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters)
- Excellent interpersonal skills
- Ability to interact externally and internally and perform in a team setting
- Demonstrates scientific acumen and has technical skills to perform the role
- Key Leadership Competencies:
  • Persistent and resilient finds the way to move good ideas forward
  • Uses mistakes, failure and reflection as vehicles for learning and improvement
  • Delivers business results while also positioning AbbVie for long-term success
  • Connects unrelated concepts, generates original or unique ideas
  • Influences colleagues to achieve cross-functional alignment

Additional Information

- 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>)

(Sr.) Medical Science Liaison, Aesthetics

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

- Provide scientific and medical leadership to build and maintain credible relationships with thought leaders, external experts, and key internal stakeholders of strategic importance to AbbVie.
- Establish a strong medical and scientific presence across aesthetics clinics by supporting research, educational, and scientific exchange initiatives, as well as responding to requests for medical and scientific information on products or therapeutic areas of interest to AbbVie.
- Support internal teams, including Sales and Marketing and members of the Affiliate Brand Team, in developing their scientific and technical expertise through scientific update presentations.
- Serve as a key scientific liaison within Medical Affairs by translating complex scientific and clinical information into clear, practical messages for diverse stakeholders, including thought leaders, healthcare professionals, and internal teams.
- Deliver credible and compliant presentations and facilitate discussions in one-on-one and group settings. Adapt communication styles to different audiences while ensuring scientific accuracy, clarity, and impact.
- Collaborate with multidisciplinary teams to support strategic planning, issue resolution, and the execution of medical and brand priorities, while demonstrating functional independence, maintaining scientific integrity, and achieving in-field medical metrics.
- Contribute to the identification and prioritization of thought leaders and external experts for collaborative activities, including advisory boards, congresses, symposia, and research initiatives, while ensuring high standards of scientific and educational integrity.
- Gather, synthesize, and communicate medical and field intelligence—including competitor insights, stakeholder feedback, and emerging data—to inform internal decision-making and cross-functional action.
- Attend relevant scientific meetings and congresses, and work with internal stakeholders to develop concise summaries and actionable insights that support AbbVie’s strategic priorities and initiatives.
- Provide scientific and technical support to key thought leaders, external experts, and internal medical and clinical teams for publications and scientific or medical communications of interest.

Qualifications

- Advanced degree (e.g., MD, PhD, or PharmD) in a scientific discipline. Experience in aesthetics, dermatology, plastic surgery, or a related therapeutic area is preferred.
- Experience working for a multinational pharmaceutical company, particularly in Medical Affairs, with a demonstrated ability to develop and maintain expert knowledge in the assigned therapeutic area. Familiarity with medical research and scientific communication is required.
- Demonstrated expertise in the scientific methods used in clinical research, as well as in the current legislative and regulatory requirements applicable to such research.
- Ability to learn comprehensively about new subject areas and environments and to manage multiple tasks in accordance with corporate priorities.
- Excellent written and verbal communication and presentation skills, with a demonstrated ability to develop and maintain strong, collaborative relationships with thought leaders, physicians, and multidisciplinary healthcare teams, while maintaining a high level of customer orientation.
- Strong written and spoken English skills are essential.
- Strong commitment to compliance with relevant rules and procedures, as well as to scientific quality and integrity.

Additional Information

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>)

Sr. RA Specialist

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

**Position:** Sr. RA Specialist

**Reports to:**  Regulatory Affairs Manager

**Location:**  Seoul, South Korea

**PRIMARY FUNCTION/OBJECTIVE**

To manage the preparation of regulatory submissions of company products in order to obtain the necessary regulatory approvals and to provide regulatory input on regulatory matters to company personnel.

**CORE JOB RESPONSIBILITIES**

- Developing RA strategies - assess timeline and lead development of regulatory strategy for new assets and line extensions based on the regulatory requirements as well as reflecting cross-functional team considerations. Support RA manager in developing regulatory strategies.
- Identifying and resolving regulatory issues and challenges that may arise during the product development, registration, or post-market phases
- Collaborating with cross-functional teams, such as R&D, Quality Assurance, and Marketing, to gather necessary information and support regulatory affairs activities.
- Participating in problem-solving discussions and providing input on regulatory matters to support decision-making processes.
- Set up timelines on managing variations in accordance with strategy
- Reviewing and evaluating product labeling, packaging, and promotional materials to ensure compliance with regulatory requirements.
- Conducting research on regulatory requirements and staying updated on changes in regulations and guidelines as Subject Matter Experts
- Evaluation of impact, implementation plan on the marketed products (hurdle, current situation) risk management, problem solving
- Product discontinuation/withdrawal/Marketing Authorization Transfer /co-promotion/co-marketing strategy reflecting feedback from internal stakeholders and global strategy
- Conducting thorough reviews of contract terms and conditions to identify any regulatory implications or requirements that need to be addressed.

Qualifications

**PREFERRED QUALIFICATIONS**

- Education: Bachelors or equivalent degree in appropriate discipline
- More than 5 years’ experience in a regulatory position in pharma industry
- Experience in Oncology or Orphan Drug Designation preferred
- Proficiency in both spoken and written English
- Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making.
- Good interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, and creativity. Demonstrated proactive and positive team player.
- Drives continuous improvement and simplicity in process and approach and enhances agility.

Additional Information

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>)

Director, Clinical Pharmacology (Immunology)

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

Communicates/presents key Clinical Pharmacology information/strategy to senior and executive management, regulatory agencies, and external peers. Supports strategic planning for drug development activities and projects to achieve departmental strategies, goals, and objectives. Utilizes scientific expertise to provide appropriate interpretation of data and relates implications of results to management. Serves as liaison to other departments/divisions for any study/project needs. Understands linkages across businesses and understands the impact of business decisions and solutions. May lead teams within Clinical Pharmacology and Pharmacometrics and accountable for effective performance of the teams.

Responsibilities

- Leads Clinical Pharmacology/PK/PD activities and multiple major projects. Assists R&D senior management in the selection of action plans that best meets drug development business objectives.
- Identifies issues and help with issue resolution. Conducts risk assessments and assists in development of contingency plans. Assures project remains in alignment with strategic objectives.
- Provides overall timelines to assess portfolio opportunities. Negotiates with other functional areas on project outcomes and deliverables to meet conflicting demands (time, cost, quality/performance).
- Provides scientific and strategic consultation to R&D, Regulatory, and all levels of management on critical decisions and development plans.
- Responsible for evaluating technical, scientific aspects of all AbbVie projects along with CLINICAL PHARMACOLOGY management. Reviews clinical protocols and scientific reports for regulatory filings and anticipates regulatory questions. Leads CLINICAL PHARMACOLOGY regulatory documents writing, submission and response to Regulatory agency comments.
- Independently conducts due diligence assessments, summarizes results and represents CLINICAL PHARMACOLOGY on business development teams.
- Identifies and develops process improvement initiatives and reviews recommendations with management for approval and sponsorship.
- Contribute to development of departmental goals. Influences strategic PK/PD decisions for the department.
- Performs functions and responsibilities with the highest regard for quality and timeliness. Maintains up-to-date knowledge of PK/PD data analysis, modeling and simulation methods and software.
- May manage personnel including development, mentoring, and effective delegation.

Qualifications

- PhD with typically 7+ years of experience or Pharm D with typically 9+ years of experience in a relevant field, MS or equivalent education with typically 15+ years of experience; BS or equivalent education and typically 17+ years of experience; (\*relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters)
- Excellent interpersonal skills
- Knowledge and experience in multiple therapeutic and/or functional areas
- Experience across range of development phases
- Knowledge of AbbVie and Pharma drug development processes
- Must have demonstrated leadership competencies in PK/PD, Biopharmaceutics, and Pharmacometric activities from planning, implementation through completion across multiple projects
- Scientific project leadership or related experience
- Project management skills such as scope management, progress tracking/driving as well as time management
- Participates in initiatives and advancement of CLINICAL PHARMACOLOGY
- Key Leadership Competencies:
  • Knows the business and the cross-functional contributions needed to deliver results
  • Persistent and resilient finds the way to move good ideas forward
  • Acts respectfully yet courageously
  • Connects unrelated concepts, generates original or unique ideas
  • Influences colleagues to achieve cross-functional alignment
  • Communicates openly and honestly with all colleagues
  • Manages conflict and difficult conversations in a constructive transparent way

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>)

Massachusetts

Senior Analyst, Clinical Photography and Imaging - HYBRID

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

AbbVie Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences.

Responsibilities

Ensures that the requirements of each study protocol are reflected in systems designs and that common data standards are used

- Ensures that systems are specified to optimize on functionality, end user experience, and data flow
- Accountable for the on-time design and delivery of new clinical systems, integrations between systems, as well any required changes to clinical systems (e.g., EDC, IRT,). Utilizes project management tools to track study progress and plan work. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions
- Ensures that TA- and program-level consistency is achieved
- Interacts with and influences DSS and cross-functional team members to achieve program and study objectives. Ensures that assigned work product is synchronized with upstream and downstream dependencies
- Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development
- Responsible for coaching and mentoring Data Science Associates
- Participates in DSS and cross-functional innovation and process improvement initiatives

Qualifications

- Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Masters preferred
- Must have 3+ years of clinical technology experience (e.g., EDC, IRT, ePRO) or 5+ years of experience in a similar technical role or in a clinical development role. Experience with common industry design and development tools preferred
- Demonstrated understanding of clinical trial process
- Knowledge of CDASH and SDTM
- Demonstrated ability to influence of others without direct authority
- Demonstrated effective communication skills
- Demonstrated effective analytical skills

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 short-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>)

New Jersey

Head of Asset in GU, Oncology Clinical Development

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

Manages other Medical and/or Scientific Directors and leads the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy.

- Personally or through a direct report, leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel.
- Has overall responsibility for leading and mentoring clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols assigned.
- Has primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
- Manages one level of Medical and Scientific Directors (typically 2 to 4) and/or Clinical Scientists. This responsibility involves direct oversight of clinical development activities and/or management of personnel who may be working on other projects. Responsible for hiring, onboarding, mentoring, training, and supporting career development of these individuals.
- May chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In this capacity, responsibilities may include supervision of matrix team members and serving as the Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs).
- Serves as the in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
- Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
- Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings.
- Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

Qualifications

- Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment required. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
- At least 7 years (9+ years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
- Ability to run a complex clinical research program independently.
- Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead and manage through influence.
- Demonstrated commitment to training and development of junior-level staff, using best judgment to assure that they work with an appropriate level of autonomy.
- Ability to interact externally and internally to support a global scientific and business strategy.
- Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.
- Must possess excellent oral and written English communication skills
- Ability to exercise judgment and address complex problems and create solutions across multiple projects.

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 thisposting 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 anduntil 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>)

Scientific Director / Senior Medical Director, Medical Affairs - Global Oncology Pipeline

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 Medical Affairs organization provides patients, healthcare providers, and payers everywhere with the practical and clinically relevant information and solutions they need to use AbbVie products safely and effectively, throughout the product lifecycle and the patient’s journey.

The Scientific Director / Senior Medical Director, Medical Affairs - Global Oncology Pipeline provides medical and scientific input into core strategic and operational pipeline medical affairs activities for the prostate cancer portfolio such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, scientific communications, and value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities). Works closely with sales, marketing, and commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical affairs, marketing activities (promotional material generation and product launches) and market access.

This position can be based at our Mettawa, IL, Florham Park, NJ, or South San Francisco, CA locations and will follow a hybrid schedule of Tuesdays-Thursdays in office.

**Responsibilities**

- Leads medical input into disease area strategy and asset strategies within the prostate cancer oncology pipeline portfolio.
- Leads pipeline medical evidence generation strategy and execution including company sponsored studies, research collaborations and investigator initiated studies.
- Provides in-house medical expertise for the disease area and assets, coordinating appropriate scientific activities with internal and external stakeholders as they relate to ongoing programs. May participate in due diligence or other business development activity as required by program needs, and contribute to translational strategy in partnership with discovery colleagues.
- Acts as a medical interface and actively solicits insights and opinion through the development and execution of medical expert engagement strategies, partnering with clinical development, commercial, access, area and affiliate colleagues to ensure that broad perspectives both internally and externally are incorporated into strategies and plans as appropriate.
- Leads creation of early scientific narratives, messaging, and communications activities including congress planning, medical education, publication strategies and plans.
- May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia. Assists with the scientific review, development, approval, execution, and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
- May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e., commercial, clinical operations, discovery, statistics, regulatory, etc…) as they relate to on-going medical affairs projects. Serves as the scientific team interface for key regulatory discussions.
- Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource.
- Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.

Qualifications

*Position will be commensurate with experience.*

**Scientific Director Qualifications:**

- Advanced Degree PhD or PharmD. Additional post doctorate experience highly preferred.
- Typically, 10-15 years of experience in the pharmaceutical industry or equivalent
- 7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred.
- Substantial knowledge of relevant therapeutic area required. Direct experience and knowledge in prostate cancer strongly preferred.
- Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
- Proven leadership skills in a cross-functional global team environment.
- Must possess excellent oral and written English communication skills.

**Senior Medical Director Qualifications:**

- Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D). Relevant therapeutic specialty in an academic or hospital environment preferred. Completion of residency and/or fellowship is preferred.
- Minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 3+ years of experience is preferred.
- Substantial knowledge of relevant therapeutic area required. Direct experience and knowledge in prostate cancer strongly preferred.
- Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
- Proven leadership skills in a cross-functional global team environment
- Ability to interact externally and internally to support global business strategy.
- Must possess excellent oral and written English communication skills.

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>)

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

Adicet Bio, Inc.

CLINICAL TRIAL MANAGER

**JOIN US!**

Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at [https://www.adicetbio.com](<https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.adicetbio.com&esheet=54175567&newsitemid=20250108585728&lan=en-US&anchor=https%3A%2F%2Fwww.adicetbio.com&index=1&md5=9d942dbcdb299f0c9fe719a48148cd0e>).

**CLINICAL TRIAL MANAGER**

As a Clinical Trial Manager you will be responsible for the operational planning, execution, oversight, and delivery for assigned clinical trials. The Clinical Trial Manager will ensure studies are conducted in compliance GCP/ICH, company Standard Operating Procedures (SOPs), study timelines and budget. You will work cross functionally within the Adicet Bio team as well as with study sites, CROs and other vendors.

**Key responsibilities:**

- Work closely with the Clinical Operations team to support all aspects of global clinical studies
- Take a leadership role in certain site and study management activities including: ICFs, site activations, monitoring reports and study plan review and creation
- Leading and presenting at Study Execution Team meetings
- Collaborate with cross functional team members to independently address routine study issues
- Assist with CRO and/or vendor oversight and management to ensure milestones are achieved
- Identify issues for escalation, participate in problem solving and implementation of risk mitigation
- Participate in departmental and corporate initiatives
- Perform co-monitoring visits as needed to provide oversight during site qualification, site initiation, routine monitoring, and close-out visits
- Generate and maintain reports, listings, and trackers as needed
- Ensure close tracking of site enrollment and related metrics
- Establish and manage clinical trial master files (TMF).

**Qualifications:**

- BS or higher degree in science, nursing (RN or BSN), or equivalent discipline
- A minimum of 4 years of clinical research experience in biotechnology, pharmaceutical, or CRO industry
- Experience supporting studies in a fast-paced environment
- Success in working with CROs and vendors
- Excellent communication skills and ability to achieve milestones in a team environment
- Strong working knowledge of FDA, ICH Guidelines, and GCPs governing the conduct of clinical trials
- Experience with managing studies in electronic data capture systems
- Experience with project, vendor, contract, and clinical research staff management
- Experience with Institutional Review Board (IRB) preparations and submission
- Ability to work independently, collaboratively and manage deadlines
- Knowledge in molecular diagnostics or laboratory skills is a plus

Adicet fosters a collaborative, high-performing environment by prioritizing in-person engagement. To enhance teamwork and communication, employees are required to be onsite **at least three days per week (Tuesday–Thursday mandatory)** , with some roles requiring full-time onsite presence.

Pay Range

$131,000 - $181,000 USD

Adicet fosters a collaborative, high-performing environment by prioritizing in-person engagement. To enhance teamwork and communication, employees are required to be onsite **at least three days per week (Tuesday–Thursday mandatory)** , with some roles requiring full-time onsite presence.

At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting autoimmune diseases and cancer.

We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.

To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.

We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 13 company holidays, paid end-of-year winter break, vacation, sick time, and paid parental leave.

Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company-subsidized lunches (delivered onsite daily) and fully stocked breakrooms.

Adicet is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

Senior Director, Immunology Translational & Clinical Research

CSL Behring is a global biopharmaceutical leader committed to developing innovative therapies for patients with rare and serious diseases. Our Immunology franchise is advancing a diverse pipeline targeting autoimmune and inflammatory conditions across rheumatology, neuroimmunology, and rare dermatology.

Could you be our next Senior Director, Immunology Translational & Clinical Research? The job is in our Waltham MA or Melbourne Australia Office. This is a hybrid position and is onsite three days a week. You will report to the Research Therapeutic Area Lead, Immunology/Transplant and Vaccines.

You will work hands-on as a clinical subject matter expert embedded with the research team, bringing a true bench-to-bedside mindset rather than a purely advisory role. Partnering day-to-day with the Research Therapeutic Area Lead and bench scientists, you will roll up your sleeves to prioritize therapeutic targets, shape clinical development plans, and directly translate mechanistic and preclinical data into first-in-class or best-in-class immunology therapies. You will be an active, present partner from early ideation through first-in-disease, working shoulder-to-shoulder with discovery research, translational medicine, clinical development, and business development to advance CSL Behring's immunology pipeline.

This is a high-impact role directly influencing portfolio prioritization, target assessment, and early clinical program design through active day-to-day collaboration, not just strategic oversight.

**RESPONSIBILITIES:**

Scientific Leadership & Disease Area Expertise

- Act as the hands-on clinical subject matter expert and internal champion for one or more immunology disease areas, with rheumatology expertise strongly preferred; neuroimmunology and/or dermatology also considered
- Bring a bench-to-bedside mindset, working directly with bench scientists to translate mechanistic understanding of immune pathology into actionable therapeutic hypotheses and target identification strategies
- Sit alongside the research team as an active partner in prioritizing therapeutic targets and building out clinical development plans, not just reviewing decisions after the fact
- Stay personally close to the competitive landscape, emerging science, and unmet medical need across assigned disease areas, digging into primary data and literature directly
- Represent CSL Behring at key scientific conferences, advisory boards, and KOL meetings; build and actively maintain a hands-on network of thought leaders, clinical investigators, and academic collaborators

**Pipeline Development & Asset Progression**

- Get directly involved end-to-end in asset progression from ideation through first-in-disease designation, personally working through scientific rationale, translational endpoints, patient population selection, and clinical strategy alongside the project team
- Lead or co-lead target and asset evaluation activities, personally reviewing preclinical and clinical data packages, mechanism-of-action assessments, and translational feasibility analyses line by line
- Partner with development colleagues on IND-enabling studies, proof-of-concept study designs, and Phase 1/1b protocol development, working directly with study teams
- Be the go-to immunology clinical subject matter expert embedded with discovery colleagues day-to-day, bridging preclinical science and clinical relevance to directly shape program design and go/no-go decisions
- Work hands-on with discovery and translational teams to define disease-relevant biomarkers, pharmacodynamic readouts, and patient stratification strategies for early clinical programs
- Actively contribute to R&D programs as a working subject matter expert, providing direct, in-the-weeds guidance on the clinical development pathway
- Partner closely and continuously with the Research Therapeutic Area Lead, RPLs, and Immunology core team members to prioritize therapeutic targets and personally help maintain a best-in-class immunology portfolio

Cross-Functional Collaboration & Strategic Input

- Partner directly with Business Development colleagues on in-licensing, and partnering opportunities within immunology, on clinical and scientific due diligence
- Contribute to drafting Target Product Profiles (TPPs), integrated development plans, and portfolio reviews in partnership with clinical, commercial, and research colleagues
- Provide disease area expertise to regulatory submissions, clinical study reports, and scientific communications

Qualifications

- MD or DO with clinical experience in rheumatology (preferred); neuroimmunology and/or dermatology also acceptable
- Demonstrated bench-to-bedside research mindset with hands-on, working-level experience translating preclinical and translational science into clinical strategy, not purely oversight experience
- Experience in drug development within a biotech, pharmaceutical, or academic environment
- Demonstrated hands-on experience in preclinical to first-in-disease (or equivalent early clinical milestone) programs in immunology
- Deep scientific expertise in the immunological mechanisms underpinning autoimmune and inflammatory diseases
- Established and active network in drug development with recognized relationships across rheumatology, neuroimmunology, and/or dermatology communities
- Proven track record of evaluation of preclinical and clinical assets, including direct target assessment, data package review, and go/no-go decision-making, plus active support of BD due diligence and TPP drafting
- Strong ability to synthesize complex scientific data and communicate strategy clearly to diverse audiences including senior leadership

The expected base salary range for this position at hiring is $338,000 - $390,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the time of this posting in MA. 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.

\#LI-HYBRID

**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.cslbenefits.com/csl/candidates>).

**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>).

Insmed Incorporated

Manager, Field Medical (MSL)

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 Field Medical Japan develops and maintains professional relationships with external healthcare practitioners to provide comprehensive medical and scientific support for Insmed assigned therapeutic areas. Engages appropriately in scientific exchanges around product information, disease education, and research ideas/activities with physicians and ancillary healthcare professionals regarding current and future therapies in development or commercialized by Insmed.

Works closely with Insmed personnel to ensure adequate training, access to educational resources and alignment between Insmed’s Medical Affairs plans and the unmet needs of the patients and healthcare professionals.

**What You'll Do:**

- Identify and classify thought leaders, investigators and healthcare professionals (HCP) in assigned areas of therapeutic interest, and develop and maintain professional relationships with them to ensure timely, effective and appropriate communication of current and emerging medical and scientific information on Insmed products support of appropriate prescribing and improved patient care and outcomes
- Present data and introduce scientific literatures/ information on Insmed area of interest to HCPs including physicians, academic institutions, researchers, and allied health care professionals, consistent with all Insmed policies and procedures
- Execute Advisory Board and other scientific forums to bring back critical customer insights and feedback and provide support to the medical execution (Abstracts, posters, publications)
- Conduct scientific exchanges related to Insmed area of interest at Scientific Societies and Academic Medical Centers and ensure that healthcare organizations have the latest information on Insmed products resulting in appropriate prescribing, and improved patient care and outcomes
- Serve as a local medical and scientific resource to Insmed for product planning, clinical insights and intelligence
- Capture, synthesize and deliver HCP derived scientific insights to Insmed
- Deliver mentoring to internal Insmed colleagues about Insmed products and its relevant diseases
- Support Insmed MA sponsored clinical studies to keep timelines (site and investigators selection, communication with investigators) in collaboration with Medical Director and CRO
- Respond to investigator inquiries and support investigator-initiated studies (IIS) submissions through appropriate internal processes
- Discuss necessity and possibility of data generation with HCPs and motivate them to solve unmet medical needs relating Insmed products and its relevant diseases

**Who You Are:**

- Minimum 5 years of experience in a biotechnology or pharmaceutical company and minimum 3 years of experience as MSL, working in Medical Affairs in a global setting including experience launching global products
- Must have experience in respiratory disease.
- Prior experience in supporting a product launch and Health outcomes, pharmacoeconomics, population-based health management experience are preferred
- Demonstrated understanding of legal, regulatory and compliance policies. Requires strong business acumen with strategic thinking and highly effective analytic skills. An uncompromising ethical standard and level of conduct are essential.
- Ability to quickly understand and dialogue on subjects that are at the interface between medicine and policy which are relevant to Insmed’s areas of interest (disease condition, patient reported outcomes, competitive pipelines and lifecycle plans, medical and pharmacy benefits, quality programs, etc.) is needed.
- Ability to connect the “internal” science to the “external” unmet medical need and communicate complex clinical data in a user-friendly way.
- Understanding of biomedical research and drug development and the ability to communicate data in an impactful way
- 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. 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. Highly organized with a strong attention to detail, clarity, accuracy and conciseness
- Master’s degree in Pharmacy, Life Science or equivalent required, PhD is preferred
- Must successfully exhibit Insmed’s five (5) core corporate competencies of: Collaboration, 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. Non-smoker

**Travel Requirements**

This position involves frequent domestic/international travel up to 70

**Life at Insmed**

**_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.*

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.*

Executive Assistant, Global Clinical Development & Patient Advocacy

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 Executive Assistant, Global Clinical Development & Patient Advocacy on the Clinical Development team to help us expand what’s possible for patients with serious diseases. Reporting to the Global Head of Clinical Development – Respiratory, you’ll also provide support to the VP, Patient Advocacy, and VP, Disease Area Head – Gene Therapy and other executives. The ideal candidate will be experienced in handling a wide range of administrative and executive support related tasks and will be able to work independently and proactively with little or no supervision.

**What You'll Do:**

In this role, you’ll have the opportunity to manage multiple calendars, schedule meetings, make travel arrangements, prepare expense reports, take notes and summarize meetings. You’ll also:

- Serve as an administrator to appropriate Team Channels, uploading files, keeping them up to date, and keeping the internal stakeholders informed
- Act as the main point of contact and coordination for all department Purchase Orders, statements of work, and invoice tracking and following the Procure to Pay process
- Proactively identify needs and gaps, and accordingly making proposals for improvement
- Have accountability for attention to detail and timely follow-up on assigned tasks
- Be responsible for coordinating invites, logistics, and execution of Townhalls and other team engagement events
- Support department projects and initiatives
- Develop, format, proofread and maintain upkeep of general Excel files, Word documents and PowerPoint presentations
- Coordinate with Legal and Compliance on managing Expert Service Agreements and any other contracts
- Have accountability for independently coordinating team meetings including logistics, food, travel, and other arrangements
- Set up, maintaining files and general correspondence

**Who You Are:**

You have a minimum of a High School diploma, with a Bachelor's degree preferred and a minimum of 5 years of Executive Assistant experience required, preferably supporting senior leaders in the Pharmaceutical or Biotech industry.

You are or also have:

- Experience supporting simultaneously multiple executives and ability to manage their needs as required
- Desire to learn and take on challenging assignments
- Ability to exercise discretion in dealing with confidential or sensitive matters
- Ability to handle multiple projects simultaneously while remaining flexible to shift priorities quickly
- Ability to excel in a fast-paced environment, sometimes under pressure, with a high level of professionalism is crucial to this role
- Professional etiquette in all aspects of the job
- Excellent calendar management skills
- Excellent communication skills (verbal and written).
- High level of organization with a strong attention to detail, clarity, accuracy and conciseness.
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).

**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**

Minimal travel expected

\#LI-TB1

\#LI-Hybrid

**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.*

Manager, Project Management - Large Molecule

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 – Large Molecules on the Project and Strategy Management team to help us expand what’s possible for patients with serious diseases. Reporting to the Senior Director, Project & Strategy Management, you’ll drive large molecule (biologics) pipeline projects from research transition through process development, characterization, registration, and commercial readiness; leading cross-functional CMC teams across drug substance and drug product workstreams, and partnering with CDMOs to ensure high-quality delivery.

**What You'll Do:**

In this role, you’ll have the opportunity to Lead large molecule project teams, internally and with CDMO/external partners, fostering collaboration and accountability. You’ll also:

- Guide biologics programs from Research through Technical Operations, tech transfer, regulatory submission, and launch
- Integrate across Drug Substance, Drug Product, Analytical Development, Quality, and Regulatory to align on project goals
- Drive structured frameworks for tech transfer, process characterization/validation, and comparability studies
- Identify and mitigate biologics-specific risks (e.g., cell line stability, viral safety, supply constraints)
- Own project planning, milestone tracking, and communication across key biologics milestones
- Represent Technical Operations in cross-functional and governance meetings
- Maintain communication and relationships with CDMOs and external partners to ensure alignment on timelines and deliverables
- Support budget planning and resource forecasting for biologics activities
- Contribute to a high-performing, people-centered project management culture

**Who You Are:**

You have a bachelor’s degree along with 5 years of experience in of project management experience in large molecule/biologics development.

You are or you also have:

- Working knowledge of upstream/downstream processing and drug product/fill-finish
- Strong people and team leadership skills, with the ability to motivate and guide cross-functional teams without formal authority
- Proficiency with project management tools (e.g., MS Project, Excel, PowerPoint)

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

- PMP certification and experience with mAbs, recombinant proteins, or cell/gene therapy preferred

**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 global travel (up to 20%)

\#LI-HYBRID

**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 Director, Clinical Development

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 Director, Clinical Development on the Clinical Development team to help us expand what’s possible for patients with serious diseases. You’ll serve as a clinical leader responsible for supporting two primary activities. First, the role provides clinical evaluation of potential in-licensing or acquisition opportunities coordinated and led by Insmed’s Business Development organization. Second, the role supports cross-functional discussions with Insmed discovery research platforms as molecules advance beyond the Late Lead Optimization milestone that may have potential development in immunological disorders apart from respiratory diseases and as cush there is an expectation that the physician will possess sufficient breadth of experience to contribute meaningfully to initial evaluations across multiple immunological disorders; leveraging external medical experts as needed.

**What You'll Do:**

In this role, you’ll have the opportunity to provide clinical input into the overall assessment of external molecules as a member of Due Diligence teams. You’ll also:

- Contribute clinical input to cross-functional planning for molecules emerging from Insmed discovery platforms at the Late Lead Optimization stage.
- Serve, as needed, on transition teams for molecules that are in-licensed, acquired, or partnered.
- Maintain awareness of emerging science, competitive landscapes, and evolving global standards of care across relevant disease areas.
- Partner with Global Clinical Development functions to monitor benefit–risk profiles, manage safety signals, and support regulatory communications or meetings for any ongoing studies associated with in-licensed or acquired assets that are in transition to early GPT or GPT formation.
- Collaborate with Global Clinical Development functions to support the design of potential clinical studies and Clinical Development Plans (CDPs) that meet global ICH-GCP, ethical, and regulatory standards.
- Build and maintain strong partnerships with external medical experts supporting development programs for in-licensed or acquired assets that are in transition to earl GPT or GPT formation, as well as emerging programs from Insmed discovery platforms.

**Who You Are:**

You have an MD, MD/PhD, or equivalent medical training is required, with board certification in an internal medicine specialty that includes immunological disorders such as Rheumatology or Transplantation. Drug development experiences will be considered as relevant, along with at least 7 years of clinical development experience in biotech or pharmaceutical settings, with meaningful drug development experience across modalities, including oral small molecules and biologics; experience with combination drug–device products preferred. Original NDA, MAA, and J-NDA experience is a plus. You are or also have:

- Demonstrated leadership in the design, execution, and interpretation of global Phase 1–2a clinical programs; experience with combination drug–device development and later-stage programs is a plus.
- Strong understanding of global regulatory pathways and expectations, including FDA, EMA, and PMDA.
- Proven ability to lead and influence effectively within cross-functional, matrixed organizations.
- Excellent written and verbal communication skills, with the ability to engage scientific, regulatory, and executive stakeholders.
- Strategic thinking and sound clinical judgment
- High scientific and analytical rigor
- Strong influence and decision-making skills in matrixed environments
- Excellence in communication and external engagement
- Ability to navigate ambiguity and make timely, balanced decisions
- Effective collaboration across global, cross-functional teams

**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/international travel (approximately 10%)

\#LI-TB1

\#LI-Remote

**Pay Range:**

$273,000.00-372,000.00 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, 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.*