Global Development Lead, Internal Medicine (MD, Sr. Director)
Pfizer
August 31, 2026
Remote friendly (Pearl River, NY)
United States
Clinical Research and Development
Role Summary
The Global Development Lead (GDL) is the single clinical point of accountability for clinical development for assigned asset(s) in Internal Medicine at Pfizer. Leads cross-functional Clinical Development Teams to design, execute, and interpret studies supporting worldwide regulatory submissions.
Responsibilities
- Lead creation and endorsement of the Clinical Development Plan and associated protocol design documents.
- Partner with the Medicine Team Lead to negotiate tradeoffs, milestones, timelines, and budget.
- Own a comprehensive clinical development plan to secure a global (incl. China and Japan) approval and reimbursement strategy, including pediatric investigation/study plans and protocol design.
- Provide product/program input to target product profile(s).
- Drive innovative, bold decisions across clinical development; develop enabling strategies (digital/innovation and patient engagement).
- Partner with trial clinicians on governance reviews (incl. Sci/Ops) and provide therapy/category clinical development strategy.
- Provide therapy area/indication expertise for clinical data review (e.g., CRF design, signal interpretation, AE contextualization).
- Provide specialized medical monitoring support if required.
- Contribute to trial-level statistical analysis plans, TLFs, listings/figures, and database releases with statistics/programming.
- Develop submission deliverables (IAP, IARP, submission TLFs), including SCE and SCS; support clinical data interpretation/communication.
- Review/approve submission-level safety narrative plan; support product label development/maintenance.
- Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/patient advocates) to generate insights for development strategy and PDD development.
- Provide regulatory submission support (DSUR, PBRER), disclosure deliverables, and product defense; ensure compliance with SOPs and regulatory standards.
Basic Qualifications
- MD or DO.
- 8+ years of relevant clinical R&D experience; extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Strongly preferred: cardiologist with cardiovascular outcome trials or large complex global development programs.
- Demonstrated clinical/medical, administrative, and project management; effective verbal/written communication.
- Demonstrated experience managing/training large clinical development teams; designing/launching large teams preferred.
Competency Requirements (selected)
- Medical/scientific excellence; leadership; influencing; conflict management; team building; accountability; ability to work in complex matrix environments.
Non-standard/Work Environment
- Up to 30% travel; hybrid role (on-site ~2.5 days/week).
Benefits/Compensation
- Eligible for Pfizer Global Performance Plan bonus target and long-term incentive; comprehensive benefits including 401(k), paid time off, caregiver/parental/medical leave, and health coverage.
Application Instructions
- Not specified in the provided text.
The Global Development Lead (GDL) is the single clinical point of accountability for clinical development for assigned asset(s) in Internal Medicine at Pfizer. Leads cross-functional Clinical Development Teams to design, execute, and interpret studies supporting worldwide regulatory submissions.
Responsibilities
- Lead creation and endorsement of the Clinical Development Plan and associated protocol design documents.
- Partner with the Medicine Team Lead to negotiate tradeoffs, milestones, timelines, and budget.
- Own a comprehensive clinical development plan to secure a global (incl. China and Japan) approval and reimbursement strategy, including pediatric investigation/study plans and protocol design.
- Provide product/program input to target product profile(s).
- Drive innovative, bold decisions across clinical development; develop enabling strategies (digital/innovation and patient engagement).
- Partner with trial clinicians on governance reviews (incl. Sci/Ops) and provide therapy/category clinical development strategy.
- Provide therapy area/indication expertise for clinical data review (e.g., CRF design, signal interpretation, AE contextualization).
- Provide specialized medical monitoring support if required.
- Contribute to trial-level statistical analysis plans, TLFs, listings/figures, and database releases with statistics/programming.
- Develop submission deliverables (IAP, IARP, submission TLFs), including SCE and SCS; support clinical data interpretation/communication.
- Review/approve submission-level safety narrative plan; support product label development/maintenance.
- Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/patient advocates) to generate insights for development strategy and PDD development.
- Provide regulatory submission support (DSUR, PBRER), disclosure deliverables, and product defense; ensure compliance with SOPs and regulatory standards.
Basic Qualifications
- MD or DO.
- 8+ years of relevant clinical R&D experience; extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Strongly preferred: cardiologist with cardiovascular outcome trials or large complex global development programs.
- Demonstrated clinical/medical, administrative, and project management; effective verbal/written communication.
- Demonstrated experience managing/training large clinical development teams; designing/launching large teams preferred.
Competency Requirements (selected)
- Medical/scientific excellence; leadership; influencing; conflict management; team building; accountability; ability to work in complex matrix environments.
Non-standard/Work Environment
- Up to 30% travel; hybrid role (on-site ~2.5 days/week).
Benefits/Compensation
- Eligible for Pfizer Global Performance Plan bonus target and long-term incentive; comprehensive benefits including 401(k), paid time off, caregiver/parental/medical leave, and health coverage.
Application Instructions
- Not specified in the provided text.