Global Development Lead, Internal Medicine (MD, Sr. Director)
Pfizer
August 31, 2026
Remote friendly (Pennsylvania, United States)
United States
Clinical Research and Development
Role: Global Development Lead (GDL), Clinical Development (Internal Medicine/Obesity portfolio)
Responsibilities:
- Lead cross-functional clinical development for assigned asset(s), including study design, execution, and interpretation for worldwide regulatory submissions.
- Create and gain endorsement for the Clinical Development Plan and associated protocol design documents.
- Own global clinical development strategy to secure approval and reimbursement (including China and Japan) and develop pediatric investigation/study plans with trial clinicians.
- Provide input for target product profile(s); develop clinical development enabling strategies (including digital/innovation and patient engagement).
- Partner on governance reviews; provide therapy area/indication expertise (CRF design, signal interpretation, AE contextualization).
- Support statistical analysis deliverables (TFLs, table-listings-figures, database release) and submission deliverables (IAP/IARP/TLFs; SCE/SCS).
- Support label development/maintenance; interpret and communicate clinical data; review/approve submission safety narrative plans.
- Provide regulatory submission support (DSUR, PBRER) and product defense; ensure compliance with SOPs and regulatory standards.
- Engage external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients).
- May provide specialized monitoring support; review IIR proposals.
Qualifications:
- MD or DO.
- 8+ years clinical R&D experience; extensive knowledge of clinical development, ICH/GCP, global/regional regulation, and adverse event management.
- Cardiologist (strongly preferred) with cardiovascular outcome trials or large complex global development programs.
Skills/Experience:
- Proven clinical/medical, project, and administrative leadership; ability to manage/training large teams; influence in a matrix.
Work & benefits:
- Up to 30% travel; hybrid (on-site ~2.5 days/week). Relocation support available.
- Eligible for Global Performance Plan bonus (25% target) and long-term incentives; comprehensive benefits (401(k), paid leave, medical/dental/vision).
Responsibilities:
- Lead cross-functional clinical development for assigned asset(s), including study design, execution, and interpretation for worldwide regulatory submissions.
- Create and gain endorsement for the Clinical Development Plan and associated protocol design documents.
- Own global clinical development strategy to secure approval and reimbursement (including China and Japan) and develop pediatric investigation/study plans with trial clinicians.
- Provide input for target product profile(s); develop clinical development enabling strategies (including digital/innovation and patient engagement).
- Partner on governance reviews; provide therapy area/indication expertise (CRF design, signal interpretation, AE contextualization).
- Support statistical analysis deliverables (TFLs, table-listings-figures, database release) and submission deliverables (IAP/IARP/TLFs; SCE/SCS).
- Support label development/maintenance; interpret and communicate clinical data; review/approve submission safety narrative plans.
- Provide regulatory submission support (DSUR, PBRER) and product defense; ensure compliance with SOPs and regulatory standards.
- Engage external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients).
- May provide specialized monitoring support; review IIR proposals.
Qualifications:
- MD or DO.
- 8+ years clinical R&D experience; extensive knowledge of clinical development, ICH/GCP, global/regional regulation, and adverse event management.
- Cardiologist (strongly preferred) with cardiovascular outcome trials or large complex global development programs.
Skills/Experience:
- Proven clinical/medical, project, and administrative leadership; ability to manage/training large teams; influence in a matrix.
Work & benefits:
- Up to 30% travel; hybrid (on-site ~2.5 days/week). Relocation support available.
- Eligible for Global Performance Plan bonus (25% target) and long-term incentives; comprehensive benefits (401(k), paid leave, medical/dental/vision).