Global Development Lead, Internal Medicine (MD, Sr. Director)
Pfizer
August 13, 2026
Remote friendly (Pearl River, NY)
United States
Clinical Research and Development
Role Summary
The Global Development Lead (GDL) is the clinical point of accountability for clinical development for assigned Internal Medicine asset(s). Leads a cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) 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.
- Ensure delivery of the clinical program within agreed timelines and budget; negotiate tradeoffs and milestones with the Medicine Team Lead.
- Create global development plans to secure approval and reimbursement (including China and Japan), including pediatric investigation/study plan and protocol documents.
- Provide therapy area/indication expertise (e.g., CRF design, signal interpretation, adverse event contextualization) and support clinical governance reviews.
- Develop submission deliverables (IAP, IARP, submission TLFs, SCE, SCS); ensure interpretation/communication of trial data and review/approve safety narrative plans.
- Support target product profiles and regulatory activities (labels, core data sheets, Investigator Brochures, DSUR, PBRER, Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports).
- Engage external stakeholders (e.g., Ad boards, Steering Committees, DMC, adjudication committees, patients/patient advocates).
- Ensure compliance with internal SOPs and external regulatory standards.
Basic Qualifications / Required Skills
- MD or DO.
- Endocrinologist or internal medicine physician with cardiometabolic late-stage development experience, including type 2 diabetes.
- 8+ years clinical research and development experience; deep knowledge of global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated clinical/medical, administrative, and project management skills; strong verbal/written communication; experience managing/training large clinical teams.
Preferred
- Experience designing and launching large teams.
Travel/Work & Benefits
- Up to 30% travel; hybrid (on-site ~2.5 days/week).
- Relocation support available.
- Base salary range (US): $274,500–$457,500; bonus target 25% of base; eligible for long-term incentive. Comprehensive benefits including 401(k) with matching, paid leave, and medical/dental/vision.
Application instructions
- None provided in the text.
The Global Development Lead (GDL) is the clinical point of accountability for clinical development for assigned Internal Medicine asset(s). Leads a cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) 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.
- Ensure delivery of the clinical program within agreed timelines and budget; negotiate tradeoffs and milestones with the Medicine Team Lead.
- Create global development plans to secure approval and reimbursement (including China and Japan), including pediatric investigation/study plan and protocol documents.
- Provide therapy area/indication expertise (e.g., CRF design, signal interpretation, adverse event contextualization) and support clinical governance reviews.
- Develop submission deliverables (IAP, IARP, submission TLFs, SCE, SCS); ensure interpretation/communication of trial data and review/approve safety narrative plans.
- Support target product profiles and regulatory activities (labels, core data sheets, Investigator Brochures, DSUR, PBRER, Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports).
- Engage external stakeholders (e.g., Ad boards, Steering Committees, DMC, adjudication committees, patients/patient advocates).
- Ensure compliance with internal SOPs and external regulatory standards.
Basic Qualifications / Required Skills
- MD or DO.
- Endocrinologist or internal medicine physician with cardiometabolic late-stage development experience, including type 2 diabetes.
- 8+ years clinical research and development experience; deep knowledge of global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated clinical/medical, administrative, and project management skills; strong verbal/written communication; experience managing/training large clinical teams.
Preferred
- Experience designing and launching large teams.
Travel/Work & Benefits
- Up to 30% travel; hybrid (on-site ~2.5 days/week).
- Relocation support available.
- Base salary range (US): $274,500–$457,500; bonus target 25% of base; eligible for long-term incentive. Comprehensive benefits including 401(k) with matching, paid leave, and medical/dental/vision.
Application instructions
- None provided in the text.