Global Development Lead, Internal Medicine, Sr. Director (MD)
Pfizer
August 07, 2026
Remote friendly (Bothell, WA)
United States
Clinical Research and Development
Responsibilities:
- Lead clinical development for assigned Internal Medicine/R&D asset(s) as the single clinical point of accountability.
- Design, execute, and interpret studies supporting worldwide regulatory submissions; lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations).
- Create and gain endorsement for the Clinical Development Plan and associated protocol design documents.
- Partner with Medicine Team Lead to negotiate tradeoffs, milestones, and deliver the clinical program within timelines and budget.
- Secure global approval and reimbursement (including China and Japan); create pediatric investigation/study plan and protocol design documents.
- Provide input for target product profile(s); drive innovative/bold decisions across programs.
- Develop clinical development enabling strategies (digital/innovation and patient engagement).
- Conduct governance reviews with trial clinicians; provide therapy area/indication expertise (CRF design, signal interpretation, contextualizing adverse events).
- Provide specialized monitoring and trial-level statistical analysis plan support; contribute to TLFs, database release deliverables.
- Develop submission deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve safety narrative plan.
- Support product label development/maintenance and regulatory submission support (DSUR, PBRER) including product defense.
- Ensure compliance with internal SOPs and external regulatory standards; review IIR proposals.
- Engage external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients).
Qualifications:
- MD or DO.
- Background in chronic weight management, endocrinology, or internal medicine; experience in Phase 1–3 clinical development and translational medicine.
- 8+ years relevant clinical R&D experience in academia and/or biopharma.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated clinical/medical, administrative, and project management skills; effective verbal and written communication.
- Demonstrated experience managing/training large teams (designing/launching large teams preferred).
Skills/Behaviors:
- Matrix management and influence across cross-functional teams; leadership and team building.
- Strong conflict management, accountability, and ability to perform amid uncertainty.
Additional:
- Up to 30% travel; hybrid work (on-site ~2.5 days/week).
- Lead clinical development for assigned Internal Medicine/R&D asset(s) as the single clinical point of accountability.
- Design, execute, and interpret studies supporting worldwide regulatory submissions; lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations).
- Create and gain endorsement for the Clinical Development Plan and associated protocol design documents.
- Partner with Medicine Team Lead to negotiate tradeoffs, milestones, and deliver the clinical program within timelines and budget.
- Secure global approval and reimbursement (including China and Japan); create pediatric investigation/study plan and protocol design documents.
- Provide input for target product profile(s); drive innovative/bold decisions across programs.
- Develop clinical development enabling strategies (digital/innovation and patient engagement).
- Conduct governance reviews with trial clinicians; provide therapy area/indication expertise (CRF design, signal interpretation, contextualizing adverse events).
- Provide specialized monitoring and trial-level statistical analysis plan support; contribute to TLFs, database release deliverables.
- Develop submission deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve safety narrative plan.
- Support product label development/maintenance and regulatory submission support (DSUR, PBRER) including product defense.
- Ensure compliance with internal SOPs and external regulatory standards; review IIR proposals.
- Engage external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients).
Qualifications:
- MD or DO.
- Background in chronic weight management, endocrinology, or internal medicine; experience in Phase 1–3 clinical development and translational medicine.
- 8+ years relevant clinical R&D experience in academia and/or biopharma.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated clinical/medical, administrative, and project management skills; effective verbal and written communication.
- Demonstrated experience managing/training large teams (designing/launching large teams preferred).
Skills/Behaviors:
- Matrix management and influence across cross-functional teams; leadership and team building.
- Strong conflict management, accountability, and ability to perform amid uncertainty.
Additional:
- Up to 30% travel; hybrid work (on-site ~2.5 days/week).