Global Development Lead, Internal Medicine, Sr. Director (MD)
Pfizer
9 hours ago
Remote friendly (Bothell, WA)
United States
Clinical Research and Development
Responsibilities
- Serve as the single clinical point of accountability for clinical development of assigned Internal Medicine asset(s); lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) to design, execute, and interpret studies for global regulatory submissions.
- Create and gain endorsement for the Clinical Development Plan and protocol design documents; partner across the lifecycle for feasibility and optimized operations.
- Oversee pediatric investigation plan/study plan and protocol design with trial clinicians.
- Provide therapy area expertise for clinical data review (CRF design, signal interpretation, adverse event contextualization).
- Contribute to target product profiles and regulatory deliverables (labels, core data sheets, Investigator Brochures, DSUR, PBRER, Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports; SCE/SCS).
- Support statistical analysis/data deliverables (analysis plan, TLFs, table-listings-figures, database release) and develop submission safety narratives.
- Engage external stakeholders (ad boards, Steering Committees, DMC, adjudication committees, patients/patient advocates).
- Ensure compliance with internal SOPs and external regulatory standards; review IIR proposals.
Basic Qualifications
- MD or DO.
- 8+ years relevant experience; Phase 1–3 clinical development and translational medicine.
- Background in chronic weight management, endocrinology, or internal medicine.
- Extensive knowledge of global/regional regulation, ICH/GCP, and adverse event management.
Preferred/Skills/Competencies
- Leadership/influence in matrixed environments; manage/train large teams.
- Proven project, administrative, and communication skills.
Work requirements
- Up to 30% travel; hybrid role (average ~2.5 days/week onsite).
Compensation/Benefits (if part of posting)
- Base salary: $274,500–$457,500; bonus target 25% plus long-term incentives; comprehensive benefits (401(k), paid leave, medical/dental/vision).
- Serve as the single clinical point of accountability for clinical development of assigned Internal Medicine asset(s); lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) to design, execute, and interpret studies for global regulatory submissions.
- Create and gain endorsement for the Clinical Development Plan and protocol design documents; partner across the lifecycle for feasibility and optimized operations.
- Oversee pediatric investigation plan/study plan and protocol design with trial clinicians.
- Provide therapy area expertise for clinical data review (CRF design, signal interpretation, adverse event contextualization).
- Contribute to target product profiles and regulatory deliverables (labels, core data sheets, Investigator Brochures, DSUR, PBRER, Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports; SCE/SCS).
- Support statistical analysis/data deliverables (analysis plan, TLFs, table-listings-figures, database release) and develop submission safety narratives.
- Engage external stakeholders (ad boards, Steering Committees, DMC, adjudication committees, patients/patient advocates).
- Ensure compliance with internal SOPs and external regulatory standards; review IIR proposals.
Basic Qualifications
- MD or DO.
- 8+ years relevant experience; Phase 1–3 clinical development and translational medicine.
- Background in chronic weight management, endocrinology, or internal medicine.
- Extensive knowledge of global/regional regulation, ICH/GCP, and adverse event management.
Preferred/Skills/Competencies
- Leadership/influence in matrixed environments; manage/train large teams.
- Proven project, administrative, and communication skills.
Work requirements
- Up to 30% travel; hybrid role (average ~2.5 days/week onsite).
Compensation/Benefits (if part of posting)
- Base salary: $274,500–$457,500; bonus target 25% plus long-term incentives; comprehensive benefits (401(k), paid leave, medical/dental/vision).