Global Development Lead, Internal Medicine (MD, Sr. Director)
Pfizer
August 11, 2026
Remote friendly (Bothell, WA)
United States
Clinical Research and Development
Responsibilities:
- Lead clinical development for assigned assets; represent Clinical on the Global Medicine Team as the single clinical point of accountability.
- Lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) for design, execution, and interpretation of studies supporting global regulatory submissions.
- Create and gain endorsement for the Clinical Development Plan and associated protocol design documents.
- Provide global program input for pediatric investigation plan/study plan and optimized operational execution.
- Develop clinical development enabling strategies (including digital/innovation and patient engagement).
- Partner with trial clinicians on governance reviews and provide therapy-area expertise (CRF design, signal interpretation, AE contextualization).
- Contribute to trial-level statistical analysis plan, TLFs, database release; develop submission deliverables (IAP/IARP, submission TLFs) including SCE/SCS; review/approve submission safety narrative plan.
- Support label development/maintenance and interpret/communicate clinical data.
- Provide regulatory submission support (DSUR, PBRER) and product defense; ensure compliance with SOPs and external regulatory standards.
Qualifications:
- MD or DO.
- 8+ years of relevant experience in clinical research and development (academia and/or biopharma).
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated clinical/medical, project/admin management, and strong verbal/written communication.
- Demonstrated experience managing/training large clinical development teams; experience designing/launching large teams preferred.
- Strong preference for cardiologist with cardiovascular outcome trials or large complex global development programs.
Required/Preferred skills/competencies:
- Medical/scientific credibility; ability to coordinate clinical development/lifecycle strategy.
- Leadership and influence in complex matrix environments; conflict management, accountability, and team-building.
- Lead clinical development for assigned assets; represent Clinical on the Global Medicine Team as the single clinical point of accountability.
- Lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) for design, execution, and interpretation of studies supporting global regulatory submissions.
- Create and gain endorsement for the Clinical Development Plan and associated protocol design documents.
- Provide global program input for pediatric investigation plan/study plan and optimized operational execution.
- Develop clinical development enabling strategies (including digital/innovation and patient engagement).
- Partner with trial clinicians on governance reviews and provide therapy-area expertise (CRF design, signal interpretation, AE contextualization).
- Contribute to trial-level statistical analysis plan, TLFs, database release; develop submission deliverables (IAP/IARP, submission TLFs) including SCE/SCS; review/approve submission safety narrative plan.
- Support label development/maintenance and interpret/communicate clinical data.
- Provide regulatory submission support (DSUR, PBRER) and product defense; ensure compliance with SOPs and external regulatory standards.
Qualifications:
- MD or DO.
- 8+ years of relevant experience in clinical research and development (academia and/or biopharma).
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated clinical/medical, project/admin management, and strong verbal/written communication.
- Demonstrated experience managing/training large clinical development teams; experience designing/launching large teams preferred.
- Strong preference for cardiologist with cardiovascular outcome trials or large complex global development programs.
Required/Preferred skills/competencies:
- Medical/scientific credibility; ability to coordinate clinical development/lifecycle strategy.
- Leadership and influence in complex matrix environments; conflict management, accountability, and team-building.