Global Development Lead, Internal Medicine (MD, Sr. Director)
Pfizer
August 11, 2026
Remote friendly (Tampa, FL)
United States
Clinical Research and Development
Responsibilities
- Lead cross-functional Clinical Development Team to design, execute, and interpret studies supporting worldwide regulatory submissions for assigned asset(s).
- Create and gain endorsement for the Clinical Development Plan and associated protocol design documents; ensure global feasibility and optimized operational execution (incl. pediatric investigation/study plans).
- Negotiate clinical program tradeoffs, milestones, and ensure delivery within timelines and budget.
- Provide therapy area/indication expertise (e.g., CRF design, signal interpretation, adverse event contextualization).
- Develop clinical development enabling strategies (digital/innovation and patient engagement).
- Partner on governance reviews; provide category clinical development strategy input.
- Support trial-level statistical analysis plan, TLFs/table-listings-figures, and database release.
- Develop submission-level deliverables (IAP, IARP, submission TLFs; SCE, SCS) and submission safety narrative plan; support label development/maintenance.
- Support regulatory submission deliverables and product defense (DSUR, PBRER); ensure compliance with SOPs and regulatory standards.
- Engage external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients/advocates).
Basic Qualifications
- MD or DO.
- 8+ years clinical research/development experience (academia and/or biopharma).
- Cardiologist strongly preferred; cardiovascular outcome trials or large complex global programs.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management.
Required/Preferred Skills
- Strong clinical/medical and project management; excellent verbal/written communication.
- Demonstrated experience managing/training large clinical development teams; designing/launching large teams preferred.
Competency Requirements (selected)
- Influence in matrix environment; leadership; accountability; conflict management; change agility; team building.
Work/Travel
- Up to 30% travel; hybrid (on-site ~2.5 days/week).
- Lead cross-functional Clinical Development Team to design, execute, and interpret studies supporting worldwide regulatory submissions for assigned asset(s).
- Create and gain endorsement for the Clinical Development Plan and associated protocol design documents; ensure global feasibility and optimized operational execution (incl. pediatric investigation/study plans).
- Negotiate clinical program tradeoffs, milestones, and ensure delivery within timelines and budget.
- Provide therapy area/indication expertise (e.g., CRF design, signal interpretation, adverse event contextualization).
- Develop clinical development enabling strategies (digital/innovation and patient engagement).
- Partner on governance reviews; provide category clinical development strategy input.
- Support trial-level statistical analysis plan, TLFs/table-listings-figures, and database release.
- Develop submission-level deliverables (IAP, IARP, submission TLFs; SCE, SCS) and submission safety narrative plan; support label development/maintenance.
- Support regulatory submission deliverables and product defense (DSUR, PBRER); ensure compliance with SOPs and regulatory standards.
- Engage external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients/advocates).
Basic Qualifications
- MD or DO.
- 8+ years clinical research/development experience (academia and/or biopharma).
- Cardiologist strongly preferred; cardiovascular outcome trials or large complex global programs.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management.
Required/Preferred Skills
- Strong clinical/medical and project management; excellent verbal/written communication.
- Demonstrated experience managing/training large clinical development teams; designing/launching large teams preferred.
Competency Requirements (selected)
- Influence in matrix environment; leadership; accountability; conflict management; change agility; team building.
Work/Travel
- Up to 30% travel; hybrid (on-site ~2.5 days/week).