Global Development Lead, Internal Medicine (MD, Sr. Director)
Pfizer
September 02, 2026
Remote friendly (Tampa, FL)
United States
Clinical Research and Development
Responsibilities
- Serve as Clinical single point of accountability for clinical development of assigned Internal Medicine assets; lead cross-functional Clinical Development Team.
- Create and gain endorsement for Clinical Development Plan and protocol design documents; partner across study lifecycle.
- Lead global (incl. China/Japan) clinical development planning to support regulatory submissions, approvals, and reimbursement; develop pediatric investigation plan/study plan.
- Provide therapy area expertise for clinical data review (CRF design, signal interpretation, AE contextualization) and support clinical monitoring if required.
- Contribute to trial-level statistical analysis plan, TLFs, table-listings-figures, and database release (with statistics/programming).
- Develop submission deliverables (IAP/IARP, submission TLFs), including SCE and SCS; review/approve safety narrative plan.
- Support label development/maintenance; support regulatory disclosure deliverables and product defense (DSUR, PBRER).
- Ensure compliance with internal SOPs and external regulatory standards; engage external stakeholders to drive clinical strategy.
Basic Qualifications
- MD or DO.
- 8+ years clinical R&D experience; extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Cardiologist strongly preferred with cardiovascular outcome trials or large complex global programs.
- Demonstrated clinical/medical, project, and administrative leadership; experience managing and training large teams (launching large teams preferred).
Competencies (selected)
- Cross-functional leadership/influence in a matrix environment; accountability, conflict management, team building, and effective communication.
Non-standard / Location
- Up to 30% travel; hybrid role (on-site ~2.5 days/week). Relocation support available.
Benefits (explicit)
- Eligible for bonus (25% target), long-term incentive; 401(k) with matching, paid leave/days, and medical/dental/vision coverage.
- Serve as Clinical single point of accountability for clinical development of assigned Internal Medicine assets; lead cross-functional Clinical Development Team.
- Create and gain endorsement for Clinical Development Plan and protocol design documents; partner across study lifecycle.
- Lead global (incl. China/Japan) clinical development planning to support regulatory submissions, approvals, and reimbursement; develop pediatric investigation plan/study plan.
- Provide therapy area expertise for clinical data review (CRF design, signal interpretation, AE contextualization) and support clinical monitoring if required.
- Contribute to trial-level statistical analysis plan, TLFs, table-listings-figures, and database release (with statistics/programming).
- Develop submission deliverables (IAP/IARP, submission TLFs), including SCE and SCS; review/approve safety narrative plan.
- Support label development/maintenance; support regulatory disclosure deliverables and product defense (DSUR, PBRER).
- Ensure compliance with internal SOPs and external regulatory standards; engage external stakeholders to drive clinical strategy.
Basic Qualifications
- MD or DO.
- 8+ years clinical R&D experience; extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Cardiologist strongly preferred with cardiovascular outcome trials or large complex global programs.
- Demonstrated clinical/medical, project, and administrative leadership; experience managing and training large teams (launching large teams preferred).
Competencies (selected)
- Cross-functional leadership/influence in a matrix environment; accountability, conflict management, team building, and effective communication.
Non-standard / Location
- Up to 30% travel; hybrid role (on-site ~2.5 days/week). Relocation support available.
Benefits (explicit)
- Eligible for bonus (25% target), long-term incentive; 401(k) with matching, paid leave/days, and medical/dental/vision coverage.