Global Development Lead, Internal Medicine (MD, Sr. Director)
Pfizer
August 11, 2026
Remote friendly (Pennsylvania, United States)
United States
Clinical Research and Development
Responsibilities
- Lead cross-functional Clinical Development Team design, execution, and interpretation of studies for worldwide regulatory submissions.
- 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 agreed timelines and budget.
- Lead global clinical development plan to secure approval and reimbursement (including China and Japan), including pediatric investigation/study plan and protocol documents.
- Provide product/program input for target product profiles; bring innovative, bold decision-making.
- Develop clinical development enabling strategies (digital/innovation and patient engagement).
- Conduct governance reviews with trial clinicians (incl. Sci/Ops) and provide category strategy input.
- Provide therapy area/indication expertise for clinical data review (CRF design, signal interpretation, AE contextualization).
- Support trial-level statistical analysis plan, TLFs, table-listings-figures, and database release with statistics/programming.
- Develop submission-level deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve safety narrative plan.
- Support product label development/maintenance; provide DSUR/PBRER support and product defense.
- Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/advocates) to support development strategy and PDD.
- Ensure compliance with internal SOPs and external regulatory standards; review IIR proposals.
Qualifications/Skills
- MD or DO.
- Cardiologist (strongly preferred) with cardiovascular outcome trials or large complex global development programs.
- 8+ years clinical R&D experience with track record in academia and/or biopharma.
- Deep knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated clinical/medical, administrative, and project management; strong written/verbal communication.
- Experience managing/training large clinical development teams; experience designing and launching large teams preferred.
Competencies
- Scientific credibility; ability to coordinate and execute clinical lifecycle strategy.
- Influence and lead in a complex matrix; persuasive leadership.
- Conflict management, team building, accountability, and adaptability.
Other
- Up to 30% travel; relocation support available.
- Hybrid: live within commuting distance and work on-site ~2.5 days/week.
- Lead cross-functional Clinical Development Team design, execution, and interpretation of studies for worldwide regulatory submissions.
- 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 agreed timelines and budget.
- Lead global clinical development plan to secure approval and reimbursement (including China and Japan), including pediatric investigation/study plan and protocol documents.
- Provide product/program input for target product profiles; bring innovative, bold decision-making.
- Develop clinical development enabling strategies (digital/innovation and patient engagement).
- Conduct governance reviews with trial clinicians (incl. Sci/Ops) and provide category strategy input.
- Provide therapy area/indication expertise for clinical data review (CRF design, signal interpretation, AE contextualization).
- Support trial-level statistical analysis plan, TLFs, table-listings-figures, and database release with statistics/programming.
- Develop submission-level deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve safety narrative plan.
- Support product label development/maintenance; provide DSUR/PBRER support and product defense.
- Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/advocates) to support development strategy and PDD.
- Ensure compliance with internal SOPs and external regulatory standards; review IIR proposals.
Qualifications/Skills
- MD or DO.
- Cardiologist (strongly preferred) with cardiovascular outcome trials or large complex global development programs.
- 8+ years clinical R&D experience with track record in academia and/or biopharma.
- Deep knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated clinical/medical, administrative, and project management; strong written/verbal communication.
- Experience managing/training large clinical development teams; experience designing and launching large teams preferred.
Competencies
- Scientific credibility; ability to coordinate and execute clinical lifecycle strategy.
- Influence and lead in a complex matrix; persuasive leadership.
- Conflict management, team building, accountability, and adaptability.
Other
- Up to 30% travel; relocation support available.
- Hybrid: live within commuting distance and work on-site ~2.5 days/week.