Global Development Lead, Internal Medicine (MD, Sr. Director)
Pfizer
September 02, 2026
Remote friendly (La Jolla, CA)
United States
Clinical Research and Development
Role Summary
- Global Development Lead (GDL) for assigned Internal Medicine asset(s). Single clinical point of accountability for clinical development. Leads cross-functional Clinical Development Team to design, execute, and interpret studies supporting worldwide regulatory submissions.
- Accountable for creating and gaining endorsement for Clinical Development Plan and associated protocol design documents. Acts as partner across study lifecycle and may support external partners under Partner of Choice.
Responsibilities
- Partner with Medicine Team Lead to negotiate tradeoffs/milestones and deliver clinical program within timelines and budget.
- Lead global clinical development planning to secure approval and reimbursement; create pediatric investigation/study plan and protocol design documents.
- Provide input for target product profiles and regulatory activities (e.g., product labels, Investigator Brochures, DSURs, PBRERs, Development Safety Update Reports, PBRE evaluations).
- Lead governance and therapy-area clinical strategy (CRF design, signal interpretation, adverse event contextualization).
- Contribute to statistical analysis plan, TLFs (tables/listings/figures), database release; develop submission deliverables (IAP/IARP, IAP/TLFs, SCE/SCS, safety narrative plan).
- Support label development/maintenance; interpret/communicate clinical trial data.
- Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/advocates) to support clinical development strategy.
- Ensure compliance with internal SOPs and external regulatory standards; review/approve safety and IIR proposals.
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 (cardiovascular outcome trials or large complex global programs).
Competency Requirements (high level)
- Medical/scientific excellence; management in complex matrix; leadership/influencing; conflict management; team building; accountability; agility in change.
Work/Logistics
- Up to 30% travel; hybrid role (live within commuting distance; ~2.5 days/week on-site); relocation support available.
- Application instructions not provided in the excerpt.
- Global Development Lead (GDL) for assigned Internal Medicine asset(s). Single clinical point of accountability for clinical development. Leads cross-functional Clinical Development Team to design, execute, and interpret studies supporting worldwide regulatory submissions.
- Accountable for creating and gaining endorsement for Clinical Development Plan and associated protocol design documents. Acts as partner across study lifecycle and may support external partners under Partner of Choice.
Responsibilities
- Partner with Medicine Team Lead to negotiate tradeoffs/milestones and deliver clinical program within timelines and budget.
- Lead global clinical development planning to secure approval and reimbursement; create pediatric investigation/study plan and protocol design documents.
- Provide input for target product profiles and regulatory activities (e.g., product labels, Investigator Brochures, DSURs, PBRERs, Development Safety Update Reports, PBRE evaluations).
- Lead governance and therapy-area clinical strategy (CRF design, signal interpretation, adverse event contextualization).
- Contribute to statistical analysis plan, TLFs (tables/listings/figures), database release; develop submission deliverables (IAP/IARP, IAP/TLFs, SCE/SCS, safety narrative plan).
- Support label development/maintenance; interpret/communicate clinical trial data.
- Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/advocates) to support clinical development strategy.
- Ensure compliance with internal SOPs and external regulatory standards; review/approve safety and IIR proposals.
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 (cardiovascular outcome trials or large complex global programs).
Competency Requirements (high level)
- Medical/scientific excellence; management in complex matrix; leadership/influencing; conflict management; team building; accountability; agility in change.
Work/Logistics
- Up to 30% travel; hybrid role (live within commuting distance; ~2.5 days/week on-site); relocation support available.
- Application instructions not provided in the excerpt.