Global Development Lead, Internal Medicine (MD, Sr. Director)
Pfizer
August 31, 2026
Remote friendly (Bothell, WA)
United States
Clinical Research and Development
Role Summary
The Global Development Lead (GDL) represents Clinical on the Global Medicine Team and is the clinical point of accountability for clinical development for assigned asset(s) in Internal Medicine.
Responsibilities
- Lead cross-functional Clinical Development Team (Clinical, Clinical Pharmacology, Statistics, Safety, Commercial, Patient Access, Operations) in designing, executing, and interpreting studies for worldwide regulatory submissions.
- Create and gain endorsement for the Clinical Development Plan and associated protocol design documents.
- Ensure delivery of the clinical program aligned to timelines and budget through partnership with the Medicine Team Lead.
- Develop global clinical development plan for approval/reimbursement; create pediatric investigation/study plans and protocol design documents.
- Provide input to target product profile(s) and regulatory activities (labels, core data sheets, Investigator Brochures, DSUR, PBRER, Periodic Benefit-Risk Evaluation Reports).
- Support trial governance and category clinical development strategy; provide therapy area/indication expertise (CRF design, signal interpretation, adverse event contextualization).
- Provide specialized medical monitoring support (if required).
- Partner on trial-level statistical analysis plan, TLFs, and database release.
- Develop submission deliverables (IAP, IARP, submission TLFs; SCE, SCS) and review/approve submission-level safety narrative plan.
- Support product label development/maintenance.
- Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/advocates) to inform clinical strategy and PDD development.
- Ensure compliance with internal SOPs and external regulatory standards; review IIR proposals.
Basic Qualifications
- MD or DO.
Experience/Skills (Required/Preferred)
- Cardiologist (strongly preferred) with cardiovascular outcome trials or large complex, global development programs.
- 8+ years in clinical research and development (academia and/or biopharma).
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated project management, communication, and experience managing/training large clinical teams; designing/launching large teams preferred.
Travel/Work Environment
- Up to 30% travel; hybrid role requiring commuting distance and ~2.5 days/week on-site.
The Global Development Lead (GDL) represents Clinical on the Global Medicine Team and is the clinical point of accountability for clinical development for assigned asset(s) in Internal Medicine.
Responsibilities
- Lead cross-functional Clinical Development Team (Clinical, Clinical Pharmacology, Statistics, Safety, Commercial, Patient Access, Operations) in designing, executing, and interpreting studies for worldwide regulatory submissions.
- Create and gain endorsement for the Clinical Development Plan and associated protocol design documents.
- Ensure delivery of the clinical program aligned to timelines and budget through partnership with the Medicine Team Lead.
- Develop global clinical development plan for approval/reimbursement; create pediatric investigation/study plans and protocol design documents.
- Provide input to target product profile(s) and regulatory activities (labels, core data sheets, Investigator Brochures, DSUR, PBRER, Periodic Benefit-Risk Evaluation Reports).
- Support trial governance and category clinical development strategy; provide therapy area/indication expertise (CRF design, signal interpretation, adverse event contextualization).
- Provide specialized medical monitoring support (if required).
- Partner on trial-level statistical analysis plan, TLFs, and database release.
- Develop submission deliverables (IAP, IARP, submission TLFs; SCE, SCS) and review/approve submission-level safety narrative plan.
- Support product label development/maintenance.
- Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/advocates) to inform clinical strategy and PDD development.
- Ensure compliance with internal SOPs and external regulatory standards; review IIR proposals.
Basic Qualifications
- MD or DO.
Experience/Skills (Required/Preferred)
- Cardiologist (strongly preferred) with cardiovascular outcome trials or large complex, global development programs.
- 8+ years in clinical research and development (academia and/or biopharma).
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated project management, communication, and experience managing/training large clinical teams; designing/launching large teams preferred.
Travel/Work Environment
- Up to 30% travel; hybrid role requiring commuting distance and ~2.5 days/week on-site.