Global Development Lead, Internal Medicine (MD, Sr. Director)
Pfizer
August 11, 2026
Remote friendly (Lake Forest, IL)
United States
Clinical Research and Development
Responsibilities:
- Lead cross-functional clinical development for assigned Internal Medicine asset(s), including design, execution, and interpretation of studies supporting 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 timelines and budget.
- Secure global approval and reimbursement; create pediatric investigation plan/study plan and protocol design documents with trial clinicians to ensure feasibility and optimized execution.
- Provide product/program input to target product profile(s); drive innovative, bold clinical development decisions.
- Develop clinical development enabling strategies (digital/innovation and patient engagement).
- Conduct governance reviews (incl. Sci/Ops) with trial clinicians and provide category clinical development strategy input.
- Provide therapy area/indication expertise (CRF design, signal interpretation, adverse event contextualization) and specialized medical monitoring if required.
- Partner on trial-level statistical analysis plan, TLFs/table-listings-figures, and database release.
- Develop submission-level deliverables (IAP, IARP, submission TLFs); lead submission deliverables including SCE and SCS; support clinical data interpretation and communication.
- Review/approve submission-level safety narrative plan; support product label development and maintenance.
- Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/advocates) to inform strategy and PDD development.
- Provide regulatory submission support (DSUR, PBRER) and product defense; ensure compliance with internal SOPs and external regulations; review IIR proposals.
Basic Qualifications:
- MD or DO.
- 8+ years relevant experience in clinical research and development (academia and/or biopharma).
- Strong preference: Cardiologist with cardiovascular outcome trials or large complex global development programs.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
Preferred/Competency Requirements:
- Demonstrated medical/scientific excellence, leadership, influencing, conflict management, and team building in matrixed environments.
- Demonstrated experience managing and training large clinical development teams; designing and launching large teams preferred.
Education/Travel/Environment:
- Up to 30% travel; hybrid role (live within commuting distance; ~2.5 days/week on-site).
Relocation:
- Relocation support available.
Application:
- Not specified in the provided text.
- Lead cross-functional clinical development for assigned Internal Medicine asset(s), including design, execution, and interpretation of studies supporting 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 timelines and budget.
- Secure global approval and reimbursement; create pediatric investigation plan/study plan and protocol design documents with trial clinicians to ensure feasibility and optimized execution.
- Provide product/program input to target product profile(s); drive innovative, bold clinical development decisions.
- Develop clinical development enabling strategies (digital/innovation and patient engagement).
- Conduct governance reviews (incl. Sci/Ops) with trial clinicians and provide category clinical development strategy input.
- Provide therapy area/indication expertise (CRF design, signal interpretation, adverse event contextualization) and specialized medical monitoring if required.
- Partner on trial-level statistical analysis plan, TLFs/table-listings-figures, and database release.
- Develop submission-level deliverables (IAP, IARP, submission TLFs); lead submission deliverables including SCE and SCS; support clinical data interpretation and communication.
- Review/approve submission-level safety narrative plan; support product label development and maintenance.
- Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/advocates) to inform strategy and PDD development.
- Provide regulatory submission support (DSUR, PBRER) and product defense; ensure compliance with internal SOPs and external regulations; review IIR proposals.
Basic Qualifications:
- MD or DO.
- 8+ years relevant experience in clinical research and development (academia and/or biopharma).
- Strong preference: Cardiologist with cardiovascular outcome trials or large complex global development programs.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
Preferred/Competency Requirements:
- Demonstrated medical/scientific excellence, leadership, influencing, conflict management, and team building in matrixed environments.
- Demonstrated experience managing and training large clinical development teams; designing and launching large teams preferred.
Education/Travel/Environment:
- Up to 30% travel; hybrid role (live within commuting distance; ~2.5 days/week on-site).
Relocation:
- Relocation support available.
Application:
- Not specified in the provided text.