Global Development Lead, Internal Medicine (MD, Sr. Director)
Pfizer
August 11, 2026
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Responsibilities
- Lead cross-functional clinical development for assigned Internal Medicine assets; ensure study design, execution, and interpretation for worldwide regulatory submissions.
- Create and gain endorsement for the Clinical Development Plan and protocol design documents; partner through study lifecycle (including with external partners when applicable).
- Oversee comprehensive global clinical development planning to secure approval and reimbursement; develop pediatric investigation/study plans and protocol designs.
- Provide product/program input to target product profiles; drive innovative/bold decision-making and clinical development enabling strategies (digital/innovation/patient engagement).
- Support governance reviews with trial clinicians; provide therapy-area expertise for clinical data review (CRF design, signal interpretation, AE contextualization).
- Contribute to trial-level statistical analysis plans and data deliverables (TLFs, database release); develop submission deliverables (IAP/IARP, submission TLFs), including SCE/SCS, and support safety narrative approval.
- Support product label development/maintenance; engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/advocates).
- Provide regulatory submission support and disclosures (DSUR, PBRER), product defense, and ensure compliance with SOPs and regulatory standards; review IIR proposals.
Basic Qualifications
- MD or DO
- Preferred: Cardiologist with cardiovascular outcome trials or large complex global development programs.
- 8+ years clinical R&D experience with success in academia and/or biopharma.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management.
- Demonstrated clinical/medical, project/administrative management, communication skills; experience leading/training large teams.
Travel/Work Environment
- Up to 30% travel; hybrid (on-site ~2.5 days/week).
Relocation support available.
- Lead cross-functional clinical development for assigned Internal Medicine assets; ensure study design, execution, and interpretation for worldwide regulatory submissions.
- Create and gain endorsement for the Clinical Development Plan and protocol design documents; partner through study lifecycle (including with external partners when applicable).
- Oversee comprehensive global clinical development planning to secure approval and reimbursement; develop pediatric investigation/study plans and protocol designs.
- Provide product/program input to target product profiles; drive innovative/bold decision-making and clinical development enabling strategies (digital/innovation/patient engagement).
- Support governance reviews with trial clinicians; provide therapy-area expertise for clinical data review (CRF design, signal interpretation, AE contextualization).
- Contribute to trial-level statistical analysis plans and data deliverables (TLFs, database release); develop submission deliverables (IAP/IARP, submission TLFs), including SCE/SCS, and support safety narrative approval.
- Support product label development/maintenance; engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/advocates).
- Provide regulatory submission support and disclosures (DSUR, PBRER), product defense, and ensure compliance with SOPs and regulatory standards; review IIR proposals.
Basic Qualifications
- MD or DO
- Preferred: Cardiologist with cardiovascular outcome trials or large complex global development programs.
- 8+ years clinical R&D experience with success in academia and/or biopharma.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management.
- Demonstrated clinical/medical, project/administrative management, communication skills; experience leading/training large teams.
Travel/Work Environment
- Up to 30% travel; hybrid (on-site ~2.5 days/week).
Relocation support available.