Global Development Lead, Internal Medicine (Sr. Director)
Pfizer
August 13, 2026
Remote friendly (New York, NY)
United States
Clinical Research and Development
Responsibilities:
- Lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) for assigned Internal Medicine asset(s), including study design, execution, and interpretation for worldwide regulatory submissions.
- Create and gain endorsement for Clinical Development Plan and associated protocol design documents; partner with trial clinicians across study lifecycle.
- Lead pediatric investigation/study plan and protocol design documents; ensure trial feasibility and optimized operational execution.
- Provide product/program input for target product profile(s).
- Drive innovative/bold decision-making and develop clinical development enabling strategies (digital/innovation, patient engagement).
- Provide therapy area/indication expertise for clinical data review (CRF design, signal interpretation, adverse event contextualization).
- Support trial-level statistical analysis plan and trial outputs (TLFs, tables/listings/figures, database release).
- Develop submission-level deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve submission-level safety narrative plan; support label development/maintenance.
- Support regulatory submissions and disclosure deliverables (DSUR, PBRER) and product defense; ensure compliance with SOPs and regulatory standards.
- Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/patient advocates).
Basic Qualifications:
- BS with 12 years or PhD with 7 years relevant clinical/industry experience.
Experience/Skills:
- Leading cardiometabolic late-stage development (incl. type 2 diabetes); track record in academia and/or biopharma clinical R&D.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management.
- Demonstrated leadership, matrix management, team management/training, and strong written/verbal communication.
Benefits (if applicable):
- Eligibility for Global Performance Plan bonus (target 22.5% of base) and share-based long-term incentive; comprehensive health and retirement benefits; paid time off and caregiver/parental and medical leave; relocation support available.
Work Requirements:
- Up to 30% travel; hybrid—on-site ~2.5 days/week.
- Lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) for assigned Internal Medicine asset(s), including study design, execution, and interpretation for worldwide regulatory submissions.
- Create and gain endorsement for Clinical Development Plan and associated protocol design documents; partner with trial clinicians across study lifecycle.
- Lead pediatric investigation/study plan and protocol design documents; ensure trial feasibility and optimized operational execution.
- Provide product/program input for target product profile(s).
- Drive innovative/bold decision-making and develop clinical development enabling strategies (digital/innovation, patient engagement).
- Provide therapy area/indication expertise for clinical data review (CRF design, signal interpretation, adverse event contextualization).
- Support trial-level statistical analysis plan and trial outputs (TLFs, tables/listings/figures, database release).
- Develop submission-level deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve submission-level safety narrative plan; support label development/maintenance.
- Support regulatory submissions and disclosure deliverables (DSUR, PBRER) and product defense; ensure compliance with SOPs and regulatory standards.
- Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/patient advocates).
Basic Qualifications:
- BS with 12 years or PhD with 7 years relevant clinical/industry experience.
Experience/Skills:
- Leading cardiometabolic late-stage development (incl. type 2 diabetes); track record in academia and/or biopharma clinical R&D.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management.
- Demonstrated leadership, matrix management, team management/training, and strong written/verbal communication.
Benefits (if applicable):
- Eligibility for Global Performance Plan bonus (target 22.5% of base) and share-based long-term incentive; comprehensive health and retirement benefits; paid time off and caregiver/parental and medical leave; relocation support available.
Work Requirements:
- Up to 30% travel; hybrid—on-site ~2.5 days/week.