Global Development Lead, Internal Medicine (MD, Sr. Director)
Pfizer
September 01, 2026
Remote friendly (New York, NY)
United States
Clinical Research and Development
Role Summary
The Global Development Lead (GDL) is the clinical point of accountability for clinical development for assigned Internal Medicine asset(s) within Pfizer. Leads cross-functional Clinical Development Teams to design, execute, and interpret studies supporting worldwide regulatory submissions. Accountable for creating and gaining endorsement for the Clinical Development Plan and associated protocol design documents.
Responsibilities
- Partner with the Medicine Team Lead to negotiate tradeoffs, milestones, and ensure delivery within timelines and budget.
- Own comprehensive clinical development planning globally (including China and Japan), including pediatric investigation/study plan and protocol design documents.
- Provide product/program input for target product profiles (TPPs).
- Drive innovative, bold decision-making across studies and develop clinical development enabling strategies (digital/innovation, patient engagement).
- Partner with trial clinicians on governance reviews (incl. Sci/Ops); provide therapy-area strategy, CRF design input, and support signal interpretation and AE contextualization.
- Provide specialized medical monitoring support if required.
- Contribute to trial-level statistical analysis plans, TLFs, and database release (with statistics/programming).
- Develop submission deliverables (IAP, IARP, submission TLFs) including SCE and SCS; support interpretation and communication of clinical data; review/approve submission safety narrative plan.
- Support product label development/maintenance.
- Engage external stakeholders (Ad boards, Steering Committees, DMC, adjudication committees, patients/advocates) to inform clinical development strategy and PDD.
- Provide regulatory submission support (DSUR, PBRER) and product defense; ensure SOP/regulatory compliance; review IIR proposals.
Basic Qualifications
- Education: MD or DO.
- Experience: Cardiologist (strongly preferred) with cardiovascular outcome trials or large complex global development programs; 8+ years relevant clinical research/development experience; deep knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management; demonstrated clinical/administrative/project management and communication; experience managing/training large clinical teams.
Competency Requirements
- Medical/scientific credibility; management in complex matrix environments; leadership and influencing skills; conflict management; team building; accountability; agility in uncertainty.
Non-standard Work Schedule/Location
- Up to 30% travel; hybrid (live within commuting distance; ~2.5 days/week on-site).
Benefits (explicitly stated)
- Eligible for Pfizer Global Performance Plan bonus target (25% of base salary) and share-based long-term incentive program; 401(k) with matching and additional retirement contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/prescription/dental/vision.
Application Instructions
- Authorized to be employed in the U.S.; U.S. work visa sponsorship not available.
The Global Development Lead (GDL) is the clinical point of accountability for clinical development for assigned Internal Medicine asset(s) within Pfizer. Leads cross-functional Clinical Development Teams to design, execute, and interpret studies supporting worldwide regulatory submissions. Accountable for creating and gaining endorsement for the Clinical Development Plan and associated protocol design documents.
Responsibilities
- Partner with the Medicine Team Lead to negotiate tradeoffs, milestones, and ensure delivery within timelines and budget.
- Own comprehensive clinical development planning globally (including China and Japan), including pediatric investigation/study plan and protocol design documents.
- Provide product/program input for target product profiles (TPPs).
- Drive innovative, bold decision-making across studies and develop clinical development enabling strategies (digital/innovation, patient engagement).
- Partner with trial clinicians on governance reviews (incl. Sci/Ops); provide therapy-area strategy, CRF design input, and support signal interpretation and AE contextualization.
- Provide specialized medical monitoring support if required.
- Contribute to trial-level statistical analysis plans, TLFs, and database release (with statistics/programming).
- Develop submission deliverables (IAP, IARP, submission TLFs) including SCE and SCS; support interpretation and communication of clinical data; review/approve submission safety narrative plan.
- Support product label development/maintenance.
- Engage external stakeholders (Ad boards, Steering Committees, DMC, adjudication committees, patients/advocates) to inform clinical development strategy and PDD.
- Provide regulatory submission support (DSUR, PBRER) and product defense; ensure SOP/regulatory compliance; review IIR proposals.
Basic Qualifications
- Education: MD or DO.
- Experience: Cardiologist (strongly preferred) with cardiovascular outcome trials or large complex global development programs; 8+ years relevant clinical research/development experience; deep knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management; demonstrated clinical/administrative/project management and communication; experience managing/training large clinical teams.
Competency Requirements
- Medical/scientific credibility; management in complex matrix environments; leadership and influencing skills; conflict management; team building; accountability; agility in uncertainty.
Non-standard Work Schedule/Location
- Up to 30% travel; hybrid (live within commuting distance; ~2.5 days/week on-site).
Benefits (explicitly stated)
- Eligible for Pfizer Global Performance Plan bonus target (25% of base salary) and share-based long-term incentive program; 401(k) with matching and additional retirement contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/prescription/dental/vision.
Application Instructions
- Authorized to be employed in the U.S.; U.S. work visa sponsorship not available.