Global Development Lead, Internal Medicine (Sr. Director)
Pfizer
August 13, 2026
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Role Summary
- The Global Development Lead (GDL) is the single clinical point of accountability for clinical development for assigned Internal Medicine asset(s).
- Leads the cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) to design, execute, and interpret studies supporting worldwide regulatory submissions.
- Accountable for creating and securing endorsement of the Clinical Development Plan and associated protocol design documents.
- May assume additional clinical leadership for Obesity portfolio late-stage assets (trial design, execution, reporting).
Responsibilities
- Partner with the Prod Team Lead to negotiate tradeoffs, milestones, and ensure clinical program delivery within timelines and budget.
- Develop comprehensive clinical development plan to secure global approval and reimbursement (including China and Japan), including pediatric investigation/study plan and protocol design.
- Provide input for target product profiles; deliver clinical development enabling strategies (digital/innovation and patient engagement).
- Partner with trial clinicians on governance reviews; provide therapy area/indication expertise (CRF design, signal interpretation, adverse event contextualization).
- Support statistical analysis plan, TLFs/table-listings-figures, and database release.
- Develop submission-level deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve safety narrative plan.
- Support product label development/maintenance; engage external stakeholders (Ad boards, steering committees, DMC, adjudication committees, patients).
- Provide regulatory submission support (DSUR, PBRER), product defense, and ensure compliance with SOPs and regulatory standards.
Basic Qualifications
- BS with 12 years or PhD with 7 years relevant clinical/industry experience.
Experience/Required Skills
- Experience leading cardiometabolic late-stage development (including type 2 diabetes).
- Track record of success in academia and/or biopharma clinical R&D.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated clinical/medical, administrative, and project management skills; strong verbal and written communication.
- Demonstrated ability to manage and train large clinical development teams (and design/launch large teams preferred).
Competencies
- Scientific credibility/excellence; leadership and influencing in matrix environments; conflict management and team building; accountability; ability to operate amid uncertainty and organizational change.
Non-standard Work/Environment
- Up to 30% travel; hybrid role working on-site ~2.5 days/week.
Relocation
- Relocation support available.
- The Global Development Lead (GDL) is the single clinical point of accountability for clinical development for assigned Internal Medicine asset(s).
- Leads the cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) to design, execute, and interpret studies supporting worldwide regulatory submissions.
- Accountable for creating and securing endorsement of the Clinical Development Plan and associated protocol design documents.
- May assume additional clinical leadership for Obesity portfolio late-stage assets (trial design, execution, reporting).
Responsibilities
- Partner with the Prod Team Lead to negotiate tradeoffs, milestones, and ensure clinical program delivery within timelines and budget.
- Develop comprehensive clinical development plan to secure global approval and reimbursement (including China and Japan), including pediatric investigation/study plan and protocol design.
- Provide input for target product profiles; deliver clinical development enabling strategies (digital/innovation and patient engagement).
- Partner with trial clinicians on governance reviews; provide therapy area/indication expertise (CRF design, signal interpretation, adverse event contextualization).
- Support statistical analysis plan, TLFs/table-listings-figures, and database release.
- Develop submission-level deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve safety narrative plan.
- Support product label development/maintenance; engage external stakeholders (Ad boards, steering committees, DMC, adjudication committees, patients).
- Provide regulatory submission support (DSUR, PBRER), product defense, and ensure compliance with SOPs and regulatory standards.
Basic Qualifications
- BS with 12 years or PhD with 7 years relevant clinical/industry experience.
Experience/Required Skills
- Experience leading cardiometabolic late-stage development (including type 2 diabetes).
- Track record of success in academia and/or biopharma clinical R&D.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated clinical/medical, administrative, and project management skills; strong verbal and written communication.
- Demonstrated ability to manage and train large clinical development teams (and design/launch large teams preferred).
Competencies
- Scientific credibility/excellence; leadership and influencing in matrix environments; conflict management and team building; accountability; ability to operate amid uncertainty and organizational change.
Non-standard Work/Environment
- Up to 30% travel; hybrid role working on-site ~2.5 days/week.
Relocation
- Relocation support available.