Global Development Lead, Internal Medicine, Sr. Director (non-MD)
Pfizer
August 10, 2026
Remote friendly (Pennsylvania, United States)
United States
Clinical Research and Development
Role Summary
The Global Development Lead (GDL) represents Clinical on the Global Medicine Team and is the single clinical point of accountability for clinical development for assigned asset(s) in Internal Medicine, Research & Development, Pfizer. Leads cross-functional clinical development teams to design, execute, and interpret studies for worldwide regulatory submissions.
Responsibilities
- Create and secure endorsement for the Clinical Development Plan and associated protocol design documents.
- Lead cross-functional delivery of the clinical program within agreed timelines and budget.
- Develop global clinical development plans (including China and Japan) and pediatric investigation/study plans with protocol design documents.
- Provide product/program input for target product profiles.
- Deliver innovative clinical development decisions; develop enabling strategies (digital/innovation and patient engagement).
- Partner with trial clinicians on governance reviews (Sci/Ops) and provide category strategy input.
- Provide therapy area/indication expertise for clinical data review (CRF design, signal interpretation, adverse event contextualization).
- Provide specialized medical monitoring support as needed.
- Partner on trial-level statistical analysis plans, TLFs, and database release.
- Develop submission deliverables (IAP, IARP, submission TLFs) and submission components (SCE, SCS); support safety narrative plan review/approval.
- Support product label development/maintenance and interpret/communicate trial data.
- Engage external stakeholders (Ad boards, Steering Committees, DMC, Adjudication Committees, patients/patient advocates) to support clinical development strategy and PDD.
- Support regulatory submissions/disclosures (DSUR, PBRER) and product defense; ensure compliance with SOPs and regulatory standards.
Basic Qualifications
- PhD or PharmD.
- 8+ years of relevant experience in clinical research/development (academia and/or biopharma); Phase 1–3 clinical development and translational medicine experience.
- Background in chronic weight management, endocrinology, or internal medicine.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
Additional Requirements/Skills (Competency)
- Demonstrated clinical/medical, administrative, and project management; strong verbal/written communication.
- Demonstrated experience managing/training large teams (and preferred experience designing/launching large teams).
- Ability to influence in a matrixed environment; leadership, conflict management, team building, accountability, and change agility.
Travel/Work Location
- Up to 30% travel.
- Hybrid: commute distance; work on-site ~2.5 days/week.
Compensation/Benefits
- Eligible for Global Performance Plan bonus (22.5% target) and long-term incentive; comprehensive benefits including 401(k) match, retirement contribution, paid leave, and medical/dental/vision.
Application Instructions
- Not specified in provided text.
The Global Development Lead (GDL) represents Clinical on the Global Medicine Team and is the single clinical point of accountability for clinical development for assigned asset(s) in Internal Medicine, Research & Development, Pfizer. Leads cross-functional clinical development teams to design, execute, and interpret studies for worldwide regulatory submissions.
Responsibilities
- Create and secure endorsement for the Clinical Development Plan and associated protocol design documents.
- Lead cross-functional delivery of the clinical program within agreed timelines and budget.
- Develop global clinical development plans (including China and Japan) and pediatric investigation/study plans with protocol design documents.
- Provide product/program input for target product profiles.
- Deliver innovative clinical development decisions; develop enabling strategies (digital/innovation and patient engagement).
- Partner with trial clinicians on governance reviews (Sci/Ops) and provide category strategy input.
- Provide therapy area/indication expertise for clinical data review (CRF design, signal interpretation, adverse event contextualization).
- Provide specialized medical monitoring support as needed.
- Partner on trial-level statistical analysis plans, TLFs, and database release.
- Develop submission deliverables (IAP, IARP, submission TLFs) and submission components (SCE, SCS); support safety narrative plan review/approval.
- Support product label development/maintenance and interpret/communicate trial data.
- Engage external stakeholders (Ad boards, Steering Committees, DMC, Adjudication Committees, patients/patient advocates) to support clinical development strategy and PDD.
- Support regulatory submissions/disclosures (DSUR, PBRER) and product defense; ensure compliance with SOPs and regulatory standards.
Basic Qualifications
- PhD or PharmD.
- 8+ years of relevant experience in clinical research/development (academia and/or biopharma); Phase 1–3 clinical development and translational medicine experience.
- Background in chronic weight management, endocrinology, or internal medicine.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
Additional Requirements/Skills (Competency)
- Demonstrated clinical/medical, administrative, and project management; strong verbal/written communication.
- Demonstrated experience managing/training large teams (and preferred experience designing/launching large teams).
- Ability to influence in a matrixed environment; leadership, conflict management, team building, accountability, and change agility.
Travel/Work Location
- Up to 30% travel.
- Hybrid: commute distance; work on-site ~2.5 days/week.
Compensation/Benefits
- Eligible for Global Performance Plan bonus (22.5% target) and long-term incentive; comprehensive benefits including 401(k) match, retirement contribution, paid leave, and medical/dental/vision.
Application Instructions
- Not specified in provided text.