Global Development Lead, Internal Medicine, Sr. Director (MD)
Pfizer
August 10, 2026
Remote friendly (Pearl River, NY)
United States
Clinical Research and Development
Responsibilities:
- Lead cross-functional Clinical Development Team for assigned Internal Medicine asset(s) through study design, execution, and interpretation for worldwide regulatory submissions.
- Own and gain endorsement for the Clinical Development Plan and associated protocol design documents.
- Create pediatric investigation/study plan and protocol design documents to ensure trial feasibility and optimized execution.
- Negotiate tradeoffs, milestones, and ensure delivery of clinical program within agreed timelines and budget.
- Provide product/program input for target product profile(s).
- Drive innovative, bold clinical development decisions; develop clinical development enabling strategies (digital/innovation and patient engagement).
- Partner with trial clinicians on governance reviews (incl. Sci/Ops); provide category clinical development strategy input.
- Provide therapy area/indication expertise for clinical data review (CRF design, signal interpretation, adverse event contextualization).
- Provide specialized medical monitoring support if required.
- Contribute to trial-level statistical analysis plan, TLFs, table-listings-figures, and database release with statistics/programming.
- Develop submission-level deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve submission-level safety narrative plan.
- Support interpretation/communication of clinical trial data; support product label development and maintenance.
- Engage external stakeholders (Ad boards, Steering Committees, DMC, adjudication committees, patients/advocates) to support clinical development strategy and PDD development.
- Provide regulatory submission support (DSUR, PBRER) including product defense; ensure compliance with internal SOPs and external regulatory standards.
- Review IIR proposals.
Basic Qualifications:
- MD or DO.
- 8+ years of relevant experience in clinical research and development (academia and/or biopharma), with Phase 1–3 clinical development and translational medicine experience.
- Background in chronic weight management, endocrinology, or internal medicine.
- Extensive knowledge of global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated medical/clinical, administrative, and project management capabilities; effective verbal/written communication.
- Demonstrated experience managing/training large teams; designing/launching large teams preferred.
Additional Competencies/Skills:
- Ability to coordinate/execute clinical development or lifecycle strategy; influence cross-functional teams in a matrix.
- Leadership, influencing, conflict management, team building, accountability, and change agility.
Benefits:
- Participation in Pfizer Global Performance Plan (bonus target 25%) and eligibility for share-based long-term incentive.
- 401(k) with matching contributions and additional retirement savings contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/prescription/dental/vision coverage.
Work/Environment:
- Up to 30% travel; hybrid role (on-site ~2.5 days/week).
Application instructions:
- Not provided in the posting.
- Lead cross-functional Clinical Development Team for assigned Internal Medicine asset(s) through study design, execution, and interpretation for worldwide regulatory submissions.
- Own and gain endorsement for the Clinical Development Plan and associated protocol design documents.
- Create pediatric investigation/study plan and protocol design documents to ensure trial feasibility and optimized execution.
- Negotiate tradeoffs, milestones, and ensure delivery of clinical program within agreed timelines and budget.
- Provide product/program input for target product profile(s).
- Drive innovative, bold clinical development decisions; develop clinical development enabling strategies (digital/innovation and patient engagement).
- Partner with trial clinicians on governance reviews (incl. Sci/Ops); provide category clinical development strategy input.
- Provide therapy area/indication expertise for clinical data review (CRF design, signal interpretation, adverse event contextualization).
- Provide specialized medical monitoring support if required.
- Contribute to trial-level statistical analysis plan, TLFs, table-listings-figures, and database release with statistics/programming.
- Develop submission-level deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve submission-level safety narrative plan.
- Support interpretation/communication of clinical trial data; support product label development and maintenance.
- Engage external stakeholders (Ad boards, Steering Committees, DMC, adjudication committees, patients/advocates) to support clinical development strategy and PDD development.
- Provide regulatory submission support (DSUR, PBRER) including product defense; ensure compliance with internal SOPs and external regulatory standards.
- Review IIR proposals.
Basic Qualifications:
- MD or DO.
- 8+ years of relevant experience in clinical research and development (academia and/or biopharma), with Phase 1–3 clinical development and translational medicine experience.
- Background in chronic weight management, endocrinology, or internal medicine.
- Extensive knowledge of global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated medical/clinical, administrative, and project management capabilities; effective verbal/written communication.
- Demonstrated experience managing/training large teams; designing/launching large teams preferred.
Additional Competencies/Skills:
- Ability to coordinate/execute clinical development or lifecycle strategy; influence cross-functional teams in a matrix.
- Leadership, influencing, conflict management, team building, accountability, and change agility.
Benefits:
- Participation in Pfizer Global Performance Plan (bonus target 25%) and eligibility for share-based long-term incentive.
- 401(k) with matching contributions and additional retirement savings contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/prescription/dental/vision coverage.
Work/Environment:
- Up to 30% travel; hybrid role (on-site ~2.5 days/week).
Application instructions:
- Not provided in the posting.