Global Development Lead, Internal Medicine, Sr. Director; MD

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.

• 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.

• 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.

• 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.

• Up to 30% travel; hybrid role (on-site ~2.5 days/week).