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

Responsibilities:

• Lead clinical development for assigned Internal Medicine asset(s) as single clinical point of accountability, driving design, execution, and interpretation of studies for worldwide regulatory submissions.
• Create and gain endorsement for the Clinical Development Plan and associated protocol design documents.
• Lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations).
• Negotiate clinical program tradeoffs and milestones with Medicine Team Lead to deliver on agreed timelines and budget.
• Develop global clinical development plan (including China/Japan) and pediatric investigation/study plan with optimized operational execution.
• Provide product/program input to target product profile(s); bring innovative, bold decision-making.
• Develop clinical development enabling strategies (digital/innovation and patient engagement).
• Partner with trial clinicians on governance reviews and provide category clinical development strategy insights.
• Provide therapy area/indication expertise for clinical data review (CRF design, signal interpretation, adverse event contextualization).
• Support trial-level statistical analysis plans, TLFs, and database release with Statistics/Programming.
• Develop and own submission deliverables (IAP, IARP, submission TLFs), including SCE and SCS; review/approve submission safety narrative plan.
• Support product label development and maintenance; interpret/communicate clinical trial data.
• Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/patient advocates) to inform clinical strategy and PDD development.
• Provide regulatory submission support (DSUR, PBRER) and product defense; ensure compliance with internal SOPs and external regulations.

• PhD or Pharm
  
  D.
• 8+ years clinical R&D experience (academia and/or biopharma) with Phase 1–3 clinical development and translational medicine.
• Background in chronic weight management, endocrinology, or internal medicine.
• Extensive knowledge of global/regional regulation, ICH/GCP, adverse event management.
• Demonstrated clinical/medical, administrative, and project management, verbal/written communication.
• Experience managing and training large clinical development teams (experience designing/launching large teams preferred).

• Leadership and ability to influence cross-functional matrix teams.
• Ability to manage and motivate internal clinical trial teams.
• Conflict management, accountability, team building, and effective execution amid change.

• Comprehensive benefits including 401(k) with Pfizer matching, paid vacation/holidays/personal days, caregiver/parental and medical leave, and medical/prescription/dental/vision coverage.