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

Responsibilities

• Lead clinical development accountability for assigned Internal Medicine asset(s); represent Clinical on Global Medicine Team.
• Build and gain endorsement for Clinical Development Plan and associated protocol design documents.
• Lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) for study design, execution, and interpretation supporting global regulatory submissions.
• Develop pediatric investigation/study plan and protocol design; ensure feasibility and optimized execution.
• Provide therapy area/indication expertise for clinical data review (CRF design, signal interpretation, adverse event contextualization).
• Contribute to target product profile(s) and regulatory activities (labels, core data sheets, Investigator Brochures, DSUR, PBRER).
• Partner on trial-level statistical analysis plan, TLFs/table-listings-figures, and database release.
• Develop submission deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve safety narrative plan.
• Support label development/maintenance; engage external stakeholders (e.g., ad boards, Steering Committees, DMC, adjudication, patients/advocates).
• Ensure compliance with internal SOPs and external regulatory standards.
• May assume additional Obesity portfolio clinical leadership; may provide specialized medical monitoring if required.

• PhD or Pharm
  
  D.
• 8+ years clinical R&D experience;
  Ph1–3 clinical development and translational medicine.
• Background in chronic weight management/endocrinology/internal medicine.
• Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management.
• Demonstrated clinical/medical, administrative, and project management; strong written/verbal communication.

• Demonstrated experience managing/training large teams; designing and launching large teams.

• Clinical/scientific credibility; ability to coordinate clinical lifecycle strategy.
• Leadership and influence in a complex matrix; conflict management; accountability; ability to deliver amid change.

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

• Participation in Global Performance Plan (bonus target 22.5%) and eligibility for share-based long-term incentives; comprehensive benefits including 401(k) match, paid time off, caregiver/parental leave, and medical/dental/vision.