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.

Qualifications / Required

• PhD or PharmD.


• 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.

Preferred / Additional

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

Skills / Competencies

• Clinical/scientific credibility; ability to coordinate clinical lifecycle strategy.


• Leadership and influence in a complex matrix; conflict management; accountability; ability to deliver amid change.

Work requirements

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

Benefits (explicitly stated)

• 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.