Responsibilities:
- Lead cross-functional Clinical Development Team for assigned Internal Medicine asset(s), including design, execution, and interpretation of studies supporting global regulatory submissions.
- Create and gain endorsement for Clinical Development Plan and protocol design documents; ensure trial feasibility and optimized execution across the study lifecycle.
- Negotiate clinical program tradeoffs, milestones, timelines, and budget with Medicine Team Lead.
- Provide therapy-area/indication expertise for clinical data review (CRF design, signal interpretation, adverse event contextualization).
- Develop clinical development enabling strategies (digital/innovation and patient engagement).
- Partner on governance reviews (including Sci/Ops) and provide category clinical development strategy input.
- Contribute to statistical analysis planning and submission TLFs/database release (with statistics/programming).
- Lead regulatory submission workstream and contribute to deliverables (e.g., SCE, SCS, clinical overview; DSUR, PBRER; safety narrative review; product defense).
- Support product label development/maintenance; provide input to target product profiles.
- Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/patient advocates).
- May provide specialized medical monitoring; may review IIR proposals. May lead obesity portfolio leadership (trial design/execution/reporting for late-stage assets).
Qualifications/Required:
- PhD or PharmD.
- 8+ years clinical R&D experience; Phase 1β3 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.
Preferred/Skills:
- Proven clinical/medical, project/administrative management, and strong written/verbal communication.
- Demonstrated leadership managing/training large teams; influence in a matrix.
Benefits/Compensation (if applicable): Base salary $214,900β$358,100; bonus target 22.5%; participation in share-based incentives; 401(k) with match, paid leave, and medical/dental/vision.
Work requirements:
- Up to 30% travel; hybrid (on-site ~2.5 days/week).