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

Responsibilities

• Serve as single clinical point of accountability for clinical development of assigned internal medicine assets; lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) to design, execute, and interpret studies for worldwide regulatory submissions.
• Create and gain endorsement for the Clinical Development Plan and associated protocol design documents; ensure trial feasibility and optimized operational execution.
• Lead pediatric investigation plan/study plan and protocol design; develop submission deliverables (IAP, IARP, submission TLFs) including SCE and SCS.
• Provide therapy area/indication expertise (CRF design, signal interpretation, adverse event contextualization); partner on trial-level statistical analysis plan, TLFs/table-listings-figures, and database release.
• Support regulatory submissions and disclosures/defense (e.g., DSUR, PBRER), safety narrative plan review/approval, and product label development/maintenance.
• Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/patient advocates) to drive clinical development strategy.

• MD or DO.
• 8+ years relevant experience in clinical research/development (academia and/or biopharma);
  Phase 1–3 clinical development and translational medicine experience.
• Background in chronic weight management, endocrinology, or internal medicine; extensive knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management.
• Demonstrated clinical/medical, project/administrative management, and effective verbal/written communication skills; experience managing/training large teams.

• Base salary $274,500–$457,500
• bonus target 25%
• participation in share-based long-term incentive
• comprehensive health/401(k) and other leave/vacation benefits.