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

Responsibilities

• Lead cross-functional Clinical Development Team for assigned Internal Medicine/obesity asset(s) in design, execution, and interpretation of studies supporting global regulatory submissions.
• Build and gain endorsement for the Clinical Development Plan and associated protocol design documents.
• Negotiate tradeoffs/milestones and ensure delivery of the clinical program on agreed timelines and budget.
• Create global clinical development plan for approval and reimbursement (incl. China/Japan), including pediatric investigation/study plan and protocol documents.
• Provide product/program input for target product profiles; apply innovative, bold decision-making.
• Develop clinical development enabling strategies (digital/innovation and patient engagement).
• Partner on governance reviews and provide therapy area expertise (CRF design, signal interpretation, adverse event contextualization).
• Support trial-level statistical analysis (SAP, TLFs, database release), submission deliverables (IAP/IARP, submission TLFs), and safety narrative plan; support label development/maintenance.
• Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/advocates) to inform clinical development and PDD.
• Support regulatory submissions/disclosure deliverables (e.g., DSUR, PBRER) and ensure compliance with internal SOPs/external standards.

Basic Qualifications

• PhD or PharmD.
• 8+ years clinical R&D experience; Phase 1–3 clinical development and translational medicine.
• Background in chronic weight management, endocrinology, or internal medicine.
• Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
• Demonstrated leadership managing/training large teams; strong verbal/written communication and project/admin management.

Work/Environment

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