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

Responsibilities

• Lead cross-functional Clinical Development Team to design, execute, and interpret studies for worldwide regulatory submissions.
• Create and gain endorsement of the Clinical Development Plan and associated protocol design documents.
• Lead pediatric investigation plan/study plan and protocol design; ensure trial feasibility and optimized operations.
• Provide product/program input to Target Product Profile(s); develop clinical development enabling strategies (digital/innovation, patient engagement).
• Partner with trial clinicians on governance reviews; provide therapy area/indication expertise (CRF design, signal interpretation, adverse event context).
• Contribute to 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.
• Support regulatory submissions/disclosures (DSUR, PBRER) and product defense.
• Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/advocates).
• Ensure compliance with internal SOPs and external regulatory standards.

Qualifications (Basic)

• PhD/PharmD.
• 8+ years clinical research & development; Phase 1–3 and translational medicine experience.
• Background in chronic weight management, endocrinology, or internal medicine.
• Extensive knowledge of clinical development, ICH/GCP, global/regional regulation, adverse event management.

Skills/Competencies

• Clinical/pharmaceutical development excellence; strong leadership/influencing in matrixed teams; conflict management; accountability; change agility.

Compensation/Benefits (if hired)

• Base salary: $214,900–$358,100; bonus target 22.5%; eligible for share-based long-term incentives; 401(k) with matching; paid vacation/holidays/personal days; caregiver/parental and medical leave; medical/dental/vision.

Work/Travel

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