Executive Medical Director, Clinical Development, Obesity

Role Summary

The Executive Medical Director, Clinical Sciences, Obesity is responsible for effectively managing obesity opportunities in an end-to-end framework (clinic entry through lifecycle management). This role involves engagement with Discovery, Medical Affairs, and other functional stakeholders to contribute to obesity strategy, clinical planning, target engagement, dose selection, proof-of-concept, pivotal study design, label negotiation, and lifecycle management. The Clinical Program Lead may manage multiple indications and drive cross-functional clinical program development strategies. This role reports to the Internal Medicine CVRM VP Therapeutic Area Lead and leads select Global Clinical Sub-Teams for design, implementation, execution and submission/approval of clinical development programs to meet decision milestones and regulatory requirements. It is a clinical subject matter expert role for the Clinical Development Unit for assigned program(s)/asset(s).

Responsibilities

• Leads the Global Clinical Subteam (GCST) and clinical development representative at the Strategic Program Team (SPT) for assigned assets, managing all clinical aspects and driving execution of assigned clinical program(s).
• Leads the development and execution of the Clinical Development Plan (CDP) including Phase 1‚Äì3 trials designed for successful global registration of the compound.
• Leads creation of clinical components of key documents (regulatory documents, registration dossiers, etc.) supporting registration, market access, and commercialization of the compound(s).
• Acts as medical expert and leader in interactions with external and internal stakeholders.
• Ensures safety of the drug, including the safety aspects of patients in clinical studies and signal detection from post-marketing surveillance, with support from Global Patient Safety.
• Ensures quality of all clinical documents produced by GCST (e.g., Investigators‚Äô Brochure, protocol, study report, clinical components of regulatory submissions, safety-related documents).
• Builds and leads effective teams; manages activities of teams up to Senior Medical Director level; establishes objectives and work plans, delegating assignments to staff.
• Partners with operations to ensure high-quality execution of the clinical development portfolio.
• Partners and helps lead BD processes.

Qualifications

• MD or MD/PhD required with specialized residency and fellowship training; >8 years of involvement in clinical research or drug development in industry, spanning Phases 1‚Äì4.
• ‚â•6 years of people management experience desirable, including matrix environments.
• Strong management, interpersonal, communication, negotiation, and problem-solving skills.
• Significant cross-functional experience and organizational awareness.
• Medical/scientific expertise in Endocrinology, CV/Metabolism, and/or Obesity strongly preferred.
• Understanding of global regulatory environment and approval processes.
• Strong understanding of operational aspects of all phases of clinical trial conduct (start-up, conduct, close-out).

Skills

• Leadership and team-building
• Strategic program development
• Regulatory and submissions expertise
• Clinical trial design and execution
• Stakeholder management and negotiation
• Risk management and safety signal detection

Education

• MD or MD/PhD with relevant residency/fellowship; advanced training in endocrinology, metabolism, or obesity preferred

Additional Requirements

• On-site requirement: 4 days per week in Tarrytown, NY; Warren, NJ; or Cambridge, MA.