Executive Medical Director, Clinical Development CV/Renal/Metabolism

Role Summary

Executive Medical Director, Clinical Development CV/Renal/Metabolism leads end-to-end obesity development opportunities, coordinating across Discovery, Medical Affairs and other functional areas to shape target selection, clinical planning, dose selection, and lifecycle management. The role oversees global clinical development plans (Phase 1–3), regulatory submissions, and lifecycle strategy, and leads select Global Clinical Sub-Teams to support decision milestones and regulatory requirements. Reports to the Internal Medicine CVRM VP Therapeutic Area Lead and partners with cross-functional stakeholders to drive program success.

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 development and execution of the Clinical Development Plan (CDP) including Phase 1 – 3 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 the support from Global Patient Safety.
• Ensures quality of all clinical documents (e.g., Investigators’ Brochure, protocol, study report, clinical components of regulatory submissions, safety related documents) produced by GCST.
• Builds and leads effective teams. Manages and oversees activities of teams up to Senior Medical Director level; Establishes operational objectives and work plans, delegating assignments to subordinate staff.
• Partner with operations team 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 an industry environment spanning clinical activities in Phases 1 through 4.
• ≥6 years people management experience desirable, this may include management in a matrix environment.
• Strong management, interpersonal, communication, negotiation and problem-solving skills.
• Considerable organization awareness (e.g., inter-relationship of departments, business priorities), including significant experience working cross-functionally.
• Medical/scientific expertise in Endocrinology, CV/Metabolism, and/or Obesity is strongly preferred.
• Understanding of global regulatory environment including key regulatory agencies and approval processes.
• Strong understanding of operational aspects of all phases of clinical trial conduct (start-up, conduct, close-out).

Additional Requirements

• On-site requirement: four days per week on-site in Tarrytown, NY.