Executive Medical Director, Clinical Development, Obesity

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The Executive Medical Director, Clinical Sciences, Obesity is responsible for effectively executing large and/or complex studies and/or programs and serves as an expert resource to anticipate/resolve study/asset clinical and conduct issues. For assigned programs, the incumbent will serve as the Clinical Program Lead (CPL) for one or more compounds in multiple indicationsdriving broader cross functional perspective in the creation of clinical program development strategies. This role reports into the Internal Medicine Obesity CPL,Clinical Sciences and is also leader of select Global Clinical Sub-Teams for the design, implementation, execution and submission/approval of a clinical development program to support decision milestones and regulatory requirements.This role is a clinical subject matter expert for the CDU for assigned program(s) / asset(s). A typical day in the life of an Executive Medical Director may include the following: 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 I – III 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. This job may be for you if you have the following: MD or MD/PhD required; >8 years of involvement in clinical research or drug development in an industry environment spanning clinical activities in Phases I through IV. Academic experience may be considered. ≥6 years people management experience required, 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) #MDJOBSCD, #MDJOBS, #GDTherapeuticJobs
Location:
Tarrytown

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