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Job

Senior Medical Director

  • Location

    REMOTE

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Karina Nurmberg

  • Contact email:

    k.nurmberg@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    4 months ago

  • Expiry date:

    2022-03-26

  • Startdate:

    ASAP

Position Summary

The Senior Medical Director drives the design, safety monitoring, and data analysis of the Company’s late-phase clinical trials in endocrinology.  As such, the Senior Medical Director is an important leader within the clinical development team.  The Senior Medical Director will report to the Vice President, Clinical Development.

Key Responsibilities 

  • As the therapeutic area clinical lead, contributes to the formulation and implementation of the Clinical Development Plan
  • May be asked to represent clinical development on the endocrinology Project Core Team
  • Leverage medical expertise and hands-on clinical experience to promote relevance and rigor of the development program
  • For clinical trials: design, provide overall oversight, and support site and subject retention
  • Serve as a medical monitor for clinical trials, ensure study integrity, and track accumulating safety and efficacy data
  • Provide leadership to teams of medical monitors: oversee all aspects of the clinical monitoring process in accordance with ICH GCPs and global SOPs to assess the safety and efficacy of investigational products
  • Provide leadership to study teams
  • Ensure successful completion of trial-related documents (including clinical trial protocols, investigator brochures, medical monitoring plans, site training materials, clinical study reports, health authority responses, standard operating procedures, etc.) with cross-functional team members
  • Anticipate and solve complex drug development problems
  • Contribute to regulatory strategy
  • Contribute to drafting and reviewing of clinical documents, manuscripts, presentations, and regulatory submissions
  • Maintain up-to-date knowledge of relevant science, medical information, good clinical practices, and regulatory guidance
  • Collaborate with—and serve as a clinical research resource for—cross-functional colleagues (e.g. in clinical operations, statistics, regulatory affairs, medical affairs, health economics outcomes research, commercial, finance) to optimize product development
  • Represent the clinical development department incorporate strategic and organizational initiatives
  • Travel up to 20% domestically and internationally for scientific meetings

Knowledge and Experience 

  • M.D. degree
  • Physician licensure in at least one state (strongly preferred)
  • Board-certified (strongly preferred), with specialty in endocrinology highly desired
  • At least 10 years of industry experience (other relevant experience e.g. post-graduate experience in the clinical and/or academic realms may also be considered on a case-by-case basis).  Those with less experience may be considered for a Medical Director position.
  • At least 8 years of experience with clinical trial design and execution

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