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Job

Executive 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:

    2022-04-02

  • Startdate:

    ASAP

Position Summary

The Senior/Executive Director Clinical Development will provide leadership for one or more drug development programs. The successful candidate will provide medical and scientific expertise on the strategy, design, execution, and interpretation of data from late-stage clinical solid tumor programs.

Key Responsibilities

  • Provide medical leadership for one or more oncology assets
  • Lead study team meetings and provide medical guidance to the clinical operations team in the execution of clinical trials
  • Evaluate scientific information and new ideas to assist in identifying new research opportunities
  • Secure, analyze and report on competitive intelligence related to successful conduct/execution of studies
  • Responsible for medical monitoring of one or more clinical trials
  • Represent clinical development to KOLs, investigators, regulatory agencies and present findings internally and externally (eg, investigator meetings, regulatory agency meetings)
  • Successfully interface with development partners
  • Contribute to determining global strategy for development of oncology assets
  • Author/review, in collaboration with other functions, protocols, ICFs, CRFs, CSRs, IBs, DSURs, PSURs, regulatory packages, NDAs, MAAs
  • Review and interpret clinical trial data and prepare manuscripts, abstracts, and presentations for scientific meetings

Candidate Requirements

  • MD (or equivalent) required
  • Training in oncology required; US fellowship and board-certification preferred
  • 5+ years’ experience in oncology clinical development, with experience in small and large pharma
  • Direct experience in authoring NDA/MAA
  • Global clinical trial experience, including Phases 1 through 3 studies
  • Extensive knowledge of oncology clinical drug development, including FDA regulations, statistics, safety, etc
  • Experience in working with small molecule targeted agents

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