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Job

VP/Head of Clinical Operations

  • Location

    New York City

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Marin Haugo

  • Contact email:

    m.haugo@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Job ref:

    REF-5

  • Published:

    2 months ago

  • Expiry date:

    2022-08-03

  • Startdate:

    ASAP

Our client is a publically traded, small clinical-stage, biopharma company actively hiring for a VP/Head of Clinical Operations. The client is looking for an exceptional individual with extensive Clinical Operations experience, who can come in and hit the ground running as part of an innovative team, developing breakthrough therapies to help cancer patients, in their NYC-based office.  This role is highly visible and hybrid (3 days per week in the office). 

Qualifications:

  • In-depth understanding and working knowledge of FDA regulations and drug development processes
  • Understanding of BLA documents
  • Experience managing CRO to produce documents, listings, and fill in clinical operational gaps
  • Demonstrated excellence in project/program management
  • Ability to work on problems and comfortable with ambiguity
  • Proven ability to lead in a manner that creates a motivated, committed, and engaged clinical development operations teams, internal and external teams
  • Experience in clinical development of biologics
  • Demonstrated experience in successfully leading teams in an effective, efficient manner
  • Direct experience in preparation of regulatory submissions, presentation to regulatory advisory panels in support of registration of a new drug
  • Radiopharmaceutical experience is preferred  

Education

  • BA, MS, PhD, or equivalent experience