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Job

Vice President Clinical Development

  • Location

    Southern California

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Karina Nurmberg

  • Contact email:

    k.nurmberg@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    2 months ago

  • Expiry date:

    2022-05-11

Job Summary

The Medical Director is responsible for the development of clinical research strategies and direction of Phase 1-3 clinical studies while working with cross-functional teams. S/he will be responsible for study design, development, data readout, and summary. This position will also provide ongoing input into assessment and interpretation of safety data and contribute to investigator training.

Job Details

  • In-depth understanding of the scientific method and clinical applications based on medical, scientific, and practical rationale.
  • Provide clinical/scientific input to study design, protocol concepts/protocols preparation, statistical analysis plans, and reporting within assigned programs to yield high value clinical endpoint insight for future critical decisions.
  • Must possess sound scientific and clinical judgement with ability to properly interpret clinical trial data.
  • Familiarity with concepts of clinical research and clinical trial design, including biostatistics.
  • Support the development of key scientific relationships with external opinion leaders and make scientific presentations at advisory boards, key scientific meetings and external committee meetings.
  • May serve as Medical Monitor responsible for the safety monitoring of clinical trials, and as the medical expert for clinical studies.
  • Participate in preparation of abstracts, manuscripts, and presentations for external meetings as well as author clinical sections of regulatory documents (IB, IND sections).
  • Conduct medical assessment and disposition of adverse events (in conjunction with Drug Safety Physician) and evaluate safety of clinical compounds prior to and during ongoing clinical studies.
  • Provide periodic status updates and effectively communicate with Senior Management Team.
  • Support the development of regulatory documents for filings and agency meetings and participate in interactions with regulatory agencies.

Education

  • MD degree
  • Accredited residency training and board certification in relevant clinical specialty.

Candidate Qualifications

  • 2 to 10 years’ experience in pharmaceutical and/or biotechnology industry developing investigational new drugs or experience in a clinical research organization involved in clinical trials.
  • Experience with drug development in metabolic diseases (preferred).
  • Ability to work with a high level of autonomy/independence.
  • Review and interprets scientific knowledge of competitor landscape (molecule / indication).
  • Knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities; experience with FDA and other health authorities strongly desired. Skills and Attributes

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