Vice President, Clinical Pharmacology

Our client is a biotechnology company developing treatments to target cancer. They have asked us to assist them in their search for a Vice President, Clinical Pharmacology

Major tasks and responsibilities include:
  • Oversees the design and implementation of clinical pharmacology plans using traditional and model informed drug development approaches.
  • Manages the clinical pharmacology study process from protocol development to final study reporting.
  • Evaluates and performs hands-on analysis of clinical PK/PD data as well as authorizes PK clinical study reports.
  • Contributes to clinical pharmacology strategy and planning for clinical programs.
  • Ensures timely and accurate communication of study results and interpretation to appropriate internal drug development teams.
  • Provides PK/PD modeling to support dosing strategies for clinical programs.
  • Writes and edits dose rationale sections of clinical protocols and investigator brochures, INDs, CTAs and NDAs.
  • Prepares the clinical pharmacology components of regulatory submissions and represents the clinical pharmacology line at meetings with regulatory agencies and health authorities.
  • Maintains a current understanding of PK and PD literature and methodology, as well as the scientific literature related to the specific drug discovery projects.
  • Ensures appropriate quality of documentation for internal department studies compatible with global regulatory submission requirements.
We seek candidates with the following qualifications:
  • A PhD, MD, or PharmD with relevant expertise in pharmacokinetics, pharmacology or pharmaceutical science is required.
  • Must have fifteen years of direct industry experience in conducting clinical stage drug development.
  • Must be experienced in developing clinical pharmacology plans and in the preparation of regulatory submissions (including INDs, NDAs, BLAs and/or significant sNDAs/sBLAs).
  • Requires experience in responding to regulatory questions related to all aspects of clinical pharmacology.
  • Must hold knowledge and experience in the application of current practices in the areas of clinical pharmacology, pharmacokinetics, oncology, drug metabolism, bioanalysis, biopharmaceutics, regulatory affairs, and toxicology.
  • Population PK/PD analysis and PBPK modeling experience is a plus.

If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms and Forbes' list of Top 200 Best Executive Recruiting Firms.
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