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.

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