Senior Director Clinical Pharmacology Job at Meet Life Sciences, San Jose, CA

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  • Meet Life Sciences
  • San Jose, CA

Job Description

Meet has been awarded an exclusive search with a clinical-stage biopharmaceutical company that is pioneering a novel approach to treating cancer. With a robust pipeline of solid and liquid tumor targets their lead program has shown promising results in early clinical trials and was recently awarded fast-track and orphan drug designation.

As a result our Client is going through a period of growth and seeking a Sr. Director, Clinical Pharmacology. As an early member of the Clin Pharm function you will have an opportunity to influence the direction of the CP group, whilst leading a team.

Responsibilities:

  • Develop clinical pharmacology development plans
  • Oversee and contribute to clinical pharmacology sections of protocols, PK/PD reports, CDP and regulatory documents
  • Ensure modeling and simulation methods inform internal and external decisions
  • Integrate PK/PD and safety data to optimize dosing for patient populations
  • Provide input to strengthen preclinical data and biomarkers for advancing programs to the clinic.

Qualifications & Experience

  • PhD or PharmD related to pharmacokinetics with at least 10 years industry experience
  • Demonstrated PK/PD experience, clinical and non-clinical projects
  • Previous experience with global regulatory interactions and NDA filing experience
  • Track record of implementing MIDD approaches
  • Prior management experience

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