Senior/Principal Scientist, Clinical Pharmacology and Nonclinical DMPK

San Francisco, CA | Full Time | Translational Medicine

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Job Description

Job Summary

 Reporting to the head of Clinical & Nonclinical Pharmacology, the Senior/Principal Scientist, Clinical Pharmacology and Nonclinical DMPK lends support to all phases of drug development under minimum supervision. This will be accomplished by working in close partnership with other functions, including Translational medicine, Toxicology, Clinical Operations, Clinicians, Biostatisticians, Regulatory function, Marketing and Medical Affairs.

This position requires the experience and ability to develop and adapt integrated clinical pharmacology strategies for Clovis compounds based on comprehensive understanding of clinical and non-clinical data of drug pharmacokinetics, drug-drug interaction, pharmacology, efficacy, and safety. The candidate is required to have hands-on experience in modeling-aided drug development, and will lead and/or contribute to population PK analysis, selection of optimal regimens, exposure-response analysis, etc. He/she will design and execute high quality nonclinical DMPK studies (in vitro and in vivo) and Clinical Pharmacology studies to support clinical drug development in all stages in a timely manner. 

Job Responsibilities

  • Develop and refine nonclinical DMPK and Clinical Pharmacology plans
  • Represent Nonclinical DMPK and Clinical Pharmacology in various teams
  • Plan and design animal and in vitro studies, and supervise CROs to ensure timely and high-quality non-clinical DMPK and DDI characterization
  • Contribute to the Clinical Pharmacology study design, statistical analysis plans, and be responsible for PK/PD data analysis, interpretation, and reporting
  • Contribute to PPK and ER modeling plans and work with external modeling consultants/CROs to execute the analyses
  • Provide Clinical Pharmacology and nonclinical DMPK support to clinical and regulatory documents such as IB, IND, IMPD, NDA, MAA, etc.
  • Lead or contribute to publications in peer-reviewed journal articles and at conference meetings and provide cross-function education within project teams
  • Contribute to CRO selection and evaluation
  • Contribute to budget planning, and manage internal (cross functional and within function) and external resources (consultants and CROs) to ensure delivery on time and on quality
  •  Provide Clinical Pharmacology support to investigator-initiated, Partner-initiated, and Global Medical Affairs-initiated clinical studies as needed

Skills & Requirements

Qualifications

  • Demonstrated ability to represent nonclinical DMPK and Clinical Pharmacology in project teams. Experience in small-molecule anti-cancer drug clinical development is mandatory. Experience with additional therapeutic modalities including monoclonal antibodies, small molecule/protein conjugates considered a plus.
  • A deep understanding of PK/PD and first-hand experience of modeling-aided drug development.
  • Hands-on experience with standard PK software including WinNonlin and NONMEM. First-author modeling publications are highly desirable.  Experience with other software such as S-Plus/R is a plus.
  • Ability to plan, organize, and critically assess and/or perform PK/PD data analyses.
  • Experience in hands-on preparation of regulatory applications (IND, CTD, NDA/BLA) is highly desirable.  Global development experience is a plus. 
  • Knowledge of GLP/GCP and regulatory guidelines.
  • Excellent oral and written communication skills.
  • Demonstrated ability to collaborate and work effectively in cross-functional project teams is essential.
  • Experience in managing external contract research vendors and consultants is a plus

Education and Experience

  • PhD or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Pharma D, Pharmacology or related disciplines.
  • Must have a comprehensive understanding of principals of PK, drug metabolism, drug-drug interaction, and PK/PD assessment from at least 4-8 years of industry and/or post-doctoral experience in clinical pharmacology. 

Working Conditions

  • Office based position with limited travel required (<10%)