1-617-500-6690 [email protected]

Company:  Confidential

Job Title: Director/Senior Director, DMPK

Job Number: 31912

Location: San Diego, CA

Job Description

The DMPK Director/Senior Director will support the rich pipeline of drug discovery, IND-enabling, and clinical programs. The focus will be to lead ADME contributions across  drug discovery and development portfolio. This position will collaborate with and influence cross-functional teams to identify and mitigate challenges related to PK, metabolism, assessment of DDIs, IND-enabling ADME, toxicology, PK/PD studies, and human dose projections. Additionally, this role will assist with the development of scientific strategies and continue to build partnerships cross-functionally to advance both research and clinical programs.

Responsibilities

  • Guide DMPK activities across multiple project phases, including lead discovery, lead optimization, and regulatory filings.
  • Supervise a DMPK team focused on the preclinical support of drug programs.
  • Participate in the selection and management of CROs for the conduct of in vitro and in vivo ADME studies, including IND-enabling studies and studies to support clinical development.
  • Partner with and support medicinal chemistry, toxicology, regulatory, clinical, project management, and other departments by implementing ADME strategies that meet program goals and regulatory requirements.
  • Develop a cutting-edge infra-structure including in-house capabilities that leverage automation and robotics, electronic lab notebooks, and collaborative IT tools.
  • Design and execute preclinical studies to understand the PK and ADME of drug candidates.
  • Oversee the analysis, interpretation, integration, and reporting of preclinical DMPK data generated both internally and using external vendors.
  • Provide expertise in human PK and dose prediction of drug candidates using different approaches.
  • Author high-quality regulatory documents including INDs, CTAs, NDAs, and other regulatory filings

Required Skills

  • Ph.D. in Drug Metabolism, Pharmacokinetics, Pharmaceutical Chemistry, or a related scientific discipline, with a minimum of 8+ years of biotech/pharmaceutical drug discovery and development experience.
  • Experience in serving as the lead ADME/PK representative on discovery, lead optimization and development teams, and applying DMPK concepts to the function of those teams.
  • Strong knowledge of drug metabolism and pharmacokinetics principles.
  • Ability to plan, organize, and critically assess and/or perform PK/PD data analyses.
  • Knowledge of the latest technological and regulatory advances in the DMPK arena and demonstrated strong interest and expertise in PK and physicochemical property modeling techniques.
  • Demonstrated capability to mentor junior scientists and manage in a matrix environment.
  • Build strong relationships with peers and partners outside of DMPK to enable high team performance.
  • San Diego CA based position

 

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