Senior Director DMPK
Senior Director, DMPK (Drug Metabolism & Pharmacokinetics)
Location: San Francisco Bay Area (Hybrid or Remote Options Available)
Industry: Clinical-Stage Biopharmaceutical | Oncology Focus
Overview
A leading and well-capitalized clinical-stage biopharmaceutical company, is seeking a Senior Director of DMPK to lead and shape drug metabolism and pharmacokinetics strategies across a dynamic oncology pipeline. This is a high-impact leadership role for a seasoned scientist with deep expertise in ADME, translational sciences, and regulatory strategy.
Position Summary
The Senior Director will be responsible for developing and executing DMPK and modeling & simulation strategies to support the advancement of drug candidates from discovery through development and registration. This individual will serve as a key scientific leader, collaborating across functions and contributing to regulatory submissions, strategic planning, and scientific innovation.
Key Responsibilities
- Lead IND- and NDA-enabling ADME strategies and ensure regulatory alignment
- Analyze and interpret preclinical PK/PD data to guide development decisions
- Collaborate with discovery teams to evolve translational ADME strategies
- Partner with Clinical Pharmacology and Pharmacometrics to ensure seamless transition of molecules into development
- Contribute to regulatory documentation including IND, CTA, and NDA filings
- Support due diligence evaluations and cross-functional project planning
- Present scientific findings to internal stakeholders and external collaborators
- Stay current with advancements in DMPK and integrate emerging science into development strategies
- Foster a collaborative, innovation-driven culture aligned with company values
Qualfications
- PhD in Pharmacokinetics, Drug Metabolism, Pharmaceutical Sciences, or related field
- 12+ years of industry experience in DMPK, with a strong track record in oncology drug development
- Expertise in in vitro and in vivo ADME studies and in vitro to in vivo extrapolation
- Experience managing external CROs and global regulatory submissions (IND/NDA/BLA)
- Proficiency in modeling and simulation techniques (e.g., PBPK, DDI, biopharmaceutics)
- Familiarity with antibody-drug conjugates is a plus
- Strong leadership, communication, and cross-functional collaboration skills
- Demonstrated ability to work in a matrixed, fast-paced environment
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