Senior Scientist (Drug Metabolism & Pharmacokinetics)

Roche•South San Francisco, CA

82d•$124,300 - $230,900•Onsite

About The Position

The Drug Metabolism & Pharmacokinetics (DMPK) department at Genentech is seeking a highly motivated leader who will be supporting small molecule projects in discovery and development. The DMPK group is dedicated to enabling the discovery, development and commercialization of safe and effective medicines by elucidating the absorption, distribution, metabolism, excretion and pharmacokinetic properties of traditional small molecule and emerging modality drug candidates. We accomplish this through the application of state-of-the-art technologies and sciences of bioanalysis, drug metabolism, drug transport and pharmacokinetics. The DMPK group works in close partnership with disciplines such as medicinal chemistry, pharmacology, toxicology, pharmaceutical sciences, clinical pharmacology and regulatory to optimize leads, select clinical candidates, conduct preclinical development studies, support clinical evaluation and contribute to IND and NDA filings. The Opportunity The individual would lead the DMPK strategy, design and oversee non-clinical studies in a highly collaborative project team environment. Specifically, the individual will be involved in the following activities as part of their role: Serve as the DMPK representative on multidisciplinary project teams and communicate recommendations to project teams. Lead DMPK strategy and author or review relevant sections of regulatory briefing packages/filings. Design, oversee, interpret and integrate in vitro and in vivo ADME, PK and translate nonclinical data into human PK and dose predictions. Identify DMPK-related risks, and develop mitigation strategies.

Requirements

PhD in pharmacokinetics, drug metabolism, pharmaceutical sciences or related discipline.
At least 2 years of relevant pharmaceutical industry experience as a DMPK project leader.
Strong knowledge of ADME, PK, and the integration of DMPK data into discovery and development decisions.
Experience designing, interpreting and integrating nonclinical DMPK studies.
Ability to communicate complex scientific data, uncertainties and recommendations clearly to multidisciplinary teams and senior stakeholders.

Nice To Haves

Experience as a member/leader of multi-functional project teams supporting diverse modalities (small/large molecules, peptides, degraders, conjugates etc.), in particular, those outside Lipinski’s Rule-of-5.
Experience supporting programs through candidate selection, IND-enabling development, clinical development or regulatory interactions.
Hands-on experience with PK/PD modeling and/or PBPK modeling using relevant modeling and simulation platforms are highly desired.

Responsibilities

Serve as the DMPK representative on multidisciplinary project teams and communicate recommendations to project teams.
Lead DMPK strategy and author or review relevant sections of regulatory briefing packages/filings.
Design, oversee, interpret and integrate in vitro and in vivo ADME, PK and translate nonclinical data into human PK and dose predictions.
Identify DMPK-related risks, and develop mitigation strategies.