DMPK Director

$166.5k - $236.5k

Exelixis Inc

Exelixis seeks a DMPK Director to lead drug metabolism and pharmacokinetic strategies across the development pipeline. The role requires developing ADME packages, interpreting preclinical data, and collaborating across functional teams to advance candidates through regulatory submission and approval.

Responsibilities

Lead IND- and NDA-enabling ADME work and establish in vitro to in vivo correlations for molecular characterization
Analyze and interpret preclinical pharmacokinetic and pharmacodynamic data to inform development decisions
Collaborate with Discovery, Translational Medicine, CMC, Toxicology, and Clinical Development on project objectives
Prepare regulatory documents including IND, CTA, and NDA filings and study-related sections
Present scientific findings to senior management and external collaborators; maintain external visibility through publications

Requirements

PhD in Drug Metabolism, Pharmacokinetics, Pharmaceutical Sciences, or related field
Minimum 8 years of pharmaceutical industry DMPK experience
Expert knowledge of in vitro and in vivo ADME study design and execution
Experience managing external DMPK work and collaborating with CROs
Demonstrated expertise in physiologically-based and empirical modeling and simulation techniques
Experience with IND, NDA, BLA, and global marketing application submissions
Strong knowledge of drug metabolism, transporters, enzyme kinetics, and in vitro to in vivo extrapolation

Compensation: $166,500 - $236,500 base annually

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Vacancy posted a month ago

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