DMPK Director

SUMMARY/JOB PURPOSE The DMPK Director has strong scientific, technical and leadership skills to develop and implement DMPK and modeling and simulation strategies to advance drug candidates from discovery to development stage and build comprehensive DMPK packages to enable successful drug registration. The director is responsible for providing strategic and technical subject matter expertise as well as scientific accountability for the DMPK support of several programs in Exelixis' portfolio. ESSENTIAL DUTIES/RESPONSIBILITIES Lead the IND- and NDA-enabling ADME work; characterize the ADME properties of molecules and collaborate to establish in vitro to in vivo correlations; ensure that all DMPK studies and analyses are consistent with regulatory guidance Analyze and interpret preclinical pharmacokinetic and pharmacodynamic data to inform drug development decisions Closely partner with Discovery to evolve translational ADME strategies and collaborate on roll-out and execution to ensure deep integration of knowledge from Discovery to Development Work collaboratively with other functional partners including Translational Medicine, CMC, Toxicology, Clinical Development and Regulatory to deliver on project and corporate objectives Prepare high quality regulatory documents including IND, CTA, and NDA filings; prepare DMPK components of nonclinical and clinical study protocols, nonclinical and clinical study reports, and investigator brochures Support functional area reviews for due diligence evaluations Conduct scientific presentations to senior management, project teams and internal/external collaborators Stay up-to-date with advancements in DMPK research and identify and integrate emerging science to advance the portfolio Maintain external scientific visibility through publications Contribute to a science-driven, goal-oriented culture that values innovation, teamwork, agility, transparency, accountability and empowerment Performs other duties as assigned Complies with all policies and standards SUPERVISORY RESPONSIBILITIES No supervisory responsibilities EDUCATION/EXPERIENCE/KNOWLEDGE/SKILLS & ABILITIES Education PhD degree in Drug Metabolism, Pharmacokinetics, Pharmaceutical Sciences or other relevant field and a minimum of 8 years of relevant experience in DMPK in the pharmaceutical industry; or, Equivalent combination of education and experience Experience Minimum 8 years experience in DMPK Expert knowledge of in vitro and in vivo ADME studies Experience managing external DMPK work at CROs Extensive experience in identifying clinical candidates through balancing ADME, pharmacology and toxicology properties and progressing molecules into clinical trials Solid experience in utilization of physiologically-based and empirical modeling and simulation techniques to characterize drug-drug interactions and biopharmaceutics liabilities Experience with submission of IND/NDA/BLA and global marketing applicatiions Experience with…