DMPK Director

Exelixis•Alameda, CA

1d•$166,500 - $236,500•Onsite

About The Position

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.

Requirements

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
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 applications
Extensive scientific and technical knowledge around drug metabolism and drug transporters, including enzymology and enzyme kinetics and in vitro to in vivo extrapolation
Demonstration of independent thought/creativity in science and drug discovery
Experience in applying emerging science and technologies to strengthen and improve research capabilities
In-depth knowledge of current practices and issues in DMPK (including regulatory requirements), PKPD and translational sciences
Excellent collaborative verbal and written communication skills
Able to work well with multi-disciplinary teams
Works on problems of diverse scope where analysis and review of data requires evaluation of identifiable factors. Works on ADME complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
Exercises independent judgment in selecting methods, techniques and evaluation criteria for obtaining results
Thrives in a fast-paced business environment
Function is a highly matrixed team environment
Find creative solutions to unique and complex problems

Nice To Haves

Experience with antibody drug conjugates is a plus

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