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 standardsSUPERVISORY 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 DMPKExpert knowledge of in vitro and in vivo ADME studies

Experience managing external DMPK work at CROsExtensive 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 antibody drug conjugates is a plus

Knowledge, Skills and Abilities Required:

Extensive scientific and technical knowledge around drug metabolism and drug transporters, including enzymology and enzyme kinetics and in virto 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

Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $166,500 - $236,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the…