DMPK Director
About the role
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.
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
Qualifications
Education/Experience: 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 an 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
- Experience with antibody drug conjugates is a plus
Required Knowledge, Skills and Abilities:
- 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
Pay
The base pay range for this position is $166,500 - $236,500 annually, adjusted for geographic region, job-related knowledge, skills, experience and internal