Senior DMPK Director – Alameda, CA, USA
Location: Alameda, California, USA
Category: Clinical Pharmacology / Drug Metabolism & Pharmacokinetics (DMPK)
Employment Type: Full-Time
Experience Required: Minimum 12 years in DMPK within pharmaceutical or biotechnology industry
About the Role
Exelixis is seeking an experienced Senior DMPK Director with strong scientific, technical, and leadership expertise to advance drug candidates from discovery through development. The Senior Director will develop and implement DMPK strategies and modeling & simulation approaches, ensuring comprehensive drug metabolism and pharmacokinetics packages to support successful drug registration. This role provides strategic and technical oversight, scientific accountability, and mentorship to junior scientists while contributing to the growth of the Clinical Pharmacology and Pharmacometrics department.
Key Responsibilities
Lead translational IND- and NDA-enabling ADME programs, characterizing absorption, distribution, metabolism, and excretion properties of molecules.
Develop in vitro to in vivo correlations and ensure DMPK studies comply with regulatory guidance.
Analyze and interpret preclinical PK/PD data to inform strategic drug development decisions.
Collaborate closely with Discovery, Clinical Pharmacology, and Pharmacometrics teams for seamless molecule transition into development.
Partner with Translational Medicine, CMC, Toxicology, Clinical Development, and Regulatory teams to deliver project and corporate objectives.
Prepare high-quality regulatory submissions including INDs, CTAs, NDAs, and DMPK sections of nonclinical and clinical study reports.
Conduct scientific presentations to senior management, project teams, and internal/external collaborators.
Integrate emerging DMPK science to advance the portfolio and maintain external scientific visibility through publications.
Foster a science-driven culture emphasizing innovation, teamwork, agility, and accountability.
Ensure compliance with company health, safety, and laboratory practices.
Required Qualifications
PhD in Pharmacokinetics, Drug Metabolism, Pharmaceutical Sciences, or related field.
Minimum 12 years of DMPK experience in pharmaceutical or biotech industry.
Expert knowledge of in vitro and in vivo ADME studies.
Proven experience managing DMPK work at CROs.
Strong background in candidate selection, balancing ADME, pharmacology, and toxicology properties.
Extensive experience with physiologically-based modeling, empirical simulations, and characterization of drug-drug interactions and biopharmaceutics liabilities.
Experience preparing IND, NDA, BLA, and global marketing applications.
Knowledge of antibody-drug conjugates is a plus.
Deep understanding of drug metabolism, drug transporters, enzyme kinetics, and in vitro to in vivo extrapolation.
Demonstrated ability to apply emerging science to strengthen research capabilities.
Excellent leadership, collaborative, verbal, and written communication skills.
Experience in matrixed, multidisciplinary teams in a fast-paced environment.
Compensation & Benefits
Base Salary: $183,000 – $260,000 (adjusted based on location, experience, and internal equity).
Participation in discretionary annual bonus programs or sales-based incentives (if applicable).
401(k) retirement plan with generous company contributions.
Comprehensive medical, dental, and vision coverage, life and disability insurance.
Flexible spending accounts for health and dependent care.
Employee stock purchase plan and long-term incentives.
Paid vacation (15 days first year), up to 17 holidays including company-wide winter shutdown, and up to 10 sick days per year.
Why Join Exelixis?
Exelixis is committed to driving scientific innovation in oncology and therapeutic development. We provide a collaborative and supportive work environment, where individuals can make meaningful contributions to advancing life-changing medicines.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, veteran status, disability, or any other legally protected category.
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