Senior DMPK Director – Global Pharmaceutical R&D
Location: United States
Job Type: Full-Time
Experience Required: Minimum 12 years in DMPK within the pharmaceutical industry
Industry: Drug Discovery, Preclinical Development, Translational Sciences
Job Summary
The Senior DMPK Director is responsible for leading advanced DMPK and modeling & simulation strategies to support the progression of drug candidates from discovery through development and regulatory submission. This role provides strategic leadership, scientific direction, and technical expertise across multiple programs within Exelixis’ portfolio. The Director will drive IND- and NDA-enabling ADME efforts, support regulatory documentation, and collaborate extensively with internal and external partners. This position also contributes to departmental growth and may mentor junior scientists.
Key Responsibilities
Lead IND- and NDA-enabling translational ADME programs and ensure alignment with regulatory standards.
Characterize ADME properties of drug candidates and implement in vitro to in vivo correlation strategies.
Analyze and interpret preclinical PK/PD data to inform development decisions and candidate selection.
Collaborate with Discovery teams to enhance translational ADME strategies and ensure seamless progression from Discovery to Development.
Work closely with Clinical Pharmacology and Pharmacometrics to enable effective transition of molecules into clinical stages.
Partner cross-functionally with CMC, Toxicology, Clinical Development, Translational Medicine, and Regulatory Affairs to achieve portfolio objectives.
Prepare high-quality regulatory documents including IND, CTA, NDA submissions, study protocols, and study reports.
Support due diligence evaluations and provide expert scientific assessments.
Deliver scientific presentations to leadership teams, internal stakeholders, and external partners.
Stay current with emerging DMPK research and integrate innovative approaches to advance development programs.
Contribute to scientific publications and maintain strong external visibility.
Promote a culture of innovation, accountability, collaboration, and scientific excellence.
Education & Experience Requirements
Education
PhD in Pharmacokinetics, Drug Metabolism, Pharmaceutical Sciences, or related discipline.
Minimum Experience: 12 years of relevant DMPK experience in the pharmaceutical or biotech industry.
Experience
Expert knowledge of in vitro and in vivo ADME studies.
Strong track record of managing external DMPK programs at CROs.
Extensive experience identifying clinical candidates and progressing them into clinical trials.
Solid experience using physiologically based and empirical modeling techniques for DDI and biopharmaceutics assessment.
Experience with IND/NDA/BLA and global regulatory submissions.
Experience with antibody–drug conjugates (preferred).
Technical Skills & Competencies
Deep understanding of drug metabolism, transporters, enzymology, enzyme kinetics, and IVIVE methodologies.
Strong analytical, problem-solving, and data interpretation skills.
Demonstrated scientific creativity and impact in drug discovery and development.
Proficiency integrating emerging technologies into DMPK workflows.
Excellent written and verbal communication skills for cross-functional collaboration.
Proven leadership with the ability to influence, mentor, and drive team performance.
Ability to handle complex scientific issues requiring independent judgment.
Effective in a matrixed, fast-paced research environment with multidisciplinary teams.
Work Environment
This role operates in a collaborative, modern, open-plan office designed to support scientific innovation and cross-functional teamwork. Ergonomic workstations and dual monitors are provided. Some travel may be required based on project needs.
Compensation & Benefits
Base Salary Range: USD 183,000 – 260,000 annually (varies by geographic market).
Compensation is determined by experience, location, skill set, and internal pay equity.
Comprehensive benefits package including:
401(k) with company contributions
Medical, dental, and vision insurance
Life and disability coverage
Flexible spending accounts
Annual discretionary bonus eligibility
Stock purchase program and long-term incentives
15 vacation days in the first year
17 paid holidays including a company-wide winter shutdown
Up to 10 paid sick days annually
Equal Opportunity Statement
Exelixis is an Equal Opportunity Employer committed to a diverse and inclusive workplace. All qualified applicants will be considered without regard to race, color, religion, sex, national origin, age, disability, gender identity, veteran status, or any other legally protected category.
Disclaimer
This job description outlines the primary duties and responsibilities of the role but does not encompass all tasks that may be required.
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