DMPK Director

Exelixis; Alameda (CA); On-site; USD 167,000 - 237,000; Full time

Benefits offered by this job

401k plan

Medical, dental, vision insurance

Life and disability insurance

Flexible spending accounts

Stock purchase plan

Paid holidays

Job summary

Exelixis is seeking a DMPK Director to lead strategy and execution across ADME, PK/PD and translational DMPK for multiple programs. The role requires deep scientific leadership, regulatory familiarity, and collaboration with Discovery, Translational Medicine, and Regulatory teams.

You will oversee external CROs, drive modeling and simulation to support decision making, and contribute to regulatory submissions for preclinical and clinical programs.

Qualifications

• PhD in relevant field with 8+ years in DMPK or equivalent experience.
• Experience leading IND/NDA-enabling ADME programs and cross-functional collaboration.
• Strong knowledge of PK/PD, in vitro/in vivo extrapolation, and regulatory expectations.

Responsibilities

• Lead IND- and NDA-enabling ADME work and in vitro to in vivo correlations.
• Analyze preclinical PK/PD data to inform development decisions.
• Collaborate with Discovery to advance translational ADME strategies.
• Partner with Translational Medicine, CMC, Toxicology, Clinical Development and Regulatory.
• Prepare regulatory documents including IND, CTA, and NDA filings.

Skills

DMPK expertise

PK/PD analysis

Translational science

Regulatory knowledge

Leadership & matrix teamwork

External vendor management

IND/NDA familiarity

Biopharmaceutics modeling

Education

PhD in Drug Metabolism or Pharmacokinetics

Equivalent education/experience

Tools

Modeling & Simulation software

CRO management tools

Job description

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.

• 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
• 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

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 standards

Supervisory 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 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 applicatiions
• Experience with antibody drug conjugates is a plus

Knowledge, Skills and Abilities

• 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 severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $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 candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

If you have a disability and need an accommodation in relation to the recruiting process, please email us at: [e-mail].

Working Conditions

Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

Disclaimer

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.