DMPK Director: Translational PK/PD & IND/NDA Strategy

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

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.