Director, DMPK & Translational Modeling Strategy

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

Benefits offered by this job

401k plan

Medical/Dental/Vision coverage

Life and disability insurance

Stock purchase plan

Vacation and holidays

Job summary

Exelixis Inc. seeks a DMPK Director to lead ADME and modeling strategies across discovery to development, enabling regulatory submissions and robust translational science.

You will ensure scientific accountability and strategic DMPK direction for multiple programs in Exelixis' portfolio. The role requires a PhD with 8+ years in DMPK, deep regulatory knowledge, and the ability to lead cross-functional teams in a fast-paced biotech environment.

Qualifications

• PhD in Drug Metabolism or related field with 8+ years in DMPK.
• Experience managing external DMPK work at CROs.
• Experience with IND/NDA/BLA submissions and regulatory filings.
• Strong collaboration and communication across multidiscliplinary teams.

Responsibilities

• Lead IND- and NDA-enabling ADME work and develop in vitro to in vivo correlations.
• Interpret preclinical PK/PD data to inform development decisions.
• Collaborate with Discovery and Translational Medicine to align ADME strategies.
• Prepare regulatory documents and DMPK sections of study protocols/reports.
• Support due diligence reviews and scientific presentations to senior management.

Skills

DMPK expertise

ADME

PK/PD

Translational science

Education

PhD in DMPK

Job description

Exelixis Inc. seeks a DMPK Director to lead ADME and modeling strategies across discovery to development, enabling regulatory submissions and robust translational science.

You will ensure scientific accountability and strategic DMPK direction for multiple programs in Exelixis' portfolio. The role requires a PhD with 8+ years in DMPK, deep regulatory knowledge, and the ability to lead cross-functional teams in a fast-paced biotech environment.