DMPK Director, Translational PK/PD Strategy

Exelixis, Inc.; Alameda (CA); Hybrid; USD 167,000 - 237,000; Full time

Benefits offered by this job

401k plan with company contributions

Medical, dental, and vision coverage

Life and disability insurance

Flexible spending accounts

Job summary

Exelixis, Inc. is seeking a DMPK Director to develop and drive DMPK and modeling strategies from discovery through development.

You will lead IND- and NDA-enabling ADME work, interpret PK/PD data, and partner with Discovery and other functions to translate translational knowledge into program decisions. The role requires a PhD with 8+ years in DMPK, strong regulatory experience, and a track record of advancing candidates to clinical trials.

Qualifications

• PhD with 8+ years in DMPK in pharma industry.
• Expert knowledge of in vitro and in vivo ADME studies.
• Experience managing external DMPK CRO work.
• Track record of progressing molecules to clinical trials.

Responsibilities

• Lead IND- and NDA-enabling ADME work and develop IVIVC correlations.
• Interpret preclinical PK/PD data to inform development decisions.
• Collaborate with Discovery to translate ADME insights to Development.
• Prepare regulatory documents and study reports for filings.
• Present scientific updates to senior management and teams.

Skills

ADME expertise

DMPK leadership

Regulatory experience

PK/PD knowledge

Cross-functional collaboration

Education

PhD in Drug Metabolism/Pharmacokinetics/Pharmaceutical Sciences or related field

Tools

PBPK modeling

Job description

Exelixis, Inc. is seeking a DMPK Director to develop and drive DMPK and modeling strategies from discovery through development.

You will lead IND- and NDA-enabling ADME work, interpret PK/PD data, and partner with Discovery and other functions to translate translational knowledge into program decisions. The role requires a PhD with 8+ years in DMPK, strong regulatory experience, and a track record of advancing candidates to clinical trials.