Job Title: Senior Scientist / Principal Scientist DMPK

Work Location: San Mateo County, California

Summary:

Seeking a highly motivated and skilled DMPK Scientist to contribute expertise in small molecule drug discovery and early development. This role will guide and implement DMPK strategies, enabling data-driven decision-making throughout the lifecycle of small molecule therapeutics. The position involves cross-functional collaboration and oversight of preclinical and clinical DMPK activities.

Responsibilities:

• Act as a subject matter expert for DMPK strategy on interdisciplinary project teams, supporting small molecule drug discovery and development.
• Manage and oversee external vendors to ensure completion of in vitro and in vivo studies.
• Design and conduct preclinical in vivo studies, including PK and PK/PD modeling, simulation, and sensitivity analysis.
• Collaborate closely with biology, pharmacology, toxicology, biomarker, and clinical teams to provide human dose predictions and therapeutic index assessments.
• Oversee the transfer and implementation of modeling strategies from preclinical to clinical development phases.
• Interpret and communicate DMPK data effectively to project teams and stakeholders.
• Contribute to the preparation of regulatory documents, including Nonclinical Pharmacology sections for IND/CTA filings, IB updates, and responses to regulatory queries.
• Support timely, data-driven decision-making throughout the lifecycle of small molecule therapeutics.

Qualifications:

• MS or PhD in Drug Metabolism, Pharmacokinetics, Chemistry, or a related scientific discipline with a minimum of 5+ years of pharmaceutical drug discovery and development experience, or BSc with 10+ years of relevant experience.
• Strong critical thinking and scientific skills, with proven expertise in small molecule metabolism and pharmacokinetics.
• Demonstrated success working collaboratively on cross-functional project teams.
• Excellent oral presentation and written communication skills.
• Ability to effectively communicate DMPK data and its interpretation to diverse audiences.
• Experience writing Nonclinical Pharmacology sections for regulatory filings and responding to regulatory queries.

Published Category: Discovery Research & Preclinical