Exec Director, Drug Metabolism

Role Summary

Executive Director, Drug Metabolism and Pharmacokinetics (DMPK) leads PK strategy for biologics, providing scientific leadership on large‑molecule discovery and development teams. The role encompasses design, supervision, and interpretation of ADME experiments to characterize absorption, distribution, metabolism, and excretion of biologic therapeutics. It also includes project representation within the DMPK department and opportunities to participate in business development and external research initiatives.

Location:

Foster City, CA.

• Serve on project teams at various stages of discovery and development as a subject matter expert and scientific leader for DMPK Biologics, providing PK or PK/PD expertise to the design of nonclinical PK, toxicology, or pharmacology studies.
• Participate in business development and licensing evaluations.
• Prepare study protocols and coordinate execution of nonclinical studies which may involve multiple functional areas and CROs.
• Design and perform complex PK‑PD analysis to answer translational questions in support of project deliverables and first‑in‑human dose predictions.
• Interpretation and strategy for evaluating the impact of anti‑drug antibody (ADA).
• Work closely with project teams, line management and CROs to assure high quality and timely delivery of written PK reports and regulatory documents (IND, IMPD, IB, BLA) for regulatory submissions.
• Supervising of research scientists and associate scientists may be required.

• Requires a highly motivated individual with a PhD and 20+ years of post‑graduate industry experience in pharmacokinetics, drug metabolism, pharmaceutics, or related life science field primarily supporting the PK characterization of large molecule/biologics through discovery and development.
• Applicant must demonstrate excellent verbal and technical communication, independent scientific thinking, with the ability to interpret results, determine next steps and present data to project teams and senior management.
• Applicant must demonstrate intellectual curiosity and propensity to stay current with latest advances in DMPK of biologics and PK analysis with a proven track record of sustained external visibility through publications, presentations and/or involvement in professional organizations.
• Applicant must be highly experienced in the application of PK‑PD and multi‑compartmental modeling.
• Knowledge in the application of large molecule/biologics ligand binding assays and LC/MS bioanalysis is highly desirable.