Role Summary
Senior Director, Drug Metabolism and Pharmacokinetics (DMPK) responsible for providing expert PK support for biologics and serving as a DMPK project representative on discovery and development teams. Will work closely with discovery bioanalytical, protein therapeutics, nonclinical toxicology, clinical pharmacology, pharmaceutical sciences, business development and regulatory teams to nominate candidates for clinical evaluation and contribute to regulatory filings. Location: Foster City, CA.
Responsibilities
- Serve on project teams at various stages of discovery and development as a subject matter expert for DMPK Biologics, providing PK or PK/PD expertise to the design of nonclinical PK, toxicology, or pharmacology studies.
- 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).
- Participate in business development and licensing evaluations.
- 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.
Qualifications
- Requires a PhD and 14+ years of post-graduate industry experience in the fields of pharmacokinetics, drug metabolism, pharmaceutics, or related life science field primarily supporting the PK characterization of large molecule/biologics through discovery and development.
- 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.
- 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.
- Highly experienced in the application of PK-PD and multi-compartmental modeling software systems such as Phoenix/WinNonlin, MATLAB/Simbiology, or similar.
- Knowledge in the application of large molecule/biologics ligand binding assays and LC/MS bioanalysis is highly desirable.
Skills
- Proficiency with PK-PD and multi-compartmental modeling software (e.g., Phoenix/WinNonlin, MATLAB/SimBiology) to analyze and interpret complex data.
- Strong verbal and written communication; ability to present data to project teams and senior management.
- Knowledge of large molecule/biologics ligand binding assays and LC/MS bioanalysis.
- Ability to work effectively in cross-functional teams and manage project timelines and deliverables.
Education
- PhD in pharmacokinetics, drug metabolism, pharmaceutics, or related life science field.