Senior Director, Clinical Pharmacology

What You'll Do

Senior Director, Clinical Pharmacology, leading clinical pharmacology and pharmacometrics strategies on cross-functional teams. This role will have oversight over the design and application of population PK, exposure-response, PK/PD, and PBPK models at various stages of the clinical drug development programs for predominantly small molecules. This role will also have oversight over external bioanalytical CROs. The position will also support regulatory strategy by authoring key clinical pharmacology documents and contributing to interactions with global health authorities, while effectively communicating findings to internal and external stakeholders.

Responsibilities

Develop and implement clinical pharmacology and pharmacometrics strategies across all stages of clinical development including pediatric development programs.

Manage the design, development, and application of NCA, population PK, exposure-response, PK/PD, and PBPK models to inform decision-making across programs.

Oversee modeling and simulation-based analyses to support dose selection and study design for clinical trials in pediatric populations, and support global regulatory submissions and labeling.

Author and contribute to clinical pharmacology sections of regulatory documents (e.g., IB, DSUR, briefing books, NDA/MAA submissions) and support interactions with global regulatory agencies.

Design clinical pharmacology studies and manage study execution and CROs/vendors. Conduct PK data analyses, provide study-level oversight, including authoring, review, and approval of protocols, analysis plans, and reports.

Present results to internal teams and external stakeholders, including contributions to scientific publications, abstracts, and conference presentations.

Where You'll Work

This is a hybrid role and requires in-office collaboration 2-3x per week in our San Francisco Office.

Who You Are

Ph.D. or Pharm.D. in Clinical Pharmacology, Pharmaceutical Sciences, or a related discipline, with 10+ years of relevant experience in the biotechnology or pharmaceutical industry.

Demonstrated track record in population PK, PK/PD, mechanistic modeling (e.g., PBPK), and quantitative data analysis, with a proven ability to apply these approaches to inform clinical development and regulatory strategy; experience in pediatric drug development is preferred.

Strong understanding of global regulatory guidances related to clinical pharmacology, model-informed drug development, bioanalytical method validation, and GLP/GxP regulations.

Excellent analytical, critical thinking, and problem-solving skills, with the ability to translate complex quantitative findings into clear, actionable insights.

Strong written, verbal, and interpersonal communication skills, with experience presenting to internal teams and external stakeholders.