What You'll Do

Director/Senior Director, Clinical Pharmacology, leads pharmacometric and clinical pharmacology strategies across global pediatric drug development programs and serves as the Clinical Pharmacology lead on cross-functional teams, translating complex quantitative insights into actionable development decisions. This role oversees the design and application of population PK, PK/PD, exposure–response, and PBPK models to inform dose selection, study design, and optimization of efficacy and safety across Phase 2 and Phase 3 trials. The position also supports 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 to support global pediatric drug development programs.

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

• Conduct model-informed analyses to support study design, dose selection, and optimization of efficacy and safety for Phase 2 and Phase 3 trials in pediatric populations (0–18 years), and support 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 regulatory agencies (FDA, EMA, PMDA, etc).

• 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.

• Apply quantitative analytical tools to support early development decisions, including clinical candidate selection and first-in-human (FIH) study design (e.g., PK/PD modeling, human PK projections, and dose/exposure selection).

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

Where You'll Work

This is a U.S.-based remote role that may require quarterly or as-needed visits to our San Francisco Office.

Who You Are

• Ph.D. or Pharm.D. in Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, or a related discipline, with 10+ years of relevant experience in the biotechnology or pharmaceutical industry (or equivalent combination of education and experience).

• Demonstrated track record of hands-on modeling and simulation (M&S) across drug development, including experience supporting regulatory submissions; experience in pediatric drug development is preferred.

• Expertise 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.

• Proficiency in industry-standard pharmacometrics tools and programming languages (e.g., NONMEM, Monolix, NLME, Simcyp, R).

• Strong understanding of global regulatory expectations and guidance (e.g., FDA, EMA) related to clinical pharmacology and model-informed drug development (MIDD).

• 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.