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.

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.

Market-leading compensation
401(k) with employer match
Employee Stock Purchase Program (ESPP)
Pre-tax commuter benefits (transit and parking)
Referral bonus for hired candidates
Subsidized lunch and parking on in-office days
100% employer-paid medical, dental, and vision premiums for you and your dependents
Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
Fertility & family-forming benefits
Expanded mental health support (therapy and coaching resources)
Hybrid work model with flexibility
Flexible, “take-what-you-need” paid time off and company-paid holidays
Comprehensive paid medical and parental leave to care for yourself and your family

Senior Director, Clinical Pharmacology

Key skills