Director/Sr. Director Clinical Pharmacology

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.

Requirements

• 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.

Qualifications

• 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.

Skills

• Pharmacokinetics
• Pharmacometrics
• Population PK
• PK/PD
• Mechanistic Modeling (PBPK)
• Quantitative Data Analysis
• Industry-standard Pharmacometrics Tools
• Programming Languages (NONMEM, Monolix, NLME, Simcyp, R)
• Global Regulatory Expectations
• Model-Informed Drug Development (MIDD)
• Written Communication
• Versatile Communication
• Interpersonal Communication

Benefits

• 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
• Health & Well-Being: 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)
• Caregiving support
• Comprehensive paid medical and parental leave to care for yourself and your family
• Skill Development & Career Paths: regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching
• Peer-to-peer recognition
• Growth opportunities

Pay

$262,800 - $284,800 USD

Schedule

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