Senior Director, Clinical Pharmacology

About the Role

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.

Qualifications

• 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.

Pay

Salary range for candidates in California: $265,000 - $289,000 USD.

Benefits

Financial & Rewards:

• 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)
• 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

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities