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About the role
Key responsibilities & impact- Lead clinical pharmacology and pharmacometrics strategies on cross-functional teams
- Oversee design and application of population PK, exposure–response, PK/PD, and PBPK models across clinical drug development programs, predominantly for small molecules
- Oversee external bioanalytical CROs
- Develop and implement clinical pharmacology and pharmacometrics strategies across all stages of clinical development, including pediatric programs
- Manage NCA, population PK, exposure–response, PK/PD, and PBPK modeling and simulation analyses to inform decision-making
- Support dose selection and clinical trial study design in pediatric populations
- Support global regulatory submissions and labeling
- Author and contribute to clinical pharmacology sections of regulatory documents, including IB, DSUR, briefing books, and NDA/MAA submissions
- Support interactions with global regulatory agencies
- Design clinical pharmacology studies and manage study execution and CROs/vendors
- Conduct PK data analyses and provide study-level oversight
- Author, review, and approve protocols, analysis plans, and reports
- Present results to internal teams and external stakeholders
- Contribute to scientific publications, abstracts, and conference presentations
- Communicate findings effectively to internal and external stakeholders
Requirements
What you’ll need- Ph.D. or Pharm.D. in Clinical Pharmacology, Pharmaceutical Sciences, or a related discipline
- 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
- Ability to apply modeling and quantitative approaches to inform clinical development and regulatory strategy
- 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
- Ability to translate complex quantitative findings into clear, actionable insights
- Strong written, verbal, and interpersonal communication skills
- Experience presenting to internal teams and external stakeholders
- Experience in pediatric drug development preferred
Benefits
Comp & perks- 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
- 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
- Opportunities for skill development and internal mobility
- Career pathing through regular feedback, continuous education, and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching
- Financial rewards, peer-to-peer recognition, and growth opportunities
- Annual performance bonus
- Company equity
- Generous health benefits