Bridgebio

Senior Director, Clinical Pharmacology

San Francisco Bay Area, CA/Hybrid. Posted 2 months ago

The role

This role leads clinical pharmacology and pharmacometrics strategies on cross-functional teams. You will oversee the design and application of various models for clinical drug development programs and manage external bioanalytical CROs.

What you will do

  • 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.
  • Oversee modeling and simulation-based analyses to support dose selection and study design for clinical trials in pediatric populations.
  • Support global regulatory submissions and labeling.
  • Author and contribute to clinical pharmacology sections of regulatory documents.
  • 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.
  • Present results to internal teams and external stakeholders.
  • Contribute to scientific publications, abstracts, and conference presentations.

Required qualifications

  • 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
  • Track record in population PK, PK/PD, mechanistic modeling (e.g., PBPK), and quantitative data analysis
  • Understanding of global regulatory guidances related to clinical pharmacology, model-informed drug development, bioanalytical method validation, and GLP/GxP regulations
  • Analytical, critical thinking, and problem-solving skills
  • Written, verbal, and interpersonal communication skills

Nice to have

  • experience in pediatric drug development

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
  • 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
  • Flexible, “take-what-you-need” paid time off and company-paid holidays

About the company

BridgeBio uses a model that pools projects and early-stage research from academia to reduce risk and develop medicines for rare diseases. The company values curiosity, experimentation, and the use of AI to improve work quality.

Senior Director, Clinical Pharmacology at Bridgebio | JobZoey