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.