Senior Director, Clinical Pharmacology
BridgeBio
September 01, 2026
Remote friendly (San Francisco, CA)
United States
Clinical Research and Development
Senior Director, Clinical Pharmacology
Responsibilities:
- Lead clinical pharmacology and pharmacometrics strategies on cross-functional teams.
- Oversee design and application of NCA, population PK, exposure–response, PK/PD, and PBPK models across clinical development (predominantly small molecules).
- Oversee external bioanalytical CROs.
- Support regulatory strategy by authoring key clinical pharmacology documents and contributing to interactions with global health authorities.
- Manage modeling and simulation analyses to support pediatric dose selection and study design; support global regulatory submissions and labeling.
- Author/contribute clinical pharmacology sections of regulatory documents (e.g., IB, DSUR, briefing books, NDA/MAA) and support agency interactions.
- Design clinical pharmacology studies; manage execution and CROs/vendors; conduct PK analyses; oversee protocols, analysis plans, and reports.
- Present results to stakeholders (including scientific publications, abstracts, and conference presentations).
Qualifications:
- Ph.D. or Pharm.D. in Clinical Pharmacology, Pharmaceutical Sciences, or related field.
- 10+ years relevant biotech/pharma experience.
- Demonstrated track record in population PK, PK/PD, mechanistic modeling (PBPK), and quantitative data analysis; pediatric drug development experience preferred.
- Strong knowledge of global regulatory guidances for clinical pharmacology, MIDD, bioanalytical method validation, and GLP/GxP.
- Excellent analytical thinking and written/verbal communication.
Benefits (U.S. full-time):
- Market-leading compensation; 401(k) match; ESPP; HSA/FSA; employer-paid medical/dental/vision premiums; flexible PTO/holidays; paid medical and parental leave.
Salary (CA): $265,000–$289,000 USD.
Work: Hybrid; in-office 2–3x/week in San Francisco.
Responsibilities:
- Lead clinical pharmacology and pharmacometrics strategies on cross-functional teams.
- Oversee design and application of NCA, population PK, exposure–response, PK/PD, and PBPK models across clinical development (predominantly small molecules).
- Oversee external bioanalytical CROs.
- Support regulatory strategy by authoring key clinical pharmacology documents and contributing to interactions with global health authorities.
- Manage modeling and simulation analyses to support pediatric dose selection and study design; support global regulatory submissions and labeling.
- Author/contribute clinical pharmacology sections of regulatory documents (e.g., IB, DSUR, briefing books, NDA/MAA) and support agency interactions.
- Design clinical pharmacology studies; manage execution and CROs/vendors; conduct PK analyses; oversee protocols, analysis plans, and reports.
- Present results to stakeholders (including scientific publications, abstracts, and conference presentations).
Qualifications:
- Ph.D. or Pharm.D. in Clinical Pharmacology, Pharmaceutical Sciences, or related field.
- 10+ years relevant biotech/pharma experience.
- Demonstrated track record in population PK, PK/PD, mechanistic modeling (PBPK), and quantitative data analysis; pediatric drug development experience preferred.
- Strong knowledge of global regulatory guidances for clinical pharmacology, MIDD, bioanalytical method validation, and GLP/GxP.
- Excellent analytical thinking and written/verbal communication.
Benefits (U.S. full-time):
- Market-leading compensation; 401(k) match; ESPP; HSA/FSA; employer-paid medical/dental/vision premiums; flexible PTO/holidays; paid medical and parental leave.
Salary (CA): $265,000–$289,000 USD.
Work: Hybrid; in-office 2–3x/week in San Francisco.