Senior Director, Clinical Pharmacology

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.