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. #J-18808-Ljbffr Scorpion Therapeutics