Director/Sr. Director Clinical Pharmacology

Role: Director/Senior Director, Clinical Pharmacology, leading pharmacometric strategies in pediatric drug development for rare diseases. Responsibilities include designing and applying population PK, PK/PD, exposure–response, and PBPK models to inform dose selection, study design, and efficacy/safety optimization across Phase 2 and 3 trials; authoring regulatory documents; supporting regulatory interactions; overseeing clinical pharmacology studies and CROs; and translating complex data into actionable insights for internal teams and external stakeholders. Requirements: Ph.D. or Pharm.D. with 10+ years in biotech/pharma; expertise in modeling and simulation tools (e.g., NONMEM, Monolix, R); strong understanding of regulatory expectations (FDA, EMA); proven pediatric drug development experience preferred; excellent analytical, communication, and leadership skills. HighValue: pediatric populations (0–18 years), rare disease focus, model-informed drug development (MIDD), global regulatory engagement, remote work with quarterly site visits in San Francisco. Work setup: remote US-based role with occasional in-person meetings.