Associate Director, Clinical Pharmacology

Role: Associate Director of Clinical Pharmacology responsible for designing, leading, and implementing clinical pharmacology strategies across clinical programs for rare diseases. Objectives include optimizing dosing regimens, integrating PK/PD and drug-drug interaction assessments into trials, and supporting regulatory submissions. Responsibilities encompass developing clinical pharmacology studies, providing expert input for IND, CTA, NDA filings, and collaborating with R&D functions to ensure strategic pharmacology guidance at key development milestones. Qualifications: Ph.D. or equivalent with 4+ years (or PharmD with 8+ years) experience in clinical pharmacology, demonstrated leadership in PK/PD, biopharmaceutics, and modeling across development phases, and experience in rare disease therapeutic areas. Skills include project management, cross-functional collaboration, scientific data interpretation, and regulatory document preparation. High-Value: Rare disease focus, clinical pharmacology expertise, early to late-stage development, and experience in modeling-informed drug development (MIDD). Work Setup: Hybrid, based in San Diego, with approximately 10% domestic and international travel; onsite presence required for face-to-face work.