Director, Pharmacokinetics & Bioanalysis

Role: Director of Translational Science/Pharmacokinetics, responsible for shaping PK, DMPK, bioanalysis, and translational PK/PD strategies across the company's portfolio. Main objectives include leading cross-functional efforts from discovery through clinical development, guiding candidate selection, dose planning, and regulatory submissions based on PK insights. Responsibilities encompass designing and interpreting nonclinical and clinical PK/PD studies, managing external partners such as CROs and labs, and authoring regulatory documents like INDs and CTAs. The role requires translating complex PK data into strategic development guidance and representing PK interests in cross-functional teams.

Qualifications: Advanced degree in pharmaceutical sciences, pharmacology, or related field, with 10+ years industry experience in pharmacokinetics, drug metabolism, or clinical pharmacology. Proven impact across drug discovery and development stages, with strong scientific communication skills and experience with regulatory interactions. Preferred skills include modeling and simulation expertise, team leadership, and mentoring.

High-Value Details: Focus on biologics or small molecules, with involvement from discovery through clinical phases; some travel (~30%) expected. Position based in Irvine with hybrid/remote options. Reports to VP, Translational Science, and collaborates across discovery, nonclinical, clinical, and regulatory functions. Emphasizes innovation through external partnerships, AI, and new methodologies, aiming to accelerate development and improve decision-making in biopharma drug programs.