VP, NonClinical Safety and Pathobiology

Role: Lead the Nonclinical Safety and Pathobiology (NSP) group at Gilead, overseeing design, implementation, and analysis of nonclinical programs to support drug development from research through registration. Responsibilities: manage and mentor Ph.D.-level toxicologists and pathologists; ensure compliance with global regulations; prepare regulatory documents such as INDs, IMDs, NDAs, and MAAs; oversee safety evaluations, pathobiology characterization, and translational studies; and communicate cross-functionally to meet development goals. Requirements: Ph.D. in pharmacology, toxicology, pathology, or related field; at least 20 years of experience in pharmaceutical research or development; expertise in nonclinical programs, regulatory guidelines, and safety assessment; professional certifications like DABT, DACVP, or ERT preferred; strong leadership and organizational skills; recognized as an expert in nonclinical safety. High-Value: focus on drug candidates supporting treatments for HIV, hepatitis, COVID-19, and cancer; experience with GLP toxicity studies, regulatory filings, and global regulatory environments (US, EU, AsiaPac). Work Setup: not specified; requires global collaboration.