Director, Toxicology

Role: Director of Toxicology leading nonclinical safety strategies for infectious disease and oncology programs, from candidate selection to clinical development and registration. Responsibilities: develop and execute toxicology plans, oversee GLP and non-GLP safety studies, review regulatory documents, interpret study data, and ensure compliance with global regulations; collaborate with cross-functional teams, including Regulatory, Clinical, and CMC. Requirements: PhD in Pharmacology, Toxicology, or Biomedical Sciences; DABT certification preferred; 12+ years industry experience with biologics, especially in oncology and infectious diseases; strong knowledge of GLP, FDA, EMA, ICH guidelines; proven track record in regulatory submissions and interactions. High-Value: biologics, infectious diseases, oncology, biologics development stages from candidate selection through clinical phases, regulatory filings (IND/BLA), emphasis on GLP compliance. WorkSetup: based in San Francisco with at least 3 days/week in-office; no travel specified.