Principal Scientist, Toxicology

Job Description Job Description Principal Scientist, Preclinical Toxicology Location: San Diego, CA | Full-time Summary We are seeking a senior-level toxicologist to lead and oversee GLP-compliant preclinical toxicology programs supporting IND, NDA, and BLA submissions. This role is ideal for a highly experienced Study Director with strong regulatory expertise and the ability to balance CRO service delivery with sponsor-driven drug development goals. Responsibilities Serve as Study Director for GLP in vivo and in vitro toxicology studies Design, oversee, and interpret toxicology studies aligned with FDA, ICH, and international regulatory expectations Act as the primary scientific and client-facing lead for preclinical toxicology programs Integrate toxicology, pathology, and clinical pathology data into defensible regulatory conclusions Author, review, and approve final study reports and nonclinical regulatory content Support IND, NDA, and BLA submissions and participate in FDA-facing interactions as needed Ensure GLP compliance and represent the organization during audits and inspections Coordinate cross-functionally to ensure timelines, data integrity, and scientific rigor Qualifications PhD in Toxicology, Pharmacology, or related discipline 5–7+ years of experience directing GLP toxicology studies, preferably in a CRO environment Proven track record as Study Director on completed GLP studies supporting regulatory submissions Direct experience contributing to IND/NDA/BLA nonclinical packages Strong understanding of FDA expectations and regulatory strategy DABT certification strongly preferred Why Join Senior scientific leadership role with high impact on drug development programs Opportunity to guide complex preclinical toxicology strategies Collaborative, science-driven environment supporting innovative therapeutics