Principal Scientist, Toxicology

Role: Principal Scientist, Toxicology, leading design and oversight of nonclinical safety studies for development candidates. Responsibilities include developing protocols, monitoring studies, preparing regulatory toxicology documentation (e.g., IND sections, IBs), and ensuring compliance with GLP and regulatory standards. The role involves cross-functional collaboration with project teams, external CROs, and regulatory authorities. Requirements: Ph.D. in Toxicology or related field with at least 7 years of industry experience; hands-on experience with nonclinical safety studies, GLP compliance, and regulatory document writing; proficiency in Microsoft Office; strong communication, problem-solving, and project management skills. Preferred: Diplomate of the American Board of Toxicology (DABT) and experience with orphan diseases. High-value: focus on nonclinical safety in biopharma, supporting early to advanced development stages, with global regulatory engagement. Work setup involves 10-25% travel.