The Senior Director of Toxicology will be responsible for building the overall toxicology strategy and targeted toxicology packages to support regulatory submissions for small molecule drug discovery programs from IND to NDA. The successful candidate will have substantial experience in CNS drug development and the ability to contribute effectively to cross-functional drug development teams. They will manage CROs to conduct regulatory-compliant toxicology studies and lead the outsourcing efforts for the design, monitoring, execution, and reporting of all nonclinical toxicology studies. As the nonclinical Safety Assessment lead for multiple programs, they will evaluate and author responses to inquiries from health authorities.
Requirements
• Ph.D. in Toxicology, Pharmacology, Biology, or related discipline with 10+ years of pharmaceutical industry experience in neuroscience drug development toxicology
• Strong knowledge of FDA, EMA, and ICH guidance documents and GLP regulations
• Deep understanding of QA, regulatory, and clinical functions for nonclinical safety assessment activities
• Experience serving as the Safety Assessment lead in cross-functional drug development teams
• Experience in authoring non-clinical elements of major regulatory submissions and responding to regulatory inquiries
• Successful outsourcing and monitoring of toxicology studies with CROs
• Previous interaction with FDA Psychiatry and Neurology divisions is highly desirable
• Detail-oriented, able to function well in a hands-on environment
• Excellent verbal communication and scientific writing skills for study reports and regulatory documents
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