(StealthCo) Director/Senior Director: Toxicology
About the role:
A stealth mode biotech company is seeking a highly motivated Director / Senior Director to lead toxicology activities supporting the development of novel therapeutics. The successful candidate will play a key role in developing and executing the nonclinical toxicology strategy, including non-GLP NHP studies, GLP toxicology studies, and IND-enabling activities. This individual will work closely with internal teams and external CROs to design, execute, interpret, and report toxicology studies and will contribute to preparation of regulatory submissions. The position is a rare opportunity to play a pivotal role in the successful development of new drugs for patients within an early-stage therapeutics company backed by highly regarded investors.
Key Responsibilities:
- Lead development and execution of nonclinical toxicology strategies supporting candidate selection, GLP toxicology, IND-enabling activities, and first-in-human studies
- Design and oversee non-GLP and GLP toxicology studies, including dose range-finding, repeat-dose, recovery, and other studies as appropriate for the development program
- Partner with internal teams and external CROs to develop study designs, protocols, dosing strategies, endpoints, timelines, and data analysis plans
- Serve a