Study Manager, Toxicology

Role: Preclinical Study Manager overseeing non-GLP and GLP toxicology studies from research to late-phase development, ensuring regulatory compliance and scientific objectives. Responsibilities: coordinate with CROs and internal teams to design, monitor, and review toxicology studies; facilitate data analysis and regulatory submissions; manage vendor relations, contracts, and SOP development; support study reports and audits. Requirements: BS in science; 5+ years in biotech/pharma/CRO industries; strong knowledge of GLP, ICH, FDA guidelines; excellent cross-functional communication, negotiation, and project management skills. High-Value: toxicology study management, CRO collaboration, regulatory documentation, late-stage nonclinical development, international compliance, and study oversight in oncology. WorkSetup: onsite Redwood City, CA; travel as needed.