Scientist, Nonclinical Safety and Pathobiology

Role: Nonclinical Study Monitor leading outsourced GLP and non-GLP safety studies supporting discovery and regulatory development programs. Responsibilities: independently oversee study planning, CRO coordination, data review, report writing, and regulatory document support; lead cross-functional study meetings; perform QC reviews; identify risks and ensure timely, compliant study execution; participate in vendor oversight and process improvements. Requirements: Bachelor's degree with six years or master's with four years of relevant toxicology or pharmacology experience; expertise in GLP-regulated nonclinical safety studies; strong knowledge of toxicology principles, animal welfare standards, and regulatory guidelines (FDA, ICH, OECD); excellent communication, organizational, and stakeholder management skills; proficiency with study tracking and documentation tools. Preferred: experience across multiple modalities, species, and therapeutic areas; active involvement in professional organizations. HighValue: nonclinical safety, GLP studies, IND-enabling projects, regulatory support, CRO management, toxicology expertise, biologics/pharmaceuticals, preclinical to early clinical phases. WorkSetup: typically less than 15% travel.