Nonclinical Toxicology Study Monitoring Scientist
Core
Provide scientific, technical, and operational oversight of outsourced nonclinical toxicology and safety studies for small and large molecule modalities including cell and gene therapies.
Role type
Senior IC nonclinical toxicology study monitor
Builds
Nonclinical safety assessment studies for drug development pipelines
Domain
Life sciences / Nonclinical safety / Toxicology
Required skills
in vivo laboratory experience, GLP regulations knowledge, CRO management, multi-study coordination, risk identification, scientific problem-solving, regulatory document review, digital/AI tool adoption
Preferred skills
prior sponsor-facing study monitoring experience, CRO audit support, vendor qualification, AI-enabled workflow optimization
Technologies
Digital tools, AI-based solutions, dashboards
Responsibilities
Develop and review protocols for nonclinical safety studies, conduct on-site and remote study monitoring at CROs, identify and resolve study execution issues, prepare monitoring reports and visit summaries, manage action items and study milestones, support CRO qualification and audit activities, collaborate on regulatory submissions
Seniority
Mid-Senior, hands-on IC