Nonclinical Toxicology Study Monitoring Scientist
Core
Provide scientific, technical, and operational oversight of outsourced nonclinical safety studies (toxicology) for small and large molecule modalities including cell and gene therapies.
Role type
Senior IC nonclinical toxicology study monitor
Builds
Nonclinical safety assessment data and study execution for drug development pipelines
Domain
Biopharmaceuticals / Nonclinical Safety / Toxicology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
in vivo laboratory experience, GLP compliance, protocol development and review, CRO management, issue escalation and resolution, regulatory document review, vendor qualification, digital/AI tool adoption
Preferred skills
prior sponsor-facing study monitoring experience, CRO oversight troubleshooting, multi-study coordination, regulatory submission support, vendor performance management
Technologies
digital tools, AI-enabled solutions, dashboards
Responsibilities
Develop and review protocols for nonclinical safety studies; conduct on-site and remote monitoring to assess data quality and GLP compliance; identify and resolve scientific or operational issues; prepare monitoring reports and visit summaries; manage action items and study milestones; support CRO qualification and audit activities; collaborate on regulatory submissions and health authority responses
Seniority
Senior, hands-on IC
