Scientist, Nonclinical Safety and Pathobiology
Core
Lead outsourced GLP and non-GLP nonclinical safety studies from planning through final report, ensuring inspection-ready outputs for regulatory submissions.
Role type
Senior IC nonclinical safety study monitor
Builds
Regulatory submission packages (INDs, NDAs, BLAs) and study reports
Domain
Biopharmaceutical nonclinical safety and toxicology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GLP study conduct, toxicology principles, CRO management, regulatory compliance (FDA/ICH/EMA), study design, pathology workflows, risk identification, scientific literature review
Preferred skills
Multi-study type monitoring experience, toxicokinetics knowledge, animal welfare standards (USDA/AAALAC), SEND dataset review, study tracking systems
Technologies
Microsoft Office suite, electronic QC workflows, SEND tools
Responsibilities
Independently monitor and coordinate outsourced nonclinical safety studies; Lead multi-study projects and cross-functional meetings; Review protocols, data, and reports for scientific accuracy and compliance; Perform independent QC review of regulatory documents; Conduct CRO site selection and monitoring visits; Support process improvement and mentoring initiatives
Seniority
Senior, hands-on IC
