Associate Principal Scientist, Toxicology/Study Director
Core
Conduct and monitor GLP and non-GLP in vivo toxicology studies as a Study Director or Study Monitor to characterize the safety profile of drug candidates from early discovery to late development.
Role type
Senior IC toxicologist (Study Director)
Builds
In vivo toxicity studies and regulatory safety reports
Domain
Pharmaceutical nonclinical drug safety
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
General toxicology, GLP compliance, Study Directing, Study Monitoring, data integration, regulatory submissions
Preferred skills
Biologics and small molecule therapeutics experience, outsourced study monitoring, ICH safety guidelines
Technologies
GLP, FDA 21 CFR Part 58, ICH guidelines
Responsibilities
Serve as single point of control for acute through chronic general toxicology studies; critically analyze and interpret data from clinical pathology, pathology, and toxicokinetics; ensure regulatory rigor and proactive risk identification; lead method development and inter-group initiatives.
Seniority
Senior, hands-on IC
