Principal Scientist, Toxicologist/Study Director
Core
Lead and monitor nonclinical toxicity studies (GLP/non-GLP) for drug candidates, integrating data to characterize safety profiles and support regulatory submissions.
Role type
Principal Scientist, Toxicologist/Study Director
Builds
Nonclinical safety studies and regulatory strategies for drug development
Domain
Pharmaceutical/Biotech, Preclinical Toxicology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Study Directing, Study Monitoring, GLP Regulations, Toxicology, Immunology, Clinical Pathology, Report Preparation, Risk Identification, Regulatory Requirements, Cross-Functional Teamwork
Preferred skills
Biotherapeutics development, Outsourced study monitoring, Drug discovery team expertise, Regulatory agency interaction
Technologies
Immunoassays, Toxicokinetics
Responsibilities
Serve as single point of control for acute through chronic general toxicology studies; Critically analyze and interpret data from pathology, toxicokinetics, and other areas; Participate in cross-functional teams to investigate mechanisms of toxicity; Oversee strategy and design of nonclinical safety studies; Communicate results to global regulatory agencies; Mentor and develop staff.
Seniority
Principal, hands-on IC with strategic oversight