Study Director / Technical Assistant - Non-clinical Toxicity studies
Core
Lead non-clinical toxicity studies ensuring GLP compliance, administering test items, and managing data/reporting for regulatory submissions.
Role type
Senior IC study director / technical assistant (non-clinical toxicology)
Builds
GLP-compliant non-clinical toxicity study reports and regulatory documentation
Domain
Life sciences / Non-clinical toxicology
Required skills
GLP study design and execution, test item administration, data review and deviation identification, regulatory reporting, cross-functional coordination, stakeholder management, scientific problem-solving, regulatory framework knowledge
Preferred skills
Leadership and mentoring, critical thinking, time management
Technologies
GLP, OECD, ICH, FDA, EPA guidelines
Responsibilities
Lead study execution including planning, conduct, oversight, and reporting; Administer test items via multiple routes of exposure; Review study data for deviations; Prepare high-quality study reports and responses to sponsor inquiries; Coordinate with pathology, analytical, bioanalytical, veterinary, and QA teams; Support regulatory submission activities
Seniority
Senior, hands-on IC
