Study Director - Toxicology
People People
- Stilwell, KS
- Permanent
- Full-time
- Serve as the single point of control and accountability for assigned toxicology studies.
- Design and develop scientifically sound study protocols in collaboration with sponsors, proposal management, and internal scientific teams.
- Ensure studies are conducted in full compliance with regulatory requirements, internal SOPs, and GLP standards.
- Monitor the progress of studies, identify and resolve issues, and ensure adherence to timelines and deliverables.
- Interpret data and prepare high-quality study reports suitable for regulatory submissions.
- Collaborate closely with cross-functional teams, including laboratory scientists, pathologists, veterinarians, quality assurance personnel, and external sponsors.
- Participate in client meetings, audits, and regulatory inspections as needed.
- Maintain all study-related documentation and ensure appropriate archiving of records and materials.
- Drive process improvements and contribute to departmental and organizational initiatives
- Perform other duties as needed
- Bachelor's degree in toxicology, pharmacology, biology, or a related field required with 5+ years of experience in a non-clinical research environment.
- Advanced degree (M.S., Ph.D., D.V.M.) and experience preferred..
- Strong understanding of toxicology principles and regulatory guidelines (FDA, OECD, EPA, etc.).
- Exceptional organizational, analytical, and communication skills.
- Proficiency with electronic data systems and laboratory information management systems (LIMS) preferred
- Preferred Certifications:
- Certification by the American Board of Toxicology (DABT) or eligibility is a plus.