The Study Director - Toxicology is responsible for the overall conduct, scientific integrity, and regulatory compliance of nonclinical research studies-both regulated and nonregulated. This role involves the design, planning, execution, interpretation, and reporting of a wide range of toxicology studies supporting drug development, chemical safety, and product safety assessments.
What you will be doing?- 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
The Requirements of the Position- 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.
Preferred Certifications:- Certification by the American Board of Toxicology (DABT) or eligibility is a plus.
- GLP training or certification.
Physical Demands:- Communication and Computer Use: Regularly required to speak and hear in order to communicate effectively with colleagues and external partners. Frequent use of a computer, including typing, data entry, and extended periods of screen time.
- Vision: Specific visual abilities include close vision, color vision as applicable to research activities, and the ability to adjust focus.
- Lifting and Moving: When working with animals or equipment, the employee must be able to:
- Independently lift and carry up to 50 pounds.
- Push or pull wheeled cages, racks, or pallets weighing between 700 and 1,600 pounds (equipment and/or animals). Assistance and proper equipment are provided as needed.
- Mobility: Ability to stand and walk for extended periods of time in animal facilities, laboratories, and office environments.
- Posture and Movement: Frequent bending, stooping, reaching, and crouching may be required during animal handling, equipment set-up, and study-related activities.
- Repetitive Motion: Frequent repetitive movements of the hands, wrists, arms, and shoulders, including pipetting, typing, animal handling, and cage/equipment manipulation.
Join the Attentive Science team and grow your career with us while contributing to the discovery and development of life saving remedies. Attentive Science provides a comprehensive benefits package including Healthcare, Dental, Vision, 401k, Tuition Reimbursement and on-the-job career development.
