Remote Study Director

The Study director supervises and leads the conduct of regulatory studies within a contract research laboratory environment, focusing on toxicology and related scientific disciplines. This role combines hands-on scientific work with oversight of study design, implementation, data interpretation, and reporting, while ensuring strict adherence to GLP, EPA, FDA, DOT, OECD, ISO and other relevant regulatory standards. The Study director serves as a key technical expert, study director, and primary liaison with sponsors, contributing to studies that support the development of therapies, including work with animal models to help advance cancer research.

• Supervise the conduct of regulatory studies, providing day-to-day direction and oversight of all phases of study execution.
• Assist in the development, design, and implementation of study protocols, ensuring scientific rigor and regulatory compliance.
• Establish test protocols and corresponding standard operating procedures (SOPs) for studies under your responsibility.
• Develop experimental designs and supervise the implementation of experiments and tests, including hands-on participation as needed.
• Obtain sponsor approval for study protocols and institute any necessary deviations from the test protocol with appropriate sponsor authorization.
• Ensure that all experimental data and observations, including unanticipated responses of the test system, are accurately recorded, verified, and documented.
• Ensure that tests are conducted in accordance with approved protocols, SOPs, GLP regulations, and relevant regulatory guidelines (EPA, FDA, DOT, OECD, ISO).
• Interpret, analyze, document, and report study results, preparing clear and comprehensive technical reports for sponsors and internal stakeholders.
• Act as a primary liaison with clients, maintaining professional communication, managing expectations, and responding to study-related inquiries.
• Oversee overall day-to-day laboratory operations related to assigned studies, including supervision and leadership of technical staff.
• Schedule and coordinate the initiation and conduct of studies, adapting to changing timelines and client-driven priorities in a fast-paced environment.
• Track study schedules and financial aspects of assigned studies on a regular basis, ensuring accurate monitoring of timelines and resources.
• Lead and mentor less experienced personnel, providing guidance on laboratory techniques, study procedures, and regulatory requirements.
• Run and oversee assays, including gene toxicity assays and other laboratory tests, ensuring high-quality, reliable results.
• Review weekly study schedules to determine required activities, ensuring all tasks align with protocol requirements and timelines.
• Check study protocols prior to execution to confirm procedures, dosing regimens, and data collection requirements.
• Conduct dosing studies in the vivarium, including measuring body weights of animals and administering test articles via single injection or other specified routes.
• Perform animal handling procedures, including wrapping and restraint as needed, while monitoring and documenting observations after dosing.
• Report study progress, summarize testing activities, and contribute to assay-related documentation and study reports.
• Support device-related testing activities as needed, including device preparation for testing, disassembly, extractions, and preparation of materials in accordance with ISO practices.
• Maintain good administrative practices, documentation accuracy, and compliance with all applicable quality and regulatory standards.

• Bachelor of Science degree or equivalent experience in a relevant field such as toxicology, animal science, chemistry, biology, or microbiology.
• Hands-on working knowledge of the tests and assays under study responsibility, including cell culture, aseptic technique, and laboratory assays.
• Intimate working familiarity or the ability to quickly learn and develop familiarity with government regulations related to testing, particularly EPA, FDA, DOT, OECD, GLP regulations, and ISO standards.
• Demonstrated experience in GLP-regulated contract research organization (CRO) environments.
• Direct experience with mouse lymphoma assays.
• Direct experience with gene toxicity assays, including in vitro micronucleus (IVMN) assays.
• Experience working under OECD Guideline 490 for in vitro mammalian cell gene mutation tests.
• Strong administrative skills and leadership ability,…