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Labcorp · 20 hours ago

Study Director - Toxicology

Greenfield, IN

Full-time

Onsite

Senior Level

Labcorp is recognized as one of the most respected companies in the world, focused on advancing science, technology, and innovation. The Study Director will serve as the scientific specialist for toxicology and crop protection studies, overseeing the technical conduct of studies and ensuring compliance with regulatory guidelines.

BiotechnologyHealth CareHospitalLife ScienceMedicalPrecision Medicine

No H1B

Responsibilities

Plan, design, and lead a team to conduct complex studies to generate high quality scientific results on behalf of Labcorp clients and play a key role in developing new strategies, techniques, and instrumentation for new ventures and critical issues around specialty

Develop protocols for assigned studies and ensure that the protocol, including any changes, is approved and in compliance with the appropriate SOPs, GLPs, and regulatory agency guidelines

Monitor financial status of ongoing assigned studies

Monitor progress and status of assigned studies. Ensure all experimental data, including observations of unanticipated responses to the test system, are accurately recorded and verified

Direct analysis of data, preparation of reports, ensure compliance with protocol and regulatory requirements, and submit them to the client

Coordinate effort of the study team, including external study team affiliates, as applicable

Initiate client contact for new business development

Lead and sponsor major client visits

Understand and consult with clients on regulatory issues and risk assessment considerations

Collaborate with client service, program management, and study direction to evaluate proposals around specialty, evaluate feasibility, and provide recommendations to clients

Facilitate or support client contact for new business development and assist in marketing and sales initiatives for the specialty toxicology program

Work with the Commercial Organization to develop new business lines and market them as needed

Peer review protocols and reports related to the specialty toxicology program, as well as other study types as necessary

Develop new technologies in area of expertise or enhance existing ones and assist in marketing new capabilities

Lead a scientific team to conduct complex and challenging feasibility/development studies

Provide a leadership role in troubleshooting and solving challenging technical problems

Assess client interest and technical feasibility of studies around specialty

Conduct special toxicology program review sessions with study teams and prepare presentations of toxicology information for other business units

Participate in and conduct scientific meetings and provide leadership in scientific organizations in the field of Toxicology

Author scientific papers, which are published in peer reviewed journals, and presented in scientific meetings

Lead scientific mentoring activities (e.g., training, study specific techniques, assisting with complex analytical work/problem solving, and presenting technique seminars)

Contribute to long-range planning and technical policies of the department

May be a Home Office Project License holder

Qualification

Toxicology expertiseStudy Director experienceRegulatory compliance knowledgeScientific presentationsScientific publicationsClient consultationTeam coordinationLeadership skillsProblem solvingMentoring

Required

Study Director experience; Toxicology and Crop protection and Chemical (CPC) preferred

Maintains current regulatory awareness (domestic and foreign), in the field of toxicology, with knowledge of current regulatory requirements for drug development and project management

Highly skilled in performing scientific presentations and preparing scientific publications

PhD in toxicology or related subject, DVM or equivalent degree. Relevant study director experience may be substituted for education