Study Director - Toxicology

Overview

At Labcorp, we advance science, technology and innovation and are recognized as one of the most respected companies in the world. Our team is driven by an energizing purpose to improve health and improve lives. Here, you can play a role in bringing new scientific discoveries to life and make a difference in the lives of millions. Join us and discover your extraordinary potential.

We have an excellent career opportunity for an experienced Study Director – Toxicology and Crop Protection and Chemical studies to join our dynamic team in Greenfield, IN
.

Relocation assistance available.

This position is not eligible for visa sponsorship.

The Study Director serves as the scientific specialist for toxicology and crop protection and chemical studies, with overall responsibility for the technical conduct of a study as well as for the interpretation, analysis, documentation, and reporting of results in compliance with applicable SOPs, GLPs, Home Office License requirements and regulatory agency guidelines.

• 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.

• 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.

• Diplomate, ABT certification desirable.

• Recognized…