Sr. Toxicologist - Study Monitor - Eli Lilly and Company

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

It is an exciting time to be a part of Team Lilly! Do you have experience working in a GLP environment designing and supervising the conduct of toxicology studies? The Nonclinical Study Management Team (NSMT) is a hardworking and diverse team looking for an experienced Toxicology study monitor with expertise in management of nonclinical safety assessment study conduct, including the fundamentals of Good Laboratory Practices (GLP) and data interpretation of nonclinical toxicology studies. We need someone who understands the purpose, components, and outcomes of successful drug development and safety assessment. You will be the primary scientific, technical and procedural contact for studies conducted externally at third party organizations (TPOs). To enable toxicology studies, study managers must understand the technical capabilities of individual TPOs and provide scientific input/expertise on whether studies can be performed as described in the protocol, especially those containing novel procedures.

Responsibilities include establishment of, and adherence to, non-clinical study timelines, monitoring of study conduct at the TPO via communication with the Study Director and/or onsite observation, and real time communication with the Toxicology ADME/ToxPath/Drug Disposition (ATP) team throughout study planning, execution and reporting.

Do you have in vivo experience along with study monitor skills? If so, apply today to join the Lilly team!

Study Implementation and Conduct:

• Manage study achievements and metrics to ensure delivery to corporate check points.
• The primary Lilly representative that visits TPOs during the course of the study to ensure technical capabilities are adequate and procedures match the protocol.
• Interact with TPOs as the first line of contact for any study-related issues. Make the initial determination of the impact of the issue on the integrity of the study.

• Partner with Toxicology Project Leaders and other scientists to develop study designs and detailed study protocols, including an assessment of the technical ability of the TPO to meet the scientific requirements of the protocol.
• Resolve any concerns with TPOs regarding specific components of study protocols; whether scientific or logistical.
• Ensure the protocol meets GLP expectations and protocol-related documentation is available to the TPO prior to study start.

• Integrate and assemble Toxicology information for IND/CTD and IB documents
• Serve as point person within Lilly for the receipt, review and interpretation of study data.
• Coordinate and monitor the internal review of study data to assure compliance with study timelines.
• Compile all report comments and assure they are conveyed to the Study Director at the TPO

• Lead or collaborate both within department and cross-functionally to accomplish objectives

• Bachelor’s degree in Biology, Animal Sciences, Toxicology or a related field with 3 or more years of experience in relevant industry setting

• Experience in animal husbandry/in vivo study conduct within Toxicology
• Project management experience
• Excellent communication skills (written and oral)
• Attention to detail and ability to multitask
• Good understanding of scientific principles and design of scientific studies
• Strong teamwork skills with internal and external partners
• Current understanding of trends of nonclinical safety assessment in the TPO landscape
• Understanding of Regulatory policies and procedures pertaining to GLP study design and reporting

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