Lilly Developmental and Reproductive Toxicology Study Manager in Indianapolis, Indiana
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 35,000 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 Developmental and Reproductive Toxicology study monitor with expertise in management of DART study conduct and data interpretation. We need someone who understands the fundamentals of Good Laboratory Practices (GLP), the purpose, components, and outcomes of successful drug development. If this sounds like you, apply today and join our team dedicated to improving the lives of patients worldwide!
You will be the primary scientific, technical and procedural contact for studies conducted externally at third party organizations (TPOs). To enable DART 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.
Study Design and Protocol Development:
Partner with Toxicology Project Leaders and project teams to establish DART strategy for projects.
Develop 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.
Study Implementation and Conduct:
Manage study achievements and metrics to ensure delivery to corporate milestones.
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.
Report Writing and Review:
Integrate and assemble Toxicology information for IND/CTD and IB documents
Serve 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
Business Plan Objectives:
- 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 2 or more years of experience in relevant setting
Experience in animal husbandry
Experience in multiple DART study types.
Experience in juvenile studies.
Experience with NHPs
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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At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!