Lilly Nonclinical Study Management-Toxicology 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 39,000 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! Lilly research is stronger than ever. We are adding to our dynamic group of employees in the Nonclinical Study Management Team (NSMT). We are a hardworking team looking for a Toxicology study manager with expertise in management of nonclinical document submissions and safety assessment study conduct. Do you have experience working in a GLP environment, leading regulatory document submissions, and crafting and supervising the conduct of toxicology studies and interpreting data of nonclinical studies? We are looking for someone who understands the purpose, components, and outcomes of successful drug development and safety assessment. This role collaborates with various scientists to maintain nonclinical documents and submit to regulatory authorities. On our team you will be the primary scientific, technical, and procedural contact for studies conducted externally at third party organizations (TPOs). Key responsibilities of this role will be:
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.
Establish, enable, and manage the entire submission process, ranging from timeline management and adherence to regulatory authority guidelines to editing documents and publishing for submission.
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.
Additional Job Details
Nonclinical Document Submission (first year focus):
Serve as the Subject Matter Expert for the nonclinical document and submissions planning as well as the nonclinical electronic Common Technical Document (eCTD) content.
Coordinate timelines and submission activities with a variety of scientists, discovery biologists, and environmental risk assessment scientists.
Ensure adherence to company and regulatory guidelines for document submissions.
Manage and track progress of submission timelines and assist with regulatory responses.
Review, format, edit and publish documents.
Work with Toxicology Project Leaders (TPL) to 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:
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, assessing impact of issue on study integrity.
Review study data as they become available and share preliminary interpretations.
Manage study landmarks and metrics to ensure delivery to corporate milestones.
Report Writing and Review:
Integrate and assemble Toxicology information for IND/CTD and IB documents
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 with inter- and intra-department colleagues to attain objectives developed to benefit the group
- Bachelor’s degree in Biology, Animal Sciences, Toxicology or a related field with two or more years of experience in relevant industry setting
Additional Skills and Preferences
Experience in animal husbandry
Excellent written and oral communication skills with expertise in Microsoft Office Suite
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
Working Area: Mainly office area while at Lilly; however, will need to enter animal rooms at TPOs to observe animals, procedures, or necropsies
Work hours: Normal daytime hours; some travel to TPOs required (may require weekend travel)
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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!