Lilly Associate Consultant-Toxicology in Indianapolis, Indiana
The Nonclinical Study Management Team (NSMT) Team is looking to fill a position that requires expertise in nonclinical safety assessment study conduct, including the fundamentals of Good Laboratory Practices (GLP), and data interpretation of nonclinical studies. Do you possess a current understanding of trends of nonclinical safety assessment in the TPO landscape? Do you possess a deep understanding of scientific principles and design of scientific studies? You will support nonclinical submissions of Lilly Investigational New Drug (IND) applications, marketing applications such as New Drug Applications and Biologics License Applications, and other strategic submissions including regulatory responses. Are you familiar with the purpose, components, and outcomes of drug development, safety assessment, and have experience managing and tracking document completion? We need you on our team.
You will be the primary scientific, technical and procedural contact for studies conducted externally at third party organizations (TPOs). To enable toxicology studies, it is critical that you 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. As you manage these relationships and protocols your responsibilities will 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 the course of study planning, execution and reporting.
Additionally, you will serve as the Subject Matter Expert for nonclinical electronic Common Technical Document (eCTD) content, as well as for nonclinical document and submission publishing. This role involves coordination with ATP scientists, Discovery biologists, and Environmental Risk Assessment scientists. You will establish and adhere to submission timelines and track progress including document publishing, approval and transition to the regulatory submission publishing team. You will review, format, and edit, documents as appropriate.
You are a catalyst who supports drug development and safety assessment, liaises with Third Party Organizations, and is the nonclinical submission coordinator and regulatory associate.
In this role you will be responsible for:
Work with Toxicology Project Leaders 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:
Manage study achievements and metrics to ensure delivery to corporate milestones.
You will be the primary Lilly representative that visits TPOs during the course of the study to ensure technical capabilities are adequate and procedures match the protocol.
Collaborate with TPOs as the first line of contact for any study-related issues. Make the initial determination of the impact of the issue on study integrity.
Report Writing and Review:
Serve as the first point within Lilly for the receipt, review and interpretation of study data.
Organize 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 accomplish objectives developed to benefit the group
Nonclinical Submission Coordinator and Regulatory Associate
Establishing appropriate regulatory strategy and resolving submission deliverables, in collaboration with the regulatory and nonclinical (Toxicology, ADME, Discovery Biology, and Environmental Risk Assessment) scientists
Establishing and managing submission timelines, and tracking submission components
Experience in animal husbandry
Excellent communication skills (written and oral)
Attention to detail and ability to multitask
Strong teamwork skills with internal and external partners
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)
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Non-Clinical Study Monitor
Bachelor’s degree in Toxicology or related discipline
Experience in the pharmaceutical or CRO related industry preferred
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
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.
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