Eli Lilly and Company
Overview
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, with 39,000 employees worldwide who 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.
It is an exciting time to be 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 the management of nonclinical safety assessment study conduct, including the fundamentals of Good Laboratory Practices (GLP) and data interpretation of nonclinical toxicology studies. You will be the primary scientific, technical and procedural contact for studies conducted externally at third‑party organizations (TPOs). You will help enable toxicology studies by understanding the technical capabilities of individual TPOs and providing scientific input/expertise on whether studies can be performed as described in the protocol, especially those containing novel procedures. Responsibilities include establishing and adhering to non‑clinical study timelines, monitoring 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.
Responsibilities Study Implementation and Conduct:
Manage study achievements and metrics to ensure delivery to corporate milestones.
Serve as 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.
Study Design and Protocol Development:
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.
Data Review and Report Writing/Review:
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.
Business Plan Objectives:
Lead or collaborate both within department and cross‑functionally to accomplish objectives.
Qualifications Basic qualifications: Bachelor’s degree in Biology, Animal Sciences, Toxicology or a related field with 3 or more years of experience in a relevant industry setting.
Additional Skills and Preferences
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.
EEO and Disability Accommodations 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. Lilly is committed to helping individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If an individual requires a reasonable accommodation to participate in the application process, please email Lilly Recruiting Compliance.
Compensation and Benefits Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 – $169,400. Full‑time employees will also be eligible for a company bonus (depending in part on company and individual performance). Lilly offers a comprehensive benefits program to eligible employees, including eligibility to participate in a company‑sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits such as healthcare and/or dependent day‑care flexible spending accounts; life insurance and death benefits; certain time‑off and leave of absence benefits; and well‑being benefits such as employee assistance program, fitness benefits, and employee clubs and activities. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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It is an exciting time to be 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 the management of nonclinical safety assessment study conduct, including the fundamentals of Good Laboratory Practices (GLP) and data interpretation of nonclinical toxicology studies. You will be the primary scientific, technical and procedural contact for studies conducted externally at third‑party organizations (TPOs). You will help enable toxicology studies by understanding the technical capabilities of individual TPOs and providing scientific input/expertise on whether studies can be performed as described in the protocol, especially those containing novel procedures. Responsibilities include establishing and adhering to non‑clinical study timelines, monitoring 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.
Responsibilities Study Implementation and Conduct:
Manage study achievements and metrics to ensure delivery to corporate milestones.
Serve as 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.
Study Design and Protocol Development:
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.
Data Review and Report Writing/Review:
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.
Business Plan Objectives:
Lead or collaborate both within department and cross‑functionally to accomplish objectives.
Qualifications Basic qualifications: Bachelor’s degree in Biology, Animal Sciences, Toxicology or a related field with 3 or more years of experience in a relevant industry setting.
Additional Skills and Preferences
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.
EEO and Disability Accommodations 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. Lilly is committed to helping individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If an individual requires a reasonable accommodation to participate in the application process, please email Lilly Recruiting Compliance.
Compensation and Benefits Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 – $169,400. Full‑time employees will also be eligible for a company bonus (depending in part on company and individual performance). Lilly offers a comprehensive benefits program to eligible employees, including eligibility to participate in a company‑sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits such as healthcare and/or dependent day‑care flexible spending accounts; life insurance and death benefits; certain time‑off and leave of absence benefits; and well‑being benefits such as employee assistance program, fitness benefits, and employee clubs and activities. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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