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Lilly Advisor-Toxicology Project Leader 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.

Bring life-changing therapies to patients at Lilly, as we continue to expand our portfolio with groundbreaking modalities in areas such as genetic medicines, gene therapies, and gene editing. The Department of Nonclinical Safety Assessment within the Division of Toxicology/Pathology is searching for a Toxicology Project Leader to join our team. This is an opportunity to contribute to and make an impact in the drug development field. The successful candidate will provide scientific leadership and drug development expertise as well as represent Toxicology on drug development teams from early discovery through clinical trials to registration and beyond. This role plays an integral part in developing world-class medicines for Eli Lilly and Company.

This role will have leadership and advancement opportunity in the Division of Toxicology/Pathology which is a multidisciplinary group that uses basic and applied approaches to predict and evaluate the safety of new chemical and biological entities. This role integrates data from toxicological studies and provides an assessment of the potential physiologic/toxicologic outcomes that will guide clinical investigators.

Does this sound like a good fit? Join the Lilly team making life changing medicines for patients! Apply today and be a part of something special!

Responsibilities:

  • Toxicology representative on diverse scientific teams, working collaboratively across multiple functions including Chemistry, Discovery Biology, Drug Disposition, Pathology, Medical/Clinical, and Regulatory Affairs within Lilly and with external research organizations

  • Lead toxicology strategy, and design effective toxicology plans to identify issues, characterize, and address risk of toxicity for compounds moving through development.

  • High level of impact both internally within Lilly and in the external research and/or regulatory environment.

  • Contribute to a group of highly engaged scientists, providing industry-leading toxicology support to development teams.

Basic Requirements:

PhD in Toxicology or a related field with 2+ years of relevant experience or MS degree with at least 7 years of applicable experience post education or training

Additional Preferences:

  • Expertise with development of novel modalities, experience with genetic medicine, RNA/DNA-based therapeutics, gene therapy, gene editing highly preferred

  • Experience developing and coordinating nonclinical development strategies for various stages of pharmaceutical development; preparing a nonclinical safety assessment for clinicians and regulatory agencies.

  • Knowledge of global regulatory guidance (e.g. ICH and geography-specific guidance's) and Good Laboratory Practice (GLP) standards

  • Diplomate, American Board of Toxicology (DABT)

  • Strong verbal and written communication skills

  • Ability to work effectively in a team environment

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

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