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    Senior Toxicology Project Lead

    Eli Lily
    10+ years
    Not Disclosed
    Indianapolis
    10 Jan. 30, 2025
    Job Description
    Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Senior Toxicology Project Lead

    Location: Indianapolis, Indiana, United States
    Category: Research & Development
    Job Type: Full-Time, Regular
    Job ID: R-69951

    Company Overview:

    At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader, headquartered in Indianapolis, Indiana, our employees work to discover and deliver life-changing medicines to those in need. We focus on improving the understanding and management of diseases and give back to communities through philanthropy and volunteerism. We value a culture of inclusion and collaboration and encourage people determined to make life better for patients globally to join us.

    Position Summary:

    The Nonclinical Safety Assessment group is seeking a Senior Toxicology Project Lead to provide scientific leadership and drug development expertise. In this role, you will be the toxicology representative on drug development teams, contributing to projects from early discovery to clinical trials and beyond. This position plays a crucial role in developing safe, effective medicines and offers leadership and advancement opportunities within the Division of Toxicology/Pathology, a multidisciplinary group dedicated to assessing the safety of novel drug candidates.

    Responsibilities:

    • Act as the toxicology representative on scientific teams, collaborating with Chemistry, Discovery Biology, Drug Disposition, Pathology, Medical/Clinical, and Regulatory Affairs teams, both internally at Lilly and externally with research organizations.
    • Lead toxicology strategy and design toxicology plans to identify, characterize, and address potential toxicity risks for drug candidates through development.
    • Contribute to industry-leading toxicology support for development teams and collaborate with external research partners.
    • Ensure compliance with global regulatory guidance (e.g., ICH, GLP standards) for nonclinical safety assessments and clinical/registration submissions.
    • Develop and coordinate nonclinical development strategies for various stages of pharmaceutical development.
    • Prepare nonclinical safety assessments to inform clinicians and regulatory agencies on the safety of drug candidates.
    • Represent Lilly in the external research and regulatory environments, driving the company’s toxicology initiatives and strategies.

    Basic Qualifications:

    • PhD in Toxicology or a related field with 5+ years of relevant experience, or an MS degree with at least 10 years of applicable experience in toxicology.
    • Strong verbal and written communication skills.
    • Ability to work effectively in a collaborative, team-oriented environment.

    Additional Skills/Preferences:

    • Experience developing and coordinating nonclinical development strategies for pharmaceutical products and preparing nonclinical safety assessments.
    • Knowledge of global regulatory guidance such as ICH guidelines, and geographic-specific regulations, and Good Laboratory Practice (GLP) standards.
    • Diplomate, American Board of Toxicology (DABT) certification is preferred.
    • Experience with novel modalities in drug development, such as biologics, gene therapies, or other advanced therapeutics, is highly valued.
    • Strong leadership skills and the ability to make decisions that impact drug development processes and safety assessments.

    Work Location:

    This position will be based at the Lilly Corporate Center in Indianapolis, IN.

    Lilly’s Commitment to Diversity:

    Lilly is committed to providing equal opportunities in the workplace and ensures that individuals with disabilities can fully participate in the hiring process. If you require accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources at Lilly_Recruiting_Compliance@lists.lilly.com for assistance.

    Equal Opportunity Employer:

    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.

     

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    Bucharest :

    Bucharest |

    Makkah :

    Jeddah | King Abdullah Economic City | Khulais | Riyadh | Najran | Rabigh |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    South Africa | Midrand |

    Brazil :

    Brazil | Sao paulo |

    South America :

    Argentina | Peru |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |