Sr. Research Scientist, Non-Clinical Safety & Toxicology

Role Summary

Senior Research Scientist, Non-Clinical Safety & Toxicology leads human (user & consumer) safety and target animal safety strategy and execution across the full product lifecycle for global veterinary drug/product and feed additive development, as well as safety assessments for marketed products. The role applies toxicology and immunology expertise to evaluate safety risks, prepare Product Safety Assessments (PSAs), and compile data to assess potential health risks for end users. Collaboration with cross-functional teams and regulatory engagement are essential to advance projects from early development through commercialization.

Responsibilities

• Independently design, organize, monitor, report, and resolve issues related to outsourced in vitro and in vivo safety/toxicology studies, utilizing external CROs and/or consultants as needed. These studies may involve rodent and non-rodent species; target animal safety evaluations may include companion and food-producing animals.
• Conduct literature reviews and author expert reports, position papers, safety and hazard/risk assessments, and other evaluations to address safety considerations for veterinary drugs, feed additives, excipients, E&L substances, impurities, or other chemicals.
• Provide internal expert guidance, including statements, health-based exposure limits (e.g., PDEs, OELs), and target safety assessments.
• Engage with regulatory agencies to address safety concerns for products in development and marketed products, including preparing and submitting documentation and delivering formal presentations.
• Collaborate with Manufacturing, Quality, Human Food Safety, ADME/PK, and Environmental Safety to accomplish multidisciplinary non-clinical objectives.
• Participate in global, cross-functional project teams within a matrix organization to drive project success.
• Maintain technical and professional expertise by staying current with scientific developments and sharing insights and best practices within the organization.

Qualifications

• Required: Education: DVM and/or PhD (preferred) in toxicology or another relevant biomedical science with at least 5 years of industry experience in non-clinical safety, or Master’s with at least 7 years of relevant experience.
• Required: Demonstrated ability to apply toxicology and risk assessment principles aligned with global regulations and guidance; experience in non-clinical veterinary drug development, target safety assessments, in silico predictions, and safety evaluations throughout product life cycles; strong background in biologics, vaccines, and antibody development; ability to use in vitro/in vivo data and literature to support development and registration.
• Required: Strong collaborative, cross-functional, regulatory strategy, and communication skills; expertise in toxicology and immunology with risk assessment capabilities.
• Preferred: Board certification as a toxicologist (ERT, DABT, or equivalent).
• Preferred: Immunological background related to monoclonal antibodies and platform technologies for dermatology or pain; deep understanding of veterinary drug development and agribusiness practices; GLP knowledge and in silico toxicity tools.
• Preferred: Ability to manage complex projects independently with strong organizational and time management skills; excellent written and verbal English communication.

Skills

• toxicology and immunology expertise with risk assessment
• cross-functional collaboration and regulatory strategy
• effective communication of complex scientific concepts

Education

• DVM and/or PhD in toxicology or related biomedical science (preferred)
• Alternatively, Master’s degree with substantial relevant experience

Additional Requirements

• Travel: Up to 30% annually (domestic and international)
• Location: Global Elanco Headquarters - Greenfield, IN - Hybrid Work Environment (Soon to be Indianapolis, Indiana NEW HQ October 2025)