Sr. Research Scientist, Non-Clinical Safety & Toxicology

Role Summary

Senior Research Scientist, Non-Clinical Safety & Toxicology — Sr. Research Scientist, Non-Clinical Safety & Toxicology role within Global Non-Clinical Development. Responsible for human (user & consumer) safety and target animal safety program strategy and execution across global veterinary drug/product and feed additive R&D, product safety assessments, and support for marketed products. Applies toxicology and immunology to assess safety risks across the product lifecycle and prepares Product Safety Assessments (PSAs).

Responsibilities

• Independently design, organize, monitor, report, and resolve issues related to outsourced in vitro and in vivo safety/toxicology studies, using external CROs and/or consultants as needed. Studies may involve rodent and non-rodent species; target animal safety evaluations may include dogs, cats, and food-producing animals.
• Conduct literature reviews and author expert reports, safety/hazard/risk assessments, and other strategic scientific evaluations to address safety considerations for veterinary drugs (small molecules and biologics), feed additives, excipients, E&L substances, impurities, or other chemicals.
• Provide internal expert guidance, including 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 for projects and products.
• Proactively 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 relevant insights and best practices within the organization.

Qualifications

• Education: DVM and/or PhD (preferred) in toxicology or another relevant biomedical science (e.g., veterinary medicine, biology, chemistry) with at least 5 years of industry experience in non-clinical safety, or Master’s degree with at least 7 years of relevant experience.
• Experience: Demonstrated ability to apply toxicology and risk assessment principles per global regulations. Experience in non-clinical veterinary drug development, target safety assessments, in silico predictions, and safety evaluations across product life cycles. Strong background in large molecules, biologics, vaccines, and antibody development; proficient in using in vitro/in vivo data and literature to support product development and registration.
• Top 2 skills: Collaborative team-player with toxicology and immunology expertise, strong risk assessment capabilities; cross-functional collaboration, regulatory strategy, and clear communication of complex scientific concepts.

Skills

• Toxicology and immunology expertise
• Risk assessment and regulatory strategy
• Cross-functional collaboration
• Scientific writing and presentations

Education

• DVM and/or PhD in toxicology or related biomedical field (preferred)

Additional Requirements

• Travel: Up to 30% annually (domestic and international)
• Location: Global Elanco Headquarters - Greenfield, IN - Hybrid Work Environment (Relocation and HQ update planned)