Sr. Research Scientist, Non-Clinical Safety & Toxicology

Role Summary

Senior Research Scientist, Non-Clinical Safety & Toxicology – You will be responsible for, or will assist with, human (user & consumer) safety and target animal safety program strategy and execution at all phases of global veterinary pharmaceutical drug/product and feed additive research and development, product safety assessments, and support for marketed products.

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 typical rodent and non-rodent species. Target animal safety evaluations may include companion animals (dogs and cats) as well as food-producing animals (e.g., cattle, pigs, chickens).
• Conduct literature reviews and author expert reports, position papers, safety and hazard/risk assessments, and other strategic scientific, technical, or medical 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 expert statements, health-based exposure limits (e.g., PDEs, OELs), and target safety assessments.
• Engage with regulatory agencies to address safety concerns for both products in development and marketed products, including preparing and submitting documentation and delivering formal presentations.
• Collaborate closely with colleagues in 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 (e.g., clinical, pharmaceutical development, regulatory affairs, quality, manufacturing) 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 discipline (e.g., veterinary medicine, biology, chemistry) with at least 5 years of industry experience in non-clinical safety, or a Master‚Äôs degree with at least 7 years of relevant experience.
• Experience: Demonstrated ability to apply toxicology and risk assessment principles aligned with global regulations and guidance. Experience in non-clinical veterinary drug development, including target safety assessments, in silico predictions, and safety evaluations throughout product life cycles. Strong background in large molecule, biologics, vaccine, and antibody development, as well as using in vitro/in vivo data and literature to support product development and registration.
• Top 2 skills: A strong, collaborative team-player with expertise in toxicology and immunology with strong risk assessment capabilities. Highly skilled in cross-functional collaboration, regulatory strategy, and effective communication of complex scientific concepts.

Skills

• Cross-functional collaboration
• Toxicology and immunology expertise
• Regulatory strategy and communication of scientific concepts
• Risk assessment and exposure limit development

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