Clinical Development Scientist, Companion Animal Health

Elanco•Indianapolis, IN

3d•Hybrid

About The Position

As a Clinical Development Scientist, you will be a key member of the team responsible for delivering Elanco's innovation pipeline to our customers. Your role is pivotal in bringing innovative vaccines and therapeutic products for companion animals to market, from initial study design through regulatory approval. Reporting to the Clinical Leader, you will have the opportunity to design and execute studies that advance animal well-being and support Elanco’s mission.

Requirements

A DVM or Ph.D. in a relevant scientific discipline; OR an M.S. in a relevant discipline.
A minimum of 5 years of direct experience in veterinary product development required for candidates with an M.S. degree.
Proven experience in the clinical development of health products, including hands-on involvement in planning and executing studies.
Proven ability to contribute to clinical program strategy and translate scientific objectives into executable study designs.
Strong collaboration and communication skills to effectively drive projects in a cross-functional, team-oriented environment.

Nice To Haves

Significant direct experience in the companion animal health vaccine or pharmaceutical industry.
An advanced degree (e.g., Ph.D.) in addition to a DVM.
Deep working knowledge of and direct experience with global regulatory standards (e.g., USDA, vGCP, GLP, VICH) and regulatory authorities.
Demonstrated success in managing external partnerships, such as contract research organizations (CROs).
Proven ability to take a lead role in driving a clinical program vision and cultivating innovation from development through to regulatory approval.

Responsibilities

Lead the planning, implementation, and reporting of high-quality clinical studies (pilot and pivotal) for new companion animal vaccines and therapeutics, ensuring compliance with global regulatory standards (USDA, GLP, vGCP, VICH).
Author comprehensive study protocols and final reports, select and manage contract research facilities, and oversee all aspects of study execution to meet project objectives.
Develop and execute strategic clinical development plans, fostering strong collaboration with cross-functional teams including R&D, Regulatory Affairs, Quality Assurance, and Marketing.
Partner with Regulatory Affairs to prepare and present clinical data for submission to global regulatory agencies, directly contributing to product approvals.
Drive quality and compliance within clinical programs, contribute to process improvements, and maintain current knowledge of industry trends and scientific advancements.