Research Scientist - Product development

Elanco•Indianapolis, IN

1d•Hybrid

About The Position

The Clinical Development Scientist leads the development and execution of global companion and farm animal parasiticide clinical programs that support Elanco’s innovation pipeline. The role designs, coordinates, and delivers clinical effectiveness and target animal safety (TAS) studies from early development through regulatory approval in initial target geographies. The position is listed as hybrid in Indianapolis, Indiana, with 10–20% domestic travel and potential international travel.

Requirements

A DVM or Ph.D. in Animal Science or a related field is preferred; an MS with relevant experience will be considered.
Strong project management and organizational capabilities.
Excellent written and verbal communication skills.

Nice To Haves

An advanced degree in addition to a DVM is desirable.
Experience interacting with regulatory authorities and supporting product registrations.
Working knowledge of GCP, GLP, GMP, and global regulatory frameworks.
Ability to lead and influence cross-functional teams and external research partners.
A strategic mindset and ability to drive clinical programs and align stakeholders.
Understanding of research and development processes within the animal health or pharmaceutical industries.

Responsibilities

Lead planning and execution of global clinical programs, including pilot and pivotal studies, ensuring compliance with GLP, vGCP, VICH, and other applicable regulatory standards.
Develop clinical development plans and author study protocols and reports; collaborate with cross-functional partners to deliver programs on time and to high-quality standards.
Design and oversee efficacy and target animal safety studies with Clinical Development Sciences, Biostatistics, Regulatory Affairs, and external research facilities to support global regulatory approvals.
Analyze and interpret study data with support from Data Management, Medical Writing, and internal and external reviewers; prepare documentation and support submissions and presentations to regulatory authorities and scientific forums.
Ensure quality assurance and regulatory compliance while contributing to process improvements, procedural development, and the continued advancement of clinical development practices.