01Responsibilities
Serve as Study Director for pre-clinical GLP safety studies and as a Study Investigator for GCP studies, contributing to the design and execution of pivotal and non-pivotal clinical trials with a focus on small molecule, pain, and dermatology models.
Manage the full lifecycle of study documentation, including the development and completion of protocols and final reports, and oversee the maintenance of related SOPs, templates, and forms.
Ensure full compliance with all internal and external guidelines (GLP, GCP, SOPs, Animal Welfare) and applicable regulations, including overseeing study conduct per 21 CFR Part 58 and managing the archival of all study data and specimens.
Maintain robust communication across diverse, cross-functional teams (e.g., QA, regulatory affairs, statistics, project teams) and coordinate key study components like protocol training and investigational veterinary product (IVP) supply management.
Assemble and secure Institutional Animal Care and Use Committee (IACUC) approval for all clinical studies and support patent or publication efforts as needed.
What You Need to Succeed (minimum qualifications):
Education & Experience: MS with 4+ years of experience, BS with 7+ years of experience, or a Doctorate (PhD, DVM, MD) with 2+ years of experience in a relevant industry.
Clinical Study Experience: Demonstrated experience managing the initiation, execution, and completion of clinical studies, with specific expertise in small molecule research and/or studies involving pain and dermatology models.
Communication & Collaboration: Strong verbal and written communication, presentation, and technical writing skills, with a proven ability to work effectively in cross-functional teams.
What will give you a competitive edge (preferred qualifications):
Direct experience with clinical study management within the Animal Health industry.
Familiarity with both FDA/CVM and EU regulatory guidelines, particularly for small molecules.
Experience coordinating diverse clinical groups such as regulatory, laboratories, execution teams, and veterinary/animal care staff.
Strong organizational, time management, and analytical problem-solving skills.
A background that includes experience with biological vaccines and large molecules.
Additional Information:
Travel: Up to 10% Location: Fort Dodge, IA Don't meet every single requirement Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work workplace. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
Multiple relocation packages
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements .
