Remote Senior Project Scientist, Animal Health Clinical Dev

Mykelly; Lincoln (NE); Remote; USD 120,000 - 180,000; Full time

Job summary

Kelly Science & Clinical is seeking a Senior Project Scientist – Clinical Development to lead pre-approval clinical development programs for livestock within the animal health field. The role is home-based (remote) with travel and will coordinate across study design, execution, regulatory submissions, and CRO oversight to support FDA CVM interactions.

The ideal candidate will have 5+ years of GxP clinical development experience in livestock, a relevant advanced degree, and strong knowledge of

Qualifications

• MS, PhD, or DVM in Animal Science, Veterinary Medicine, or a related scientific discipline; advanced degree preferred.
• 5+ years of experience executing GxP clinical development activities within the animal health industry.
• Demonstrated clinical experience with livestock, including ruminants, swine, and/or poultry.
• Advanced understanding of FDA/CVM requirements governing pharmaceutical development for livestock.
• Experience designing and executing effectiveness, target animal safety, human food safety, and/or bioequivalence studies.
• Demonstrated experience writing protocols and study reports for FDA/CVM submission.
• Experience managing clinical studies conducted through CROs.
• Regulatory Affairs experience involving FDA/CVM is highly desirable.
• Experience developing clinical development timelines and budgets is preferred.

Responsibilities

• Lead clinical development activities for pharmaceutical projects across livestock species, including ruminants, swine, and/or poultry.
• Develop and maintain project development plans, timelines, budgets, and key milestones.
• Design and execute clinical studies supporting INAD/NADA and JINAD/ANADA approvals.
• Ensure clinical development activities comply with applicable FDA/CVM, GCP, and GLP requirements.
• Design effectiveness, target animal safety, human food safety, and bioequivalence studies.
• Draft study protocols and final study reports suitable for regulatory submission.
• Coordinate analytical and statistical activities and prepare clinical data and results for submission to FDA/CVM.
• Manage studies performed by Contract Research Organizations (CROs) and ensure delivery against established timelines, quality expectations, and budgets.
• Engage directly with FDA/CVM on behalf of the organization, as appropriate.
• Collaborate with internal and external partners to ensure analytical requirements, including feed and plasma assay methods, are established for clinical studies.
• Partner cross-functionally with R&D, Regulatory Affairs, Quality, Commercial, and other stakeholders.
• Develop strategic plans for current and future product development programs.
• Identify and evaluate new product and business development opportunities.
• Establish and maintain relationships with external collaborators and partners.
• Prepare and deliver project updates and recommendations to senior leadership.
• Lead and manage multiple complex development projects simultaneously.

Skills

GxP clinical development

Livestock clinical experience

FDA/CVM regulatory knowledge

Clinical study design & execution

CRO management

Regulatory submissions

Project timelines & budgets

FDA/CVM communication

Education

MS/PhD/DVM in Animal Science or related

Job description

Kelly Science & Clinical is seeking a Senior Project Scientist – Clinical Development to lead pre-approval clinical development programs for livestock within the animal health field. The role is home-based (remote) with travel and will coordinate across study design, execution, regulatory submissions, and CRO oversight to support FDA CVM interactions.

The ideal candidate will have 5+ years of GxP clinical development experience in livestock, a relevant advanced degree, and strong knowledge of