Animal Health Sr Project Scientist

Kelly Services; Lincoln (NE); Remote; USD 140,000 - 200,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision care

Retirement plan

Paid holidays

Job summary

Kelly Science & Clinical seeks a Senior Project Scientist – Clinical Development to lead pre-approval clinical programs for livestock pharma products. This role oversees study design, regulatory submissions, and CRO oversight, with travel expected. Strong GxP experience and FDA/CVM knowledge are required.

The position emphasizes strategic planning, cross-functional collaboration, and timely delivery of complex development programs within a home-based (remote) setting.

Qualifications

• 5+ years of GxP clinical development experience in the animal health industry.
• Advanced understanding of FDA/CVM requirements governing livestock pharmaceutical development.
• Experience designing and executing effectiveness, safety, and bioequivalence studies.
• Experience writing protocols and study reports for FDA/CVM submission.
• Experience managing clinical studies conducted through CROs.

Responsibilities

• Lead clinical development activities across livestock species (ruminants, swine, poultry).
• Develop and maintain project development plans, timelines, budgets, and milestones.
• Design and execute studies for INAD/NADA and JINAD/ANADA approvals.
• Ensure compliance with FDA/CVM, GCP, and GLP requirements.
• Coordinate analytical and statistical activities for regulatory submission.

Skills

GxP experience

FDA/CVM knowledge

CRO oversight

Project leadership

Education

MS/PhD/DVM in Animal Science

Job description

Senior Project Scientist – Clinical Development

Animal Health | Livestock Clinical Development | Home-based (Remote) with Travel

Kelly® Science & Clinical is seeking a Senior Project Scientist – Clinical Development for an opportunity within the animal health industry. This position will lead pre-approval clinical development programs supporting new pharmaceutical products for livestock.

The Senior Project Scientist will provide scientific and project leadership across clinical development activities, including strategic planning, study design and execution, regulatory submissions, CRO oversight, and interactions with FDA’s Center for Veterinary Medicine (CVM). The successful candidate will have substantial experience conducting GxP clinical studies in livestock and a strong understanding of regulatory requirements for animal health pharmaceutical development.

Compensation: dependent on on experience and qualifications

Travel: 25-50%

Key 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.

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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .

Kelly Services is proud to be an Equal Employment Opportunity and Affiantive Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.