Animal Health Sr Project Scientist

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

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.

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