Lead Livestock Clinical Development Scientist

Huvepharma; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Huvepharma in the United States is seeking a Senior Project Scientist of Clinical Development to lead pre-approval studies and strategic planning for INAD/NADA and JINAD/ANADA approvals in livestock.

The role requires MS/PhD/DVM in a relevant field, 5+ years of GxP clinical experience, and strong regulatory affairs knowledge to interact with FDA/CVM and CROs.

You will manage timelines, budgets, and cross-functional teams, delivering high-quality data and reports for regulatory submissions.

Qualifications

• MS, PhD or DVM in animal sciences or veterinary medicine; advanced degree desirable.
• 5+ years of clinical experience with livestock (ruminants, swine, poultry).
• Experience executing GxP clinical activities in the animal health industry.
• Experience with development timelines and budgets desirable.
• Regulatory Affairs experience with FDA/CVM desirable.

Responsibilities

• Lead clinical activities for pharmaceutical projects across livestock species.
• Generate and maintain project development plans, timelines, and budgets.
• Ensure activities comply with FDA/CVM regulations.
• Design clinical studies, draft protocols, execute per GCP/GLP, analyze data, draft reports.
• Coordinate with CROs to execute studies.
• Engage with FDA/CVM as needed.
• Collaborate with internal/external partners on analytical requirements.
• Develop strategic plans for future development projects.
• Identify and evaluate new product and business opportunities.
• Build external partnerships to enhance collaborations.

Skills

GxP clinical activities

Regulatory Affairs

Leadership

Cross-functional collaboration

Project management

Data analysis

Clinical study design

Communication

FDA/CVM liaison

Strategic planning

Education

MS/PhD or DVM in animal sciences or veterinary medicine

Job description

Huvepharma in the United States is seeking a Senior Project Scientist of Clinical Development to lead pre-approval studies and strategic planning for INAD/NADA and JINAD/ANADA approvals in livestock.

The role requires MS/PhD/DVM in a relevant field, 5+ years of GxP clinical experience, and strong regulatory affairs knowledge to interact with FDA/CVM and CROs.

You will manage timelines, budgets, and cross-functional teams, delivering high-quality data and reports for regulatory submissions.