Clinical Research Veterinarian

Experiencing together a unique human adventure

Animal health is key to the health of the planet. Working at Virbac means taking part in a unique human adventure in which the engagement of each individual contributes to its evolution. Encouraging internal mobility between positions and countries, offering individual development plans and building a partnership based on trust between managers and employees are as many perspectives of motivation for our teams. We also offer them a work environment conducive to exploring new territories and balancing their professional and personal lives. Finally, fostering their engagement to animal health also means listening to them and helping them to acquire new skills, preparing them for the challenges of tomorrow and encouraging them to contribute to an ever more responsible approach to our business.  

Within the framework of Virbac U.S. strategy, the Clinical Research Veterinarian will plan and execute clinical projects (pilot and pivotal animal studies, literature analysis, analysis of technical feasibility and other technical tasks) to support US and global Product Development projects and existing commercial products.

Area of responsibility 1: Plan, Execute, and Report Clinical Studies for Animal Drug Development

• Understand and continually acquire advanced knowledge of the animal pharmaceutical regulatory framework for clinical and development activities (veterinary GDP, GLP and GCP regulations) in the USA.
• Ensure the scientific and technical knowledge necessary for the project by a regular review of the literature.
• Participate in pre-study planning and the generation or review of training documents and presentations.
• Define the study outlines and the study roles and responsibilities within internal teams and external partners.
• Select appropriate subcontractors (CROs) to manage studies. Working closely with Procurement, Finance, and Legal Departments.
• Working with the Quality Department assuring the adequate qualification of selected CROs, on site audits as required, existence of appropriate SOPs, presence of a data management system (including electronic data management system) and compliance with GCP/GLP guidelines.
• Review study data throughout the study lifecycle to evaluate the quality of the data, trends within the data and to prepare for final analysis - Assist in establishing a monitoring plan for the studies.
• Author protocols and study support documents, change control documentation, clinical training documents and regulatory documents (NCIEs, meeting slides, technical section components with support of Regulatory personnel).
• Comply with local regulations (ensure trial declaration/test permits are in place, product labeling requirements and import permits are followed, pre-submission conference and protocol concurrence with CVM are requested and prepared, etc.)
• Request and obtain an animal welfare and ethics approval.
• Coordinate CRO-based activities to complete scientific tasks in a timely manner- Author Final Study Reports, compile all quality reviewed study documents and assemble submission ready components of dossiers/ Technical Sections or product development files -Review protocols, reports and scientific documents generated by other members of the clinical team or research partners.
• Monitor or support Clinical Operations Manager monitoring clinical studies taking appropriate mitigation measures in case of gaps.
• Maintain study documentation and support document management and archiving activities.
• Support Data manager with the data flow throughout the study: data form design, data capture, data analysis during soft and hard locks, and final reporting.
• Support study archiving through the authoring of final reports, abstracts or close-out documentation.

Expected results

Guarantees the clinical development of new products by defining and executing a clinical development plan ensuring the effectiveness and safety of the use of these products while respecting costs, deadlines and regulatory constraints.

Area of responsibility 2: Cross-Functional Collaboration for Drug Development

• Participates in project development meetings to discuss clinical development issues and develop clear project plans with realistic milestones.
• Contribute to the definition and ensure the execution of the clinical plan in various drug development phases (from Exploratory to Regulated phases).
• Identify and classify project main risks, and propose adequate risk mitigation measures.
• Inform line management and project team of the progress of the clinical development plan. Alert in the event of an incident or setback proposing mitigations or modifications to the development plan.
• Su