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Clinical Research Veterinarian

3 months ago

Westlake, United States Virbac Full time
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.
  • Supports other teams within Virbac as required (e.g. R&D, marketing, quality, formulation, regulatory, and manufacturing sites).
  • Liaises with other departments to perform clinical functions e.g., Coordinate and support Quality Assurance personnel in completing QA and QC reviews and audits to ensure complete and accurate data output from all studies.
Expected results

Facilitate the development of Clinical submissions that meet regulatory requirements and business objectives.

Area of responsibility 3: Represent the Clinical function within the US Clinical Team and Corporate R&D project teams
  • Participate in defining and updating the R&D development plan (process, analytical, clinical, regulatory parts) by providing the clinical expertise necessary for any projects (Corporate and/or local ones),
  • Liaise with the other members of the project team to guarantee consistency in the progress of development within each party; in case of issue/hurdle, communicates towards partners, analyzes impact within the project team and proposes solutions.
  • Define the needs in terms of product quality and quantities for each step (evaluation, PP, PID): experimental lots, pilot lots, clinical batch
  • Share scientific expertise to help resolve the setbacks encountered by the project team to improve the timelines or the costs
  • Transmits its know-how in terms of carrying out tests, compliance with the Virbac ethical charter and the world R&D best practices reference guide (good scientific practices),
  • Lead the clinical technical discussions required for the project, provide reporting to the project team; triggers and animates if needed ad hoc discussions to fix specific technical questions
  • Prepare PPM (project progress meeting) and the applicable technical tasks forces with his manager/function report to validate the actions proposed in terms of clinical development.
  • Professional organizations: participate to national or international industry groups according to Virbac priorities e.g. AHI, AAVPT, CAPC working groups. The level of participation can range from an active participation to chairing the working groups.
Expected results

Contribute to the development of products by representing the clinical expertise within the US Clinical Team and within the Corporate R&D project teams.

Know-how : job-related skills required to complete activities
  • Working knowledge of Good Clinical Practices, Good Laboratory Practices, Good Documentation Practices and the Code of Federal Regulations relevant to FDA/CVM and EPA
  • Working knowledge of Google and Microsoft suites and electronic data capture (EDC Systems)
  • Advanced scientific writing competency
  • Regulations regarding the use of animals in research
  • A thorough knowledge of and competency in the current standards of veterinary clinical practice
  • Languages (specify level): Fluent English
Behaviors : Interpersonal skills required to complete activities
  • Communicate effectively and influence others
  • Demonstrate adaptability and self-development
  • Analyze problems and situations
  • Organize activity
  • Manage execution showing drive and results orientation
  • Foster dialogue and build relationships with a "warm and caring" attitude
  • Promote collaboration across functional & geographical boundaries
Cross-functional Relationships which may impact the job's activities (optional)

1. Interaction with other Virbac departments and sites

2. Regulatory Affairs Personnel, Pharmaceutical Development Personnel, and R&D Project Managers

3. Interaction with vendors, consultants, CROs and outside clinics

Training/ Experience necessary to fulfill the job

Educational level or equivalent experience
  • DVM/VMD or equivalent training and experience from a foreign or North American based veterinary training program.
Total number of years of experience required to fulfill the role
  • 5+ years of clinical experience in veterinary practice and 3+ years of experience in the Regulated Pharmaceutical Animal Health Industry.
  • Parasitology product and clinical experience a plus.
Career prerequisite
  • Documented experience in the conduct of VICH/ICH GCP studies is required for this position.
  • Ability to travel up to 30%.
  • Project management training or certification preferred. Texas Veterinary Licensure preferred.
Location
  • Dallas, TX; Saint Louis, MO; or Remote, United States.


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