Sr. Clinical Scientist - Veterinarian

Virbac•Westlake, TX

42d•Onsite

About The Position

Virbac Animal Health is seeking a Senior Clinical Scientist - Veterinarian to join our team. Within the framework of Virbac strategy, the Sr. Clinical Scientist - Veterinarian will define a plan and execute/ implement preclinical and clinical projects (Target animal safety study, bioequivalence study, pilot and pivotal animal studies, literature analysis, analysis of technical feasibility and other technical tasks) directly or indirectly (though peers and/or direct reports) to support US and global Product Development projects. All clinical projects will lead to the registration and/or commercial launch of new products (pharmaceutical or biopharmaceutical), maintenance of existing products and or technical support for the establishment and maintenance of the pipeline portfolio.

Requirements

DVM/VMD or equivalent training and experience from a foreign veterinary training program; And/or graduation in the Biological field.
Ten or more years of clinical experience in veterinary practice and five or more years of experience in the Regulated Animal Health Industry Research and Development area.
Documented experience in the conduct of VICH/ICH GCP studies is required for this position.
Ability to travel up to 20%.

Nice To Haves

Project management training or certification preferred.
Texas Veterinary Licensure preferred.

Responsibilities

Understand and continually acquire advanced knowledge of the regulatory framework for development activities (veterinary GDP, GLP and GCP regulations) in the USA.
Participate in pre-study planning and the generation or review of training documents and presentations.
Ensure the execution of some preclinical studies in support of the Preclinical Team or for local projects.
Contribute to the definition, create clinical development plans, and ensure the execution of them through collaboration with the Project Team members, the Project technical Leaders and/or the Clinic Team of another subsidiary or external partner.
Ensure the oversight of the ongoing subcontracted studies or 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, monitoring plans, study support documents, change control documentation, risk analyses, clinical training documents and basic regulatory documents (NCIEs, meeting slides, briefing document, technical section components), final study reports.
Coordinate CRO-based activities to complete scientific tasks in a timely manner, understand the working process to anticipate possible impacts towards other related internal partners.
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.
Maintain study documentation and support document management and archiving activities.
Manage data flow throughout the study: data form design, data capture, data review, data analysis and final reporting.
Support study archiving through the authoring of final reports, abstracts or close-out documentation.
Support other R&D centers or Regulatory teams for what concerns the clinical and preclinical activities.
Builds long term effective relationships and open communication with Virbac Headquarters and other external partners in order to provide accurate information and timeframes.
Participates in project R&D meetings to discuss clinical development issues and develop clear project plans with realistic milestones.
Provides technical support, advice and strategy to other teams within Virbac (e.g. R&D, marketing, quality, formulation, regulatory, and manufacturing sites).
Liaises with other departments to perform clinical functions e.g., Run QC reviews and audits to ensure complete and accurate data output from all studies.
Represent the Performance Team within the Corporate project teams for the Clinical function.