The successful candidate will also manage activities associated with Veterinary Clinical Trials including Target Animal Safety studies, and Efficacy studies for Veterinary projects.
To ensure that project plans and milestones are delivered according to agreed timelines
- Together with the Head of Scientific Affairs and in collaboration with the Regulatory Affairs Manager, actively plan the Veterinary Clinical function requirements ensuring major milestone targets for each product are visible to all team members and key stakeholders to achieve on time market entry.
- Together with the Head of Scientific Affairs and in collaboration with the Regulatory Affairs Manager, determine tasks and resources required to deliver each project milestone and deliverable.
- Design and manage all clinical trials associated with the Veterinary projects including target animal safety and efficacy studies in collaboration with external experts and Clinical Research Organisations.
- Identify and manage external resources required to ensure completion of the necessary studies to achieve the target milestones. Travel to clinical sites may be required to ensure Sponsor oversight of the studies
- In collaboration with the Regulatory Affairs Manager, manage the preparation of relevant dossier sections to support Veterinary license applications including the relevant sections of Modules 2, 4 and 5.
- Coaching/mentoring - support members of team with problem solving and skills development to aid learning and early problem resolution
- Manage applicable clinical affairs budget and cost centre activities required for veterinary clinical activities.
Minimum Qualifications & Experience:
Bachelor of Veterinary Medicine
Significant clinical practice experience in companion animal space, ideally to include clinical research and in a cGxP environment.
Familiarity with cGxP in pharmaceutical manufacturing
Technical knowledge of clinical research in the Veterinary space, with emphasis on small animal practice
Familiarity with concepts of Regulatory Approval process for veterinary pharmaceutical products
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