Clinical Affairs Manager (Veterinary)

ICDS RECRUITMENT

WATERFORD

Clinical Affairs Manager (Veterinary)- Waterford. Core Purpose: To support the Head of Scientific Affairs with clinical activities associated with the registration of Veterinary products in Worldwide markets with emphasis on US and EU. 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. Core Responsibilities: Project Planning/Co-ordination. 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. Clinical Studies. 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. Dossier preparation. 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. Leadership. Managing a small team of clinical experts to support the Veterinary portfolio development. 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. Veterinary Business Strategy. Together with the Business Development Manager and relevant technical experts, support existing veterinary partnerships with external partners as well as working to identify new development opportunities for the development of veterinary medicines. 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. Familiarity with concepts of Regulatory Approval process for veterinary pharmaceutical products. Technical knowledge of clinical research in the Veterinary space, with emphasis on small animal practice. Working knowledge of EDMS (Electronic Document Management System.

1610 days ago