- To support the Head of Scientific Affairs with clinical activities associated with the registration of EirGen/OPKO 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.
Responsibilities of this role include:
1. Project Planning/Co-ordination
- Together with the Head of Sceintific 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.
2. 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.
3. 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.
- Managing a small team of clinical experts to support the Veterinary portfolio development at EirGen.
- 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.
5. Veterinary Business Strategy
- Together with the Business Development Manager and relevant technical experts within EirGen, support existing veterinary partnerships with external partners as well as working to identify new development opportunities for the development of veterinary medicines for EirGen.
The ideal candidate for this role should meet the following qualification and experience criteria:
Bachelor of Veterinary Medicine Significant clinical practice experience in companion animal space, ideally to include clinical research and in a cGxP environment.