Senior Clinical Research Associate

Seeking a highly skilled and experienced Principal Preclinical Scientist to join our team.

This is a contract position that plays a key role in the Medical Affairs department.

The successful candidate will serve as the technical and preclinical expert on cross-functional project teams, responsible for all animal studies. The role collaborates closely with R&D, Regulatory, and Strategic Marketing to ensure preclinical testing meets the needs of all stakeholders. Additionally, the position contributes to in-vitro test design and leads complex in-vitro studies to support project objectives and substantiate marketing claims.

1. Develop an in-depth knowledge of current products in development from a technical and usability point of view: design, materials, performances, manufacturing process, clinical workflow.
2. Serve as study sponsor representative for animal experiments (including feasibility studies, GLP studies), accountable for concept to completion of the studies, including defining the model requirements, developing protocols and reports, and presenting to First in Human Committee.
3. Evaluate new and current animal labs, become point of contact for logistics and communication.
4. In collaboration with Regulatory, develop and maintain an inventory of Notified Body requirements and responses over the years for animal testing.
5. Design a 'test-to-fail' strategy to conduct bench testing on products in development to characterise their limits from a usability point of view, using in-house physicians and engineers to perform the testing.
6. Effectively work with NTI, our in-house advanced science and modelling group, to coordinate and utilise the NTI lab, models and technologies for related bench testing, and provide input for improvement.
7. Develop and implement highly complex experiments, including deep dives on the technical feasibility or test-to-failure experiments. Responsible for protocol development, report writing, and presentations to address the research or regulatory questions collaborating with R&D, NTI, Quality, and Regulatory for all animal experiments and relevant bench studies.
8. Utilise exposure to clinicians to identify areas of unmet need and utilise this information to innovate new solutions.
9. Participate in new product development as a core team member, representing physician needs and practical use. Practical problem solving required.
10. Participate in Target Product profile (TPP) generation, bringing physician needs and preclinical testing experience to drive align TPPs with areas of greatest need.
11. Identify and manage of key preclinical risks throughout the product lifecycle.
12. Ensure documentation to appropriate standards and responsible for managing the documents through the Quality System.
13. Effectively collaborate with external collaborators, such as academic, Contract Research Organizations (CRO), and biotech partners.

1. Honours degree in Biomedical Engineering, Biological Sciences, or related medical / scientific field.
2. A minimum of 6-10 years' experience in experimental design within the medical device industry.
3. Strong design and technical ability based on a broad and deep knowledge of fundamental scientific principles.
4. Specific experience in large animal study design and execution in the medical device industry with awareness of regulatory submission pathways to evaluate neurovascular or cardiovascular devices or implants such as catheters, stents, delivery systems.

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up to date CV.

Our company cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland.