Principal Preclinical Scientist
RK2868
Contract - 12 months
Galway



We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Galway. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



The role works closely with the R&D, Regulatory and Strategic Marketing teams to ensure pre-clinical testing addresses all stakeholder requirements. In addition, the role provides input on in-vitro test design as well as leading highly complex in-vitro testing to support project needs and to support marketing claims.



Duties:

• Acquire an in-depth knowledge of current products in development from a technical and usability point of view: design, materials, performances, manufacturing process, clinical workflow
• Serve as study sponsor representative for animal experiments (including feasibility studies, GLP studies), and accountable for concept to completion of the studies, including defining the model requirements, developing protocols and reports, and presenting to First in Human Committee.
• Evaluate new and current animal labs, become point of contact for logistics and communication.
• In collaboration with Regulatory, develop and maintain an inventory of Notified Body requirements and responses over the years for animal testing.
• Create 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.
• 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.
• 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.
• Utilise exposure to clinicians to identify areas of unmet need and utilise this information to innovate new solutions.
• Participate in new product development as a core team member, representing physician needs and practical use. Practical problem solving required.
• Participate in Target Product profile (TPP) generation, bringing physician needs and preclinical testing experience to drive align TPPs with areas of greatest need.
• Identify and manage of key preclinical risks throughout the product lifecycle.
• Ensure documentation to appropriate standards and responsible for managing the documents through the Quality System.
• Effectively collaborate with external collaborators, such as academic, Contract Research Organizations (CRO), and biotech partners.

• Honours degree in Biomedical Engineering, Biological Sciences, or related medical / scientific field.
• A minimum of 6-10 years’ experience in experimental design within the medical device industry.
• Prior experience developing animal study protocols.
• Strong design and technical ability based on a broad and deep knowledge of fundamental scientific principles.