Principal Preclinical ScientistOur client, a medical device multinational, is currently seeking a Principal Preclinical Scientist to join their team. Reporting to the Medical Director, the Principal Preclinical Scientist will take ownership and become the company SME on animal testing. The role works collaboratively with R&D, Regulatory, Strategic Marketing, and Quality to be a leading partner in developing and performing preclinical activities (both animal and in-vitro) to generate evidence for regulatory and clinical acceptance as well as for competitive claims for launch. The role has overall responsibility for animal experiments as the study sponsor representative and is accountable for 'test-to-fail' bench testing at any phase of development. This is a new and unique opportunity, and the successful applicant will have the opportunity to scope and grow the role according to their own vision.
Role/Responsibilities: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 the First in Human Committee.Evaluate new and current animal labs, becoming the point of contact for logistics and communication.Identify and contract neuro-interventionalists with animal intervention background to perform procedures.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 characterize their limits from a usability point of view, using in-house physicians and engineers to perform the testing.Develop a mechanism to receive all requests for preclinical testing involved in characterizing the limits of a product in development, generating evidence for additional regulatory questions beyond the initial launch in the primary country, or for marketing claims to show competitive advantage for products in development or already launched.Develop and implement highly complex experiments and be responsible for protocols, reports, and presentations to address the research or regulatory questions collaborating with R&D, Quality, and Regulatory for all animal experiments and relevant bench studies.Ensure documentation to appropriate standards and be responsible for managing the documents through the Quality System.Participate in new product development as a core team member representing preclinical strategy.As a core team member and subject matter expert, provide input on study designs and interpretations during the product development cycle based on the Target Product Profile (TPP).Evaluate the appropriateness of questions in the voice of the customer (VOC) and interpret their answers for the benefit of the team.Identify and manage key preclinical risks throughout the product lifecycle.Effectively collaborate with external collaborators, such as academic, Contract Research Organizations (CRO), and biotech partners.Other duties as assigned or required.Skills/Experience:Honours degree in Biomedical Engineering, Biological Sciences, or related medical/scientific field.Advanced scientific degree (Masters or PhD) in an experimental design field, or equivalent experience (Desirable).A minimum of 6-10 years' experience in experimental design within the medical device industry.Strong design and technical ability based on a broad and deep knowledge of fundamental scientific principles.Data review and statistical methods skills (Minitab).Strong work ethic, creative problem solving, capable of working on own initiative.Excellent writing, presentation, and verbal communication skills essential.Specific experience in large animal study design and execution in the medical device industry with awareness of regulatory submission pathways to evaluate devices or implants such as catheters, stents, delivery systems (Desirable).Awareness of Good Laboratory Practices, the Animal Welfare Act, and all other applicable regulations.Results and deadline driven with an ability to handle multiple tasks and operate in a fast-paced environment.Excellent social skills and ability to work with people to achieve results.Highly motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player.For further information please contact James Cassidy at ****** or call in confidence 086 02024322.
#J-18808-Ljbffr