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Job Description
Seeking a Principal Preclinical Scientist to lead animal testing and preclinical activities for a medical device multinational.
Reporting to the Medical Director, the successful candidate will take ownership of animal testing and become the company SME.
The role will work collaboratively with R&D, Regulatory, Strategic Marketing, and Quality to develop and perform preclinical activities.
Key Responsibilities:
- Acquire in-depth knowledge of current products in development from a technical and usability point of view.
- Serve as study sponsor representative for animal experiments, including feasibility studies and GLP studies.
- Evaluate new and current animal labs and identify neuro-interventionalists with animal intervention background.
- Develop and maintain an inventory of Notified Body requirements and responses for animal testing.
- Create a 'test-to-fail' strategy for bench testing on products in development.
- Develop a mechanism to receive requests for preclinical testing and generate evidence for regulatory questions.
- Develop and implement complex experiments and be responsible for protocols, reports, and presentations.
- Ensure documentation to appropriate standards and manage documents through the Quality System.
- Participate in new product development as a core team member representing preclinical strategy.
- Provide input on study designs and interpretations during the product development cycle.
- Identify and manage key preclinical risks throughout the product lifecycle.
- Effectively collaborate with external collaborators, such as academic, Contract Research Organizations, and biotech partners.
Requirements:
- Honours degree in Biomedical Engineering, Biological Sciences, or related medical/scientific field.
- Advanced scientific degree (Masters or Ph D) in an experimental design field, or equivalent experience.
- 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.
- 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.