Principal Preclinical Scientist
Brief Summary:
The Principal Preclinical Scientist will serve as a technical and preclinical expert, managing animal studies and contributing to the development of new neurovascular devices for a leading medical device client. The role works closely with R&D, Regulatory, and Strategic Marketing to ensure preclinical testing meets all stakeholder requirements.
Responsibilities:
1. Lead and oversee all animal studies, from design to completion, ensuring compliance with regulatory requirements.
2. Collaborate with R&D, Regulatory, and Strategic Marketing teams to align preclinical testing with project needs.
3. Develop protocols for in-vitro and animal experiments, and present findings to the First in Human Committee.
4. Design and execute complex bench and animal studies to test product limits and technical feasibility.
5. Drive innovation by utilizing exposure to clinicians and identifying unmet needs for new solutions.
6. Ensure proper documentation and manage animal studies through the Quality System.
7. Work closely with internal and external teams, including academic collaborators and Contract Research Organizations (CROs), to advance product development.
Requirements:
8. Honours degree in Biomedical Engineering, Biological Sciences, or related field.
9. 6-10 years of experience in experimental design within the medical device industry.
10. Proven experience in animal study protocol development and execution.
11. Experience with large animal studies and neurovascular/cardiovascular device design.
12. Familiarity with Good Laboratory Practices (GLP), Animal Welfare Act, and other applicable regulations.
13. Strong data review and statistical skills (Minitab).
14. Ability to manage multiple projects in a fast-paced environment.
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