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