Preclinical Study Manager New

4 weeks ago

Galway, Galway, Ireland CPL Full time
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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