Our client has recently secured funding through early 2024 and plans additional fundraising by mid-2023. The company now seeks a Chief Technology Officer to take gradual ownership of all R&D activities, initially on a part-time basis. This role will play a vital part in the development of a prognostic portfolio with the potential to impact over 49M sepsis patients annually, together with a broader portfolio targeted at broader infectious disease management.
The successful candidate will, over time, lead development of company’s clinical trial program & technology portfolio, and support the CEO with oversight of vendors/partners to ensure transition to an ISO13485-compliant development & manufacturing process.
The role requires a degree in molecular biology, biochemistry or a related discipline with significant expertise in IVD industry R&D leadership experience, including a track record of successful medical product development • Significant hands-on technical experience in technologies such as molecular biology, immunoassay, and lateral flow. Knowledge/experience of AI-driven innovation is sought ideally including both clinical and “omic” parameters. Development experience setting up and/or operating within an ISO13485-compliant environment; familiarity with FDA CFR part 820 requirements is sought and Ideally Knowledge of development of regulated medical software and AI and other applicable international standards, including ISO/IEC 27001 and ISO/IEC 27701.
Geographic location is flexible. The company anticipates being able to offer an attractive salary and incentives package to a candidate willing to initially join on a flexible basis with, ideally, a transition to full-time; 80% within 6- 12 months.
More information available on request.