Working with the Head of Clinical and Medical Affairs, this role will have the following responsibilities:
- Contribute to the development and delivery of appropriate evidence generation and dissemination plans for validation and post-market clinical studies to support CMR development pipeline, with collaborative relationships with all relevant cross-functional partners (Engineering, Sales & Marketing, Quality & Regulatory Affairs);
- Develop draft study protocols, informed consents, investigator brochures, and other study materials;
- Contribute to the delivery of assigned studies, on time, within budget and in compliance with all relevant regulations and SOPs;
- Develop strong collaborative relationships with the study teams, including Investigators, research nurses, CROs, consultants, etc;
- Draft study reports, including annual reports for IRB / ECs as needed, study close out reports as well as relevant sections for regulatory submissions, such as CE, 510(k);
- Involved with critically assessing the literature and drafting Clinical Evaluation Reports;
- Support clinical scientific discussions with regulatory agencies / notified bodies to support the clinical and regulatory strategy;
- Contribute to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, study reports, and use of data/evidence for market access and reimbursement.
We’re looking for you to have:
- Good understanding of research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations;
- Ability to provide scientific research input across development and life-cycle studies;
- Leadership requirement – ability to influence, shape and lead without direct reporting authority;
- Ideally a life-science based PhD, with a minimum of 3 years’ experience in related scientific/technical/clinical research, or 5 years’ experience with a life-science Bachelor’s degree.
We offer a competitive salary and a great benefits package (including pension scheme, cycle-to-work scheme, life assurance, and childcare vouchers, and our now famous monthly company BBQs). On top of that, you’ll be joining a company with a fabulous culture of ambition, creativity and teamwork, and where fun is just as valued as our commitment to make surgery better for millions of people.
Why join us?
Cambridge Medical Robotics is developing a next-generation robotic system for universal keyhole surgery. The Versius system comprises a surgeon console, modular light-weight robotic arms and a range of wristed 5 mm instruments. The system uses state-of-the-art 3D high-definition imagery, significantly enhanced flexibility, and incorporates haptic feedback to provide surgeons with life-like sensitivity. In short, we’re creating something truly amazing designed to improve the lives of people around the globe; it’s a vision that excites us and hopefully will excite you.
Versius overcomes obstacles to widespread adoption of robotic minimal access surgery, namely robot size, instrument size, versatility, port placement, cost and ease of use, allowing the system to be highly utilised and ultimately cost-comparable to manual laparoscopic surgery.
The Company was formed in 2014 and has its headquarters in Cambridge, United Kingdom. We’re privately owned and enjoy strong financial backing.