Head of Clinical Operations
We’re looking for an experienced clinical affairs expert to lead and manage our relationships with the surgical community, and to take responsibility for clinical development activity as we bring to market the next generation of surgical-assist robot.
In this role, you’ll be responsible for our relationship with the Medical Advisory Board (MAB) and other external surgeons and medical personnel, liaising closely with the Chairman of the MAB and the Senior Management team. You’ll also be:
- Able to develop effective relationships and rapport with colleagues and surgeons as well as the relevant regulatory authorities such as RECs, Notified Body and the US FDA
- An excellent communicator and a strong team player
- Able to promote, develop and extend the business of Cambridge Medical Robotics
- Liaising with the MAB, chief and principal investigators and the Head of Quality and Regulatory Affairs to generate clinical study protocols as well as developing and collating the supporting documentation required to obtain the corresponding REC approvals
- Managing all aspects of clinical and pre-clinical activities including cadaver and animal studies
- Helping to develop clinical evaluation protocols, performing literature searches and subsequent reporting
- Supporting post market surveillance and conducting post-market clinical follow up studies
Heading up our clinical operations, you’ll have a practical hands-on approach and a willingness to take responsibility and ownership for this crucial function.
Your reputation, enthusiasm and experience will be key in helping us to present a professional image amongst the surgical community, properly reflecting our truly innovative, world-class, and game changing robotic technology. To do so, you may be required to travel from time to time.
Experience and Qualifications:
- Bachelor’s degree in Medicine, Engineering, Science or Mathematics
- Previous use of the Integrated Research Application System (IRAS) and Research Ethics Committee (REC) procedures
- Has successfully managed a number of clinical studies on a number of medical device products
- Has provided input to the CE marking and US FDA 510(k) submission process
- Good working knowledge of ICH-GCP, ISO 14155
- Familiarity with surgical procedures in operating room environments
We offer a competitive salary and a great benefits package (including pension scheme, life assurance, private medical, childcare vouchers, cycle-to-work scheme and discretionary bonuses subject to corporate milestone achievements, 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.