We’re looking for an experienced and passionate Head of Clinical Affairs to join our rapidly growing team. Reporting to our Executive, you will lead the Clinical Team as we bring our next-generation surgical robotic system to market. As the Head of Clinical Affairs, you will take charge of defining clinical/pre-clinical strategies and development activities to ensure we meet business objectives, while leading and managing our relationships with the surgical community.
Why join us?
CMR is one of the UK’s most exciting companies to be joining right now. The scale of our ambition to build a world-class medical devices company in Cambridge is matched only by the breathtaking innovation that underpins our next generation of surgical robot. We’re an award-winning company that plans to significantly disrupt the way surgery is performed for the benefit of millions of patients all around the world.
Our values are ambitious, humble, people focused and fair and responsible. If you share these values, our passion for improving lives, and have the skills to make a real difference to the way minimal access surgery is developed and delivered, then it’s a great time to join us.
You will define and execute our pre-clinical and clinical research strategy to support both the regulatory framework and the commercial business strategy and take responsibility for:
- Our relationship with the Medical Advisory Board (MAB) and other external surgeons and medical personnel
- Liaising with the MAB, chief and principal investigators and the Head of Quality and Regulatory Affairs to generate clinical and pre-clinical study protocols as well as developing and collating the supporting documentation required to obtain the corresponding REC approvals
- The delivery of all aspects of clinical and pre-clinical activities including cadaver and animal studies
- The design and successful execution of pre-clinical studies and clinical trials demonstrating medical device safety and efficacy, ensuring trials are conducted in full compliance to GCP and all other applicable regulatory requirements.
- Developing effective relationships and rapport with colleagues and surgeons as well as the relevant regulatory authorities such as RECs, Notified Body and the US FDA
- Ensuring effective translation of insights and feedback from clinical and pre-clinical work to both the R&D teams and Professional Education teams to ensure the continued improvement in clinical and educational performance.
- Leading a team ensuring individuals development and performance in role
- Ensuring all studies and documented clearly and concisely for regulatory submissions and publications
- Promoting, developing and extending the business of CMR Surgical
- Leading the development of clinical evaluation protocols, performing literature searches and subsequent reporting
- Supporting post market surveillance and conduct post-market clinical follow up studies
- We’re a high growth company and as such roles change and evolve.
We’d expect you to be willing to turn your hand to anything within the clinical and pre-clinical remit that helps the team deliver its objectives.
Heading up our clinical affairs, 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 enabling 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.
A natural communicator hopefully goes without saying, but in addition we’d like you to have:
- An excellent communicator and a strong team player
- Bachelor’s degree in Medicine, Engineering, Science or Mathematics
- Provided input in the CE marking and US FDA 510(k) submission process
- Previous use of the Integrated Research Application System (IRAS) and Research Ethics Committee (REC) procedures
- Successfully managed a number of clinical studies on a number of medical device products
- Good working knowledge of ICH-GCP, ISO 14155
- Familiarity with surgical procedures in operating room environments
- a genuine desire to help and support team members so that we can all achieve our best
We offer a competitive salary and a great benefits package (including non-contributory pension scheme, cycle-to-work scheme, life assurance, and our infamous monthly 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.
Interested? We’d love to hear from you!