Head of Clinical Operations

About the company Neuronostics is a multi-award-winning medical technology company, spun out of the University of Exeter in 2018. Since then, we’ve been supported by research grants and private equity of more than £5M, enabling us to rapidly grow our team as we seek to accelerate our route to market. Our mission is simple: to revolutionise diagnosis and treatment of neurological conditions. We achieve this through the development of digital biomarkers that can be measured from data that is routinely collected clinically. Our current focus is on epilepsy: a serious brain disorder that affects over 600,000 people in the UK alone. We have developed the first digital biomarker of epilepsy (BioEP) that can reveal the risk of future seizures from routinely acquired measurements of the brain’s electrical activity (EEG). BioEP as Software as a Medical Device (SaMD) will be used by healthcare professionals to assist the diagnosis and prognosis of epilepsy, to ultimately improve the treatment and care pathway for those living with epilepsy or suspected epilepsy. We are conveniently located in the Engine Shed by Bristol Temple Meads Station, we are part of the internationally recognised SETsquared incubator. This provides access to experts in the fields of business, marketing, technology and legal who act as mentors. It’s an exciting ecosystem of other start-ups to work within, all learning from and supporting each other on the road to success. The Role of Head of Clinical Operations This is an exciting opportunity to provide clinical operations leadership at a time of significant growth and international expansion, as we focus on FDA submission in 2026.​ We are looking for a dynamic and methodical individual to lead efforts to develop, manage and optimise clinical operations that drive regulatory success and commercial growth whilst enhancing the company's impact in neurology. ​ This senior role is critical in expanding Neuronostics' reach through our programme of clinical studies in the UK and internationally, working closely with executive leadership to develop clinical strategies aligned with business goals and manage relationships that contribute to long-term success. In this role you will: Develop and implement a comprehensive clinical operations strategy that aligns with Neuronostics' business objectives, focussed on both regulatory and commercial success.​ Lead the development of our international clinical strategy, including FDA submission pathway and US market entry.​ Lead and develop our clinical operations teams, including acting as a coach and mentor as we rapidly scale.​ Establish and manage systems for remotely overseeing clinical trials in the USA, ensuring compliance with FDA regulations and Good Clinical Practice guidelines.​ Build and maintain relationships with US clinical sites, CROs and regulatory consultants to ensure successful international trial delivery.​ Oversee all operational aspects of trials, including delivery of studies on time, within budget and scope.​ Develop, review and approve study documents including protocols, statistical analysis plans, and clinical study reports. ​ Foster collaborative partnerships with clinical sites, recognising their strategic value as both research partners and commercial customers, carefully balancing clinical rigour with customer relationship management. ​ Work closely with our technical, scientific, operations and commercial teams to ensure an integrated approach to our clinical operations.​ Provide clinical operations guidance to executive leadership and the wider Neuronostics community. ​ Enhance and optimise our existing clinical operations infrastructure.  Essential Experiences Education: Degree in life sciences, ideally Biomedical Sciences, Medicine or related discipline.​ Clinical Operations Leadership: Minimum 5-8 years professional experience in clinical research and clinical trials management, with at least 3 years in leadership roles.​ Trial Management Experience : Experience with remotely managing clinical trials, ideally including overseas (especially the USA), including understanding of FDA regulations and cross-border compliance. ​ Regulatory Knowledge: Extensive knowledge of clinical trial methodology and global clinical development processes, including ICH-GCP and FDA regulations governing clinical trials.​ Commercial Acumen : Understanding of how clinical operations support commercial objectives, with ability to balance scientific rigour with business needs and customer relationship management.​ Documentation and Reporting : Significant experience developing study protocols, case report forms, clinical study reports and regulatory submission documents .​ Quality Management: Understanding of quality assurance principles and experience ensuring trial compliance with relevant guidelines and regulations.​ Analytical and Problem-Solving Skills: Excellent communication, negotiation and problem-solving skills with ability to work effectively in a fast-paced startup environment. Desirable Experiences FDA Submissions: Direct experience leading or supporting FDA submissions for medical devices.​ Neurological Conditions: Knowledge of epilepsy or other neurological conditions​ Digital Biomarkers : Experience with software as a medical device (SaMD) and other digital tools.​ Health Economics: Understanding of health economics outcomes research and reimbursement pathway development, including CPT code processes.​ StartUp Experience: Ability to thrive in fast-paced, innovative startup environments and to maximise the impact of limited resources.​ Network : Established relationships within clinical research, regulatory affairs and digital health communities.​ Professional Development : Relevant certifications such as ACRP, SOCRA or similar professional qualifications.​ What we can offer A key leadership role with the opportunity to actively shape the development of a rapidly growing digital MedTech company looking to make a huge positive impact on the world.​ A flexible working model that enables you to work when you are most productive.​ A competitive salary of £60-80K plus performance bonus. Company Pension Scheme (you contribute 2% and the company 7% on qualifying earnings).​ A dynamic and collaborative environment, where curiosity and innovation are encouraged and rewarded.​ A diverse and highly experienced team combining scientific, technical and commercial expertise.​ Key leadership role with the opportunity to actively shape the development of Neuronostics.​ 25 days annual leave, plus public/bank holidays. Staff members also receive an additional day off to celebrate their birthday.​ Access to ongoing professional development.​ Regular staff events and company away days.​ ​ We operate a hybrid working model, blending time in the office with working from home. Please note that as a key leadership role in our rapidly growing company, regular time in our Bristol offices will be expected: our senior team lead by example. The Engine Shed is located right outside Bristol Temple Meads. How to apply Applicants are encouraged to get in touch early for an informal chat about the role. Contact to arrange this ​ ​ When you are ready to apply, you should submit an application consisting of a CV and accompanying cover letter outlining how your skills, experience and future career plans align with what we are looking to ​ ​ Applicants will be considered on a rolling basis until the position is filled.