Principal Clinical Scientist, Medical Devices & AI

Mission Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk. Our mission: make data-driven, preventative care accessible to more people, before symptoms appear.

In a single, non-invasive visit under an hour, proprietary technology and direct clinical care combine to deliver personalised, actionable insights. It's a team that thinks in 10x, not 10%. Every role here plays a part in building a world where prevention is the norm, and where your work genuinely helps people live longer, healthier lives.

Role Purpose Neko is building the most complete, longitudinal picture of human health ever assembled, and we design our own sensors, algorithms and clinical workflows to do it. Evidence is how those bets become products. This role sets the scientific direction for how we generate that evidence for devices, AI algorithms and software as a medical device (SaMD). Leadership sets the strategy and places the bold bets, often a new sensor or a model that does not exist yet. Your job is to turn each one into the study, or series of studies, that gets us to a product we can launch in our clinics, as fast as the science allows. We are looking for a scientist in the mold of a frontier-lab researcher rather than a clinical operations lead: someone who works from first principles, is fluent in AI, and treats process as a tool to be understood and used, not a constraint to be obeyed. You will also be a senior scientific leader and mentor for the researchers around you. What You’ll Do

• Turn bets into studies, and studies into products. Take an anchor use case and the member impact it is meant to deliver, and work out the shortest credible route to a launchable product. Turn it into a testable hypothesis, an evidence plan and a protocol that stands up to scrutiny.

• Find a way when there is no template. Where nothing has been done before, design the study that has not been run, and find creative, rigorous ways to get a reliable answer quickly.

• Be AI-native. Use AI as a core part of how you work, from study design to analysis, and understand how to evaluate AI models properly.

• Work well with regulatory. Understand regulation and ethics well enough to design studies that clear review quickly and produce evidence regulatory colleagues can use, with one study serving several needs. Regulatory and quality own submissions and strategy; you make sure the science gives them what they need.

• Design for our clinics. Understand how Neko operates: our clinics, the member journey and the safeguards we can build around a new measurement. We are building products for our own clinics, not for sale in other markets, and studies should be designed accordingly.

• Make data and methods compound. Make sure every study leaves something reusable behind, whether data, methods or templates.

• Raise the bar. Challenge designs from partners, universities and vendors, and from inside Neko. Set the methodological standard for the team and mentor earlier-career scientists.

• Partner closely. Work side by side with product, engineering, data science, clinical operations, regulatory and quality, and be the person they come to before committing to a study.

What Success Looks Like

• Bets reach a clear go or no-go on the evidence, and the ones that work are launched in our clinics quickly.

• Protocols are approved quickly and answer the question they were designed to answer, with few avoidable amendments.

• Evidence generated once is used for product, regulatory and scientific purposes.

• The scientists around you are visibly stronger, and the team’s study design is better than when you arrived.

Minimum Requirements

• MD, PhD or equivalent doctoral-level training in a relevant field (clinical research, epidemiology, physiology, biomedical engineering, biostatistics, medical AI or similar).

• At least 8 years of experience designing and leading clinical or validation studies, including at least 4 years on medical devices, diagnostics, digital health or AI/SaMD.

• A record of taking something new from idea to evidence that was used in a product, a regulatory submission or a clinical decision.

• Hands-on fluency with AI and data: you work in Python or R, understand how modern ML and foundation models are built and evaluated, and already use large language models in your daily work.

• Good working understanding of how evidence maps to regulatory and ethics pathways (for example FDA, EU MDR and ISO 14155, UK MHRA). Regulatory affairs expertise is not the core of the role.

• Strong quantitative judgement: you can specify and defend a sample size, endpoint, reference standard and analysis plan, and you know where diagnostic-accuracy and AI validation studies go wrong.

• Experience in a fast, product-led environment such as a technology company, medtech scale-up or applied research lab, and a clear preference for it.

• Remote-eligible within NY, NJ, CT, FL, CA, and Washington, DC, the locations where Neko Health currently employs team members.

Preferred

• Experience with physiological sensing, imaging or multimodal biomarker and AI validation.

• Experience running prospective studies across several sites or countries, including in Europe and the US.

• Experience mentoring scientists earlier in their careers.

• Publications, and a clear view of which ones matter for the product and which do not.

What This Role Is Not

• Not an academic post. Publications are a by-product, not the goal.

• Not a strategy or regulatory affairs role. Leadership sets the bets, regulatory owns submissions; you own turning bets into studies that deliver product.

• Not a study-management or monitoring role. You own the science and the design; others run operations.

• Not a role for someone who needs a CRO, a steering committee and a long runway to start. We move quickly and accept calculated risk, but the science has to hold up.