Neko Health
Principal Clinical Scientist, Medical Devices & AI
New York, Remote. Posted 10 days ago
The role
The Principal Clinical Scientist will own the scientific evidence pathway for medical devices, AI algorithms, and Software as a Medical Device. This role involves designing and executing studies, analyzing data, and delivering evidence for regulatory submissions.
What you will do
- Take ownership of active R&D programmes.
- Build efficient evidence plans and define study milestones.
- Develop and refine protocols with appropriate populations and endpoints.
- Guide prototyping and data collection with engineering and data science teams.
- Deliver analyses and scientific reports from datasets and studies.
- Deliver evidence for regulatory review and address gaps in clinical evidence packages.
- Use AI tools to accelerate research and scientific writing.
- Mentor colleagues and establish reusable methods.
Required qualifications
- PhD, MD or equivalent doctoral qualification in a relevant clinical, scientific or quantitative discipline.
- Strong medical and physiological understanding.
- Demonstrated scientific leadership of clinical studies from design through reporting.
- Strong quantitative judgement regarding sample sizes, endpoints, and analysis plans.
- Practical proficiency in Python or R.
- Understanding of how modern machine learning and foundation models are developed and evaluated.
- Regular use of large language models in work.
- Working understanding of FDA and UK MHRA requirements, EU MDR and ISO 14155.
- Experience in a fast-moving, product-led environment.
- Clear communication with scientific, clinical, technical and executive audiences.
Nice to have
- Experience developing and validating medical devices, diagnostics or medical AI.
- Experience with physiological sensing, medical imaging, novel biomarkers or multimodal diagnostic technologies.
- Experience with clinical studies across multiple sites or countries.
- Experience mentoring scientists and building productive collaborations with academic and clinical partners.
About the company
Neko Health aims to make data-driven, preventative care accessible through proprietary technology and direct clinical care.