Principal Clinical Scientist, Medical Devices & AI

Neko Health•New York, NY

About The Position

Neko Health is seeking a Principal Clinical Scientist to lead the scientific evidence pathway for medical devices, AI algorithms and Software as a Medical Device (SaMD), from early concepts and prototypes through clinical validation, regulatory submissions and post-launch evaluation. The role joins multiple active R&D programmes and combines scientific leadership with hands-on study design, analysis and interpretation. Working with engineers, data scientists, medical leads, research operations, clinical partners and regulatory affairs, the Principal Clinical Scientist will determine evidence needs, design pragmatic studies, guide product development and clinical use, and deliver evidence for regulatory review. The role also strengthens team practices, uses AI tools to support research and scientific writing, and mentors colleagues.

Requirements

PhD, MD or equivalent doctoral qualification in a relevant clinical, scientific or quantitative discipline; a medical degree is not required.
Strong medical and physiological understanding and the ability to connect device measurements and algorithm outputs to disease processes, clinical pathways and decisions, and assess their clinical relevance.
Demonstrated scientific leadership of clinical studies, with hands-on ownership from study design and protocol development through analysis, interpretation and reporting.
Evidence that prior work informed product development, regulatory submissions or clinical implementation.
Strong quantitative judgment, including the ability to define and defend sample sizes, endpoints, reference standards and analysis plans.
Understanding of common pitfalls in diagnostic accuracy and AI validation studies, including selection bias, data leakage and inappropriate comparators, and how to address them.
Practical proficiency in Python or R, understanding of how modern machine learning and foundation models are developed and evaluated, and regular use of large language models in work.
Working understanding of evidence requirements and regulatory and ethics pathways, including FDA and UK MHRA requirements, EU MDR and ISO 14155, with the ability to translate these into suitable study designs in partnership with regulatory affairs specialists.
Experience in a fast-moving, product-led environment such as a technology company, medtech scale-up or applied research lab, and a clear preference for this way of working.
Ability to work independently, prioritize across programmes and make sound scientific decisions under uncertainty.
Clear communication with scientific, clinical, technical and executive audiences, including explaining findings, limitations and implications for development and clinical use.

Nice To Haves

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.

Responsibilities

Assess technology, clinical use cases and existing evidence across priority R&D programmes.
Identify the key questions and decisions relevant to earlier detection, better care and member benefit.
Define evidence plans, studies, milestones and progression criteria aligned with product development and clinical and regulatory needs.
Identify opportunities for studies and datasets to address multiple questions across programmes.
Develop or refine study protocols, including populations, endpoints, reference standards and analytical approaches.
Work with research operations and clinical partners to secure approvals and initiate studies.
Guide prototyping and data collection with engineering, data science and medical leads, connecting measurement performance and algorithm outputs to intended clinical use.
Analyze existing datasets and completed studies, produce scientific reports, investigate unexpected findings and recommend what should progress, change or stop.
Own the scientific content of clinical evidence packages for regulatory submissions, working with regulatory affairs to address evidence gaps, substantiate claims and respond to reviewers.
Use AI tools to accelerate research, analysis and scientific writing while maintaining scientific judgment and accountability.
Mentor colleagues and establish reusable methods to improve the quality and pace of future programmes.