Principal Clinical Scientist, Medical Devices & AI

Neko Health•New York, NY

3d•$202,500 - $247,500•Remote

About The Position

Neko is hiring a Principal Clinical Scientist to set the scientific direction for generating evidence for medical devices, AI algorithms, and software as a medical device (SaMD). The role turns product bets—such as new sensors or models—into testable hypotheses, evidence plans, and rigorous study protocols that can support products launched in Neko’s clinics as quickly as the science allows. This is a senior scientific leadership role for a first-principles, AI-fluent researcher rather than a clinical operations lead. The scientist designs novel studies where no template exists, uses AI throughout study design and analysis, and works with regulatory and ethics requirements so studies can be reviewed efficiently and produce useful evidence. Neko’s products are designed for its own clinics, so study plans should reflect its clinic operations, member journey, and safeguards. The role also establishes methodological standards, mentors researchers, and ensures that data, methods, and templates from studies can be reused. The position partners closely with product, engineering, data science, clinical operations, regulatory, and quality teams. Regulatory and quality teams own submissions and strategy; this role owns the scientific study design and evidence generation. It is not an academic, regulatory-affairs, study-management, or monitoring role. The position is remote-eligible within New York, New Jersey, Connecticut, Florida, California, and Washington, DC, where Neko Health currently employs team members.

Requirements

MD, PhD, or equivalent doctoral-level training in a relevant field such as clinical research, epidemiology, physiology, biomedical engineering, biostatistics, or medical AI.
At least 8 years of experience designing and leading clinical or validation studies, including at least 4 years in medical devices, diagnostics, digital health, or AI/SaMD.
A record of taking a new idea through evidence generation that informed a product, regulatory submission, or clinical decision.
Hands-on fluency with AI and data, including working in Python or R and understanding how modern machine-learning and foundation models are built and evaluated.
Regular use of large language models in daily work.
Good working understanding of how evidence maps to regulatory and ethics pathways, such as FDA, EU MDR, ISO 14155, and UK MHRA; regulatory affairs expertise is not central to the role.
Strong quantitative judgment, including the ability to specify and defend sample sizes, endpoints, reference standards, and analysis plans, and to recognize common pitfalls in diagnostic-accuracy and AI-validation studies.
Experience in, and a clear preference for, a fast, product-led environment such as a technology company, medtech scale-up, or applied research lab.
Remote eligibility is limited to New York, New Jersey, Connecticut, Florida, California, and Washington, DC.

Nice To Haves

Experience with physiological sensing, imaging, or multimodal biomarker and AI validation.
Experience running prospective studies across multiple sites or countries, including in Europe and the US.
Experience mentoring scientists earlier in their careers.
Publications and a clear perspective on which publications matter for the product.

Responsibilities

Translate product bets and intended member impact into testable hypotheses, evidence plans, and rigorous study protocols.
Identify the shortest credible route from an anchor use case to a product that can launch in Neko clinics.
Design novel, rigorous studies when no established template exists, finding ways to obtain reliable answers quickly.
Use AI as a core part of study design and analysis, and evaluate AI models appropriately.
Design studies with working knowledge of regulatory and ethics requirements, generating evidence that regulatory colleagues can use and, where appropriate, serve multiple needs with one study.
Account for Neko’s clinics, member journey, and safeguards when designing studies for products intended for those clinics.
Ensure studies leave reusable data, methods, or templates.
Review and challenge study designs from partners, universities, vendors, and internal teams; establish methodological standards and mentor earlier-career scientists.
Partner with product, engineering, data science, clinical operations, regulatory, and quality teams, advising them before they commit to studies.
Generate evidence that supports clear go/no-go decisions and timely product launches in Neko clinics.