Principal Clinical Scientist, Medical Devices – AI

Neko Health

. Set the scientific direction for evidence generation for devices, AI algorithms and software as a medical device .

Posted 11/4/2026full-timeUnited StatesLead💰 $202,500 - $247,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in designing and leading clinical studies, particularly in medical devices and AI, while ensuring compliance with regulatory standards. Proficient in utilizing AI and data analysis to generate reusable evidence that informs product development and clinical decision-making.

Highest-signal resume keywords

MD, PhD Or Equivalent Doctoral-Level Training8 Years Experience Designing Clinical StudiesFluency With AI And Data AnalysisProficiency In Python Or RUnderstanding Of Regulatory Pathways

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study DesignEvidence GenerationAI Model EvaluationStatistical AnalysisSample Size SpecificationDiagnostic-Accuracy StudiesAI Validation StudiesMethodological StandardsStudy Protocol DevelopmentEvidence Mapping

Soft Skills

MentoringCollaborationCritical ThinkingProblem SolvingCommunication

Tools & Technologies

Large Language ModelsAI AlgorithmsMedical DevicesDigital Health TechnologiesData Science Tools

Industry Keywords

Clinical ResearchEpidemiologyBiomedical EngineeringBiostatisticsMedical AIFDA RegulationsEU MDRISO 14155UK MHRAProspective Studies

Tech Stack

Tools & technologies

Python

About the role

Key responsibilities & impact

Set the scientific direction for evidence generation for devices, AI algorithms and software as a medical device
Translate product bets and member impact goals into testable hypotheses, evidence plans and rigorous study protocols
Design novel studies where no established template exists
Use AI throughout study design and analysis and evaluate AI models properly
Design studies that support regulatory and ethics review and generate reusable evidence
Design studies for Neko clinics, member workflows and safeguards
Ensure each study produces reusable data, methods or templates
Challenge study designs from partners, universities, vendors and internal teams
Set methodological standards and mentor earlier-career scientists
Collaborate with product, engineering, data science, clinical operations, regulatory and quality teams
Drive evidence-based go/no-go decisions and rapid clinic launches
Ensure protocols are approved quickly and answer their intended questions
Enable evidence to serve product, regulatory and scientific purposes

Requirements

What you’ll need

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 used in a product, regulatory submission or clinical decision
Hands-on fluency with AI and data; proficiency in Python or R
Understanding of modern ML and foundation model development and evaluation
Daily use of large language models
Working understanding of evidence mapping to regulatory and ethics pathways, including FDA, EU MDR, ISO 14155 or UK MHRA
Ability to specify and defend sample size, endpoint, reference standard and analysis plan
Experience with diagnostic-accuracy and AI validation studies
Experience in a fast, product-led environment such as a technology company, medtech scale-up or applied research lab
Must live in or plan to relocate to New York, New Jersey, Connecticut, Florida, California or Washington, DC
Preferred: experience with physiological sensing, imaging or multimodal biomarker and AI validation
Preferred: experience running prospective studies across several sites or countries, including Europe and the US
Preferred: experience mentoring earlier-career scientists
Preferred: publications and judgment about their product relevance

Benefits

Comp & perks

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