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.

Principal Clinical Scientist, Medical Devices & AI at Neko Health | JobZoey