Principal Clinical Scientist - MedTech AI & SaMD Leadership

Health Data Innovations, Inc.; New York (NY); In loco; USD 180.000 - 240.000; Tempo pieno

Descrizione del lavoro

Neko Health is building a future where healthcare stays well through prevention and earlier detection. Our medical devices and AI turn new health measurements into opportunities to improve care, translating rigorous science into practical clinical use.

We are seeking a Principal Clinical Scientist to own the scientific evidence pathway for SaMD, regulatory submissions and validation, collaborating with engineers, data scientists and medical leads to shape product development.

Competenze

• PhD, MD or equivalent doctoral qualification in a clinical, scientific or quantitative field.
• Strong medical and physiological understanding with ability to link device data to disease processes.
• Demonstrated leadership of clinical studies from design to reporting.
• Strong quantitative judgement and awareness of AI validation pitfalls.
• Hands‑on fluency with AI and data, including Python or R.
• Understanding regulatory pathways (FDA, MHRA, EU MDR) and ethics considerations.
• Experience in fast‑moving product environments with independent decision making.
• Clear communication across scientific, clinical, technical and executive audiences.

Mansioni

• Take ownership of active programmes and assess technology and evidence.
• Build efficient evidence plans with milestones aligned to regulatory needs.
• Move studies into execution with proper populations and endpoints.
• Shape development by guiding data collection and linking measurements to practice.
• Turn results into recommendations on progress or changes.
• Deliver evidence packages for regulatory submissions.

Conoscenze

Medical knowledge

AI & data fluency

Quantitative judgement

Communication

Clinical study leadership

Regulatory understanding

Formazione

PhD/MD or equivalent

Strumenti

Python

R

Descrizione del lavoro

Neko Health is building a future where healthcare stays well through prevention and earlier detection. Our medical devices and AI turn new health measurements into opportunities to improve care, translating rigorous science into practical clinical use.

We are seeking a Principal Clinical Scientist to own the scientific evidence pathway for SaMD, regulatory submissions and validation, collaborating with engineers, data scientists and medical leads to shape product development.