Principal Clinical Scientist, MedTech AI & SaMD

Neko Health AB; Washington (District of Columbia); In loco; USD 203.000 - 248.000; Tempo pieno

Descrizione del lavoro

Neko Health AB is seeking a Principal Clinical Scientist to own the scientific evidence pathway for medical devices, SaMD, and AI algorithms. You will design pragmatic studies, lead clinical investigations, and work with regulatory affairs to support submissions.

You will collaborate with engineers, data scientists, medical leads and operations to translate findings into clinical use, drive evidence generation, and mentor teammates in a fast-moving, product-led environment.

Competenze

• PhD, MD or equivalent doctoral qualification in a relevant clinical, scientific or quantitative discipline.
• Strong understanding of clinical studies, study design and endpoints.
• Experience leading clinical studies from protocol through reporting and regulatory support.
• Familiarity with diagnostic AI validation, data leakage and study pitfalls.

Mansioni

• Take ownership of active programmes and assess technology, clinical use cases and evidence across R&D programmes.
• Build clear evidence plans with milestones aligned to regulatory needs.
• Move studies into execution with appropriate populations, endpoints and reference standards.
• Shape development by guiding data collection and connecting measurements to clinical use.
• Deliver analyses and reports from existing datasets and new studies; make recommendations.
• Support regulatory submissions by providing robust scientific content and addressing gaps.

Conoscenze

Medical knowledge

AI & data

Study design

Statistical analysis

Regulatory awareness

Python/R

Team leadership

Formazione

PhD or MD

Strumenti

Python

R

Descrizione del lavoro

Neko Health AB is seeking a Principal Clinical Scientist to own the scientific evidence pathway for medical devices, SaMD, and AI algorithms. You will design pragmatic studies, lead clinical investigations, and work with regulatory affairs to support submissions.

You will collaborate with engineers, data scientists, medical leads and operations to translate findings into clinical use, drive evidence generation, and mentor teammates in a fast-moving, product-led environment.