- Job type
- Full-time
- Work mode
- Hybrid
- Level
- Director
- Department
- Healthcare
- Experience
- 12+ years experience
- Posted
- Sep 23, 2026
About the role
About the role
You'll be the first Clinical hire in the US, leading a team covering both US & Europe. You'll directly report to the CEO and sit at the Excom. Your main missions are:
- Own clinical strategy end-to-end — translate Excom priorities into a roadmap of studies, claims, KOLs and communication, in partnership with the CSO; arbitrate clinical priorities across DS, RAQA, Marketing and Ops
- Manage and grow a 3-person clinical team, own the clinical budget, and represent Clinical Affairs at Excom
- Own the clinical case for FDA 510(k) and EU MDR submissions, with RAQA
- Drive KOL engagement and medical knowledge diffusion worldwide
- Build scalable, repeatable clinical operation
About the profile
Sonio is a mission-driven company, so interest in our mission is critical. Other requirements are:
- 12+ years of experience in Clinical Affairs at a medical-device company, ideally in AI / SaMD; healthtech scale-up experience
- Strong technical/scientific background with ability to analyze/understand/assess technical, clinical, or scientific results
- Strong background in MFM / OBGYN / prenatal medicine (or credible transferability)
- Deep familiarity with clinical study design (validation, post-market, RWE), Good Clinical Practice, biostatistics fundamentals
- Proven experience partnering with RAQA on FDA 510(k) and EU MDR submissions; understands clinical-validation requirements for AI-based medical devices
- Strong experience managing team with both challenge & care
- Business acumen: comfortable arbitrating between science, product, GTM and regulatory priorities at Excom level
Sonio's Benefits
⚕️Health Insurance (Medical plan, vision, dental) - up to 30,000$ per year + FSA & HSA 👵 401(k) - up 4% of your salary matched ⛑️ Life Insurance - covering 2 times your salary, up to $200k 🐣 An attractive Parental Policy for primary and secondary caregivers 🏝️ 20 PTO + 1 week offered between Christmas and New Year 🖥️ Offices in Boston (HQ) & New York (incl. free breakfast, drinks & gym) ⏰ Flexible hours & remote policies 🚎 Commuter Benefits ✈️ One offsite per year in France & regular team building with US team 🚀 Ongoing trainings and continuous opportunities for professional growth and development, specifically unlimited access to coaching