Director of Clinical Affairs

Sonio • Boston, MA

4d • Hybrid

About The Position

Sonio is a mission-driven company focused on improving prenatal screening and diagnosis through artificial intelligence. Founded on collaboration between experts from Necker Hospital and Ecole Polytechnique, Sonio utilizes patented algorithms and a proprietary expert database to become a reference tool for practitioners. The company aims to enhance screening, reduce diagnostic errors, and optimize the medical journey for pregnant women. Sonio's mission is to advance women's and children's health by increasing access to quality care through technological innovation, medical expertise, and collective intelligence. This role is the first Clinical hire in the US, leading a team covering both US & Europe. The Director will report directly to the CEO and be part of the Executive Committee (Excom).

Requirements

• 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 the 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, and biostatistics fundamentals.
• Proven experience partnering with RAQA on FDA 510(k) and EU MDR submissions.
• Understanding of clinical validation requirements for AI-based medical devices.
• Strong experience managing a team with both challenge and care.
• Business acumen: comfortable arbitrating between science, product, GTM, and regulatory priorities at Excom level.
• Interest in Sonio's mission is critical.

Responsibilities

• Own clinical strategy end-to-end, translating 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.
• Represent Clinical Affairs at Excom.
• Own the clinical case for FDA 510(k) and EU MDR submissions, in collaboration with RAQA.
• Drive KOL engagement and medical knowledge diffusion worldwide.
• Build scalable, repeatable clinical operations.

Benefits

• Health Insurance (Medical plan, vision, dental) - up to $30,000 per year
• FSA & HSA
• 401(k) - up to 4% of your salary matched
• Life Insurance - covering 2 times your salary, up to $200k
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed