Director of Clinical Affairs

Sonio • Boston, MA

6d • $150,000 - $180,000 • Remote

About The Position

Sonio is seeking a Director of Clinical Affairs to lead their clinical team covering both US & Europe. This role reports directly to the CEO and is part of the Executive Committee (Excom). The primary responsibilities include owning the end-to-end clinical strategy, managing and growing a clinical team, overseeing the clinical budget, and representing Clinical Affairs at Excom. The role also involves owning the clinical case for FDA 510(k) and EU MDR submissions, driving KOL engagement, and building scalable clinical operations.

Requirements

• 8+ 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

Nice To Haves

• Interest in Sonio's mission is critical.

Responsibilities

• 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

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
• 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

What This Job Offers

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