Director of Clinical Affairs

The role

You will lead a clinical team covering the US and Europe and report to the CEO. You will own the clinical strategy, manage the clinical budget, and drive KOL engagement.

What you will do

• Own clinical strategy end-to-end
• Translate Excom priorities into a roadmap of studies, claims, KOLs and communication
• 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, with RAQA
• Drive KOL engagement and medical knowledge diffusion worldwide
• Build scalable, repeatable clinical operation

Required qualifications

• 12+ years of experience in Clinical Affairs at a medical-device company
• 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
• Interest in our mission is critical

Nice to have

• ideally in AI / SaMD
• healthtech scale-up experience

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

About the company

Sonio uses artificial intelligence to improve prenatal screening and diagnosis. The company aims to improve women's and children's health through technological innovation, medical expertise, and collective intelligence.