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Director of Clinical Affairs

Sonio· R&D
Apply on company site
Hybrid (Boston)$200k - $220kFull-timePosted 2mo ago

About the role

Senior leadership role leading clinical strategy and operations for Sonio in the US and Europe, reporting to the CEO and sitting on Excom; responsible for end-to-end clinical roadmap, team management, regulatory submissions, KOL engagement, and scalable clinical operations.

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

Qualifications

  • 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

Skills

Required:Clinical strategy developmentRegulatory submissions (FDA 510(k), EU MDR)KOL engagementTeam management

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, unlimited access to coaching
Last updated Sep 30, 2026. Interested? Apply on the company site.

About Sonio

Ultrasound and clinical workflows made easy with AI

Sonio is a cloud-based ultrasound OB-GYN reporting software using clinical AI* to bring efficiency and quality control to your practice’s workflow.

UltrasoundOB-GYNClinical WorkflowsAI
Company profileWebsite

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