Director of Clinical Affairs

Sonio
Boston
Workplace: HybridFull timeUSD 180,000 - 200,000 annuallyFunction: Executive & General ManagementExperience: 12+ yearsSkills: ["Leadership","Strategic planning","Technical/scientific analysis","Cross-functional collaboration","Budget management"]

Lead Sonio’s clinical function as the first Clinical hire in the US, reporting to the CEO and sitting on the Excom. Own clinical strategy end-to-end—turn Excom priorities into study and claims roadmaps, arbitrate priorities across DS, RAQA, Marketing, and Ops, and manage a 3-person team and clinical budget. Drive FDA 510(k) and EU MDR submissions with RAQA, grow KOL engagement, and build scalable clinical operations across US and Europe.

Loading

Loading job details...

Preparing the role view and application actions.

FursaFursa
Sonio
Sonio
1 month ago

Director of Clinical Affairs

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI
Last checked: 23 minutes agoStatus: Live

Job Summary

Lead Sonio’s clinical function as the first Clinical hire in the US, reporting to the CEO and sitting on the Excom. Own clinical strategy end-to-end—turn Excom priorities into study and claims roadmaps, arbitrate priorities across DS, RAQA, Marketing, and Ops, and manage a 3-person team and clinical budget. Drive FDA 510(k) and EU MDR submissions with RAQA, grow KOL engagement, and build scalable clinical operations across US and Europe.
Location: Boston
Workplace: Hybrid
Employment Type: Full time
Job Function: Executive & General Management
Seniority: Director level

Key Responsibilities

  • •Own clinical strategy end-to-end by translating Excom priorities into studies, claims, KOLs, and communication roadmaps, in partnership with the CSO.
  • •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 across US and Europe.

Pay and Benefits

Salary: USD 180,000 - 200,000 annually
Perks:Health Insurance401kLife InsuranceParental LeavePaid Leave

Key Requirements

  • •12+ years of experience in Clinical Affairs at a medical-device company, ideally in AI/SaMD and healthtech scale-up experience.
  • •Strong technical/scientific background to analyze and assess technical, clinical, or scientific results.
  • •Strong clinical 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, including clinical-validation requirements for AI-based medical devices.
Experience:12+ yearsMedical devicesAI/SaMDHealthtechHealthcare
Skills:LeadershipStrategic planningTechnical/scientific analysisCross-functional collaborationBudget management
Tech Stack:AISaMDFDA 510(k)EU MDRRWEGood Clinical PracticeBiostatisticsKOL engagement

Company Brief

Sonio
Develops an AI-powered prenatal care platform offering fetal ultrasound analysis and clinical decision support to clinicians and expectant parents, aiming to improve anomaly detection, streamline obstetric workflows, and enhance prenatal outcomes.
Industry: HealthTech
Website