Director of Clinical Affairs

About the role

Sonio is seeking its first US Clinical hire to lead a cross‑continental team that shapes the clinical strategy for AI‑driven prenatal screening solutions. Reporting directly to the CEO and sitting on the Executive Committee, you will translate executive priorities into actionable study roadmaps, regulatory submissions, and global KOL engagement.

Key responsibilities

• Define and own the end‑to‑end clinical strategy, converting Excom goals into study plans, claims, and communication tactics in partnership with the CSO.
• Prioritise clinical initiatives across Development, RAQA, Marketing and Operations, ensuring alignment with business objectives.
• Build, manage, and grow a 3‑person clinical team while overseeing the clinical budget.
• Lead the clinical justification for FDA 510(k) and EU MDR submissions, collaborating closely with RAQA.
• Drive worldwide KOL engagement and disseminate medical knowledge.
• Establish scalable, repeatable clinical operations to support product launch and post‑market activities.

Required profile

• 12+ years in Clinical Affairs within a medical‑device company, preferably AI‑based SaMD.
• Strong scientific background with the ability to evaluate technical and clinical data.
• Deep experience in maternal‑fetal medicine, obstetrics, or demonstrable transferability.
• Proven track record of partnering with RAQA on FDA 510(k) and EU MDR submissions.
• Experience scaling health‑tech teams in a fast‑growing environment.
• Business acumen to balance scientific, product, go‑to‑market, and regulatory priorities at the executive level.

Required skills

• FDA 510(k) submission process
• EU MDR submission process
• Clinical study design (validation, post‑market, real‑world evidence)
• Good Clinical Practice (GCP) compliance
• Biostatistics fundamentals

What we offer

• Competitive salary $180k‑$200k per year plus 10% bonus
• Health, vision, and dental insurance up to $30,000 annually
• 401(k) with up to 4% employer match
• Life insurance coverage up to 2× salary (max $200k)
• Generous parental leave for primary and secondary caregivers
• 20 days PTO plus an additional week between Christmas and New Year
• Flexible work arrangement – Boston‑based with remote options for the right candidate