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Director of Clinical Affairs
SonioLead Clinical Affairs in Boston for AI-based prenatal health technology. Manage clinical strategy and a team to optimize screening and diagnostics across the US and Europe.
Posted 7/29/2026full-timeBoston • Massachusetts • 🇺🇸 United StatesLead💰 $180,000 - $200,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in Clinical Affairs, particularly in managing clinical strategies, FDA 510(k) and EU MDR submissions, and leading clinical teams. Possesses strong analytical skills in clinical study design and a deep understanding of regulatory requirements for AI-based medical devices.
Highest-signal resume keywords
Clinical Strategy OwnershipFDA 510(k) SubmissionsEU MDR SubmissionsClinical Study DesignTeam Management
ATS Keywords
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Hard Skills
Clinical AffairsClinical Study DesignGood Clinical PracticeBiostatistics FundamentalsRegulatory AffairsTechnical AnalysisAI / SaMD KnowledgeKOL EngagementBudget ManagementHealthtech Experience
Soft Skills
Team LeadershipBusiness AcumenInterdepartmental CollaborationAnalytical ThinkingCommunication Skills
Industry Keywords
Medical DeviceMFMOBGYNPrenatal MedicineReal-World EvidenceClinical ValidationHealthtech Scale-UpExcom EngagementClinical OperationsKOLs
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- 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
Benefits
Comp & perks- 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