Director of Clinical Affairs
SonioPrenatal Screening company
Boston, United States$180K - $200KDirector
Bpifrance
Cross Border Impact Ventures
Elaia
OneRagtime
EIC Fund (European Innovation Council)
EASME - EU Executive Agency for SMEs
Product
About the role
TL;DR
Director of Clinical Affairs to lead clinical strategy and team for AI-powered prenatal screening.
- •Sonio is seeking a Director of Clinical Affairs to lead their clinical strategy and team across the US and Europe.
- •This role reports directly to the CEO and is part of the Executive Committee.
- •Key Responsibilities Own clinical strategy end-to-end, translating priorities into a roadmap of studies, claims, KOLs, and communication.
- •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, in partnership with RAQA.
- •Drive KOL engagement and medical knowledge diffusion worldwide.
- •Build scalable, repeatable clinical operations.
- •Requirements 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, Good Clinical Practice, and biostatistics fundamentals.
- •Proven experience partnering with RAQA on FDA 510(k) and EU MDR submissions.
Required skills
Product ManagementStrategic PlanningProduct StrategyGo-to-MarketFeature PrioritizationProduct AnalyticsCompetitive AnalysisProduct Operations
Domain expertise
healthtechai
Benefits & perks
Health Insurance (Medical plan, vision, dental), FSA & HSA, 401(k) match, Life Insurance, Parental Policy, PTO, Flexible hours, Remote policies, Commuter Benefits, Ongoing trainings, Coaching
Tech stack
PythonJavaScriptTypeScriptSQLBashReactNode.jsDjangoFlaskFastAPISpringExpressRuby on Rails.NETASP.NETNestJSLaravelSymfonyGinEchoActixPhoenixMicroservicesPandasNumPySparkAirflowdbtTableauPower BI