Director of Clinical Affairs

About Sonio Each year, 140M children are born. Birth defects affect 1 in 33 births in developed countries, and in 50% of cases, they are not detected during prenatal examinations. Prenatal medicine is particularly complex, and the scans impose heavy responsibilities on healthcare professionals. They can also be a source of stress for future parents. Each year, 140M children are born. Birth defects affect 1 in 33 births in developed countries, and in 50% of cases, they are not detected during prenatal examinations. Prenatal medicine is particularly complex, and the scans impose heavy responsibilities on healthcare professionals. They can also be a source of stress for future parents. Resulting from 5 years of collaboration between world-renowned experts from Necker Hospital and Ecole Polytechnique, Sonio uses artificial intelligence to improve prenatal screening and diagnosis. Based on patented algorithms and a proprietary expert database, Sonio aims to become the reference tool to help practitioners improve screening, reduce diagnostic errors, and optimize pregnant women’s medical path. Sonio's mission is to improve women's and children's health by promoting access and quality of care through technological innovation, medical expertise, and collective intelligence. About The Role You'll be the first Clinical hire in the US, leading a team covering both US & Europe. You'll directly report to the CEO and sit at the Excom. Your main missions are: 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 About The Profile Sonio is a mission-driven company, so interest in our mission is critical. Other requirements are: 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 Location: Ideally Boston, remote can be considered for the right candidate Salary: $180k - $200k + 10% bonus Sonio's Benefits Health Insurance (Medical plan, vision, dental) - up to 30,000$ 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, specifically unlimited access to coaching We move fast and aspire to be transparent over the process - our objective is that the process from the first chat to an offer is no longer than a month. We also aspire to give an answer to every application in a week - if you have not heard from us, please follow up at View email address on click.appcast.io. You'll Be The First Clinical Hire In The US, Leading a Team Covering Both US & Europe. You'll Directly Report To The CEO And Sit At The Excom. Your Main Missions Are: 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 About The Profile Sonio is a mission-driven company, so interest in our mission is critical. Other requirements are: 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 Location: Ideally Boston, remote can be considered for the right candidate Salary: $180k - $200k + 10% bonus Sonio's Benefits Health Insurance (Medical plan, vision, dental) - up to 30,000$ 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, specifically unlimited access to coaching We move fast and aspire to be transparent over the process - our objective is that the process from the first chat to an offer is no longer than a month. We also aspire to give an answer to every application in a week - if you have not heard from us, please follow up at View email address on click.appcast.io. #J-18808-Ljbffr OneRagtime