Director of Clinical Affairs

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 womens medical path.

Sonios mission is to improve womens and childrens health by promoting access and quality of care through technological innovation medical expertise and collective intelligence.

About the role

Youll be the first Clinical hire in the US leading a team covering both US & Europe. Youll 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

Sonios Benefits

Health Insurance (Medical plan vision dental) - up to 30000$ 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

Required Experience:

Director