Director of Clinical Affairs Job Boston area,Massachusetts USA,Management

Sonio Clinical Leader

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:

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 careers.