Director of Clinical Affairs

OneRagtime; Boston (MA); On-site; USD 180,000 - 200,000; Full time

Benefits offered by this job

Health Insurance (Medical plan, vision

401(k)

Life Insurance

Parental Policy

PTO

Offices in Boston & New York

Flexible hours & remote policies

Commuter Benefits

Offsite in France & team events

Coaching & development

Job summary

Sonio is a mission-driven medical AI company seeking its first US Clinical Affairs hire, reporting to the CEO and sitting on the Excom. You will own the clinical strategy end-to-end and translate executive priorities into a studies roadmap with RAQA, DS, and Marketing teams.

Based in Boston with remote flexibility, you will build a 3-person team, manage the clinical budget, and drive global KOL engagement, while ensuring regulatory submissions and high standards of clinical practice.

Qualifications

• 12+ years in Clinical Affairs at a medical-device firm.
• Experience with AI / SaMD and healthtech scale-ups.
• Strong background in MFM / OBGYN / prenatal medicine.
• Knowledge of validation, post-market, and real-world evidence.
• Proven collaboration with RAQA on FDA 510(k) and EU MDR.

Responsibilities

• Own clinical strategy end-to-end and roadmap with CSO.
• Manage a 3-person clinical team and budget.
• Lead FDA 510(k) and EU MDR submissions with RAQA.
• Drive KOL engagement and medical knowledge diffusion.
• Build scalable, repeatable clinical operations worldwide.

Skills

Clinical Affairs

AI SaMD

Healthcare

Clinical study design

RAQA liaison

Team leadership

Job description

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 [e-mail].

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 [e-mail].