Director of Clinical Affairs

Join Sonio, a mission-driven company focused on improving women's and children's health through technological innovation. As the Director of Clinical Affairs, you will lead a team covering both the US and Europe, manage the clinical budget, and drive KOL engagement. You will have a strong background in clinical affairs, particularly in prenatal medicine, and experience with FDA 510(k) and EU MDR submissions. The position is ideally based in Boston, with remote options available for the right candidate.

• Own clinical strategy end-to-end — translate Excom priorities into a roadmap of studies, claims, KOLs and communication, in partnership with the CSO.
• 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.