Senior Director, Clinical Affairs — AI/SaMD (Remote)

Sonio; Boston; On-site; PHP 11,076,922 - 12,307,692; Full time

Benefits offered by this job

Health Insurance

401(k) Plan

Life Insurance

Parental Policy

PTO 20 days

Offices in Boston & New York

Flexible hours & remote policies

Commuter Benefits

Team building & coaching

Job summary

Sonio is seeking a Clinical Affairs leader to become the first U.S. clinical hire, reporting to the CEO and sitting on Excom. You will own the clinical roadmap across studies, claims, KOLs and communications, partnering with the CSO to arbitrate priorities across departments.

You will manage a 3-person team, own the clinical budget, and represent Clinical Affairs at Excom, driving FDA 510(k) and EU MDR submissions while expanding medical knowledge globally.

Qualifications

• 12+ years of experience in Clinical Affairs at a medical-device company.
• Strong technical/scientific background to assess results.
• Background in MFM / OBGYN / prenatal medicine (or credible transferability).
• Experience with validation studies, post-market, and RWE.

Responsibilities

• Own clinical strategy end-to-end and translate priorities into a roadmap; arbitrate clinical priorities across DS, RAQA, Marketing and Ops.
• Manage and grow a 3-person clinical team; own the clinical budget; represent Clinical Affairs at Excom.
• Lead FDA 510(k) and EU MDR submissions in collaboration with RAQA.
• Drive KOL engagement and diffusion of medical knowledge worldwide.
• Build scalable, repeatable clinical operations.

Skills

Clinical Affairs

AI / SaMD

Biostatistics

Team leadership

Job description

Sonio is seeking a Clinical Affairs leader to become the first U.S. clinical hire, reporting to the CEO and sitting on Excom. You will own the clinical roadmap across studies, claims, KOLs and communications, partnering with the CSO to arbitrate priorities across departments.

You will manage a 3-person team, own the clinical budget, and represent Clinical Affairs at Excom, driving FDA 510(k) and EU MDR submissions while expanding medical knowledge globally.