Director of Clinical Affairs
$150,000–$180,000 year
RemoteUnited States or Boston, Massachusetts, United States
Job Summary
Own clinical strategy end-to-end by translating 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 while driving global KOL engagement and building scalable clinical operations. As the first Clinical hire in the US, you will lead a team covering both US & Europe, reporting directly to the CEO. This role requires 8+ years of experience in Clinical Affairs at a medical-device company, ideally in AI/SaMD, with a strong background in MFM/OBGYN and clinical study design.
Required Qualifications
- 8+ years of experience in Clinical Affairs at a medical-device company
- Strong technical/scientific background with ability to analyze/understand/assess technical, clinical, or scientific results
- Strong background in MFM / OBGYN / prenatal medicine
- 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
- Interest in our mission is critical
Desired Qualifications
- ideally in AI / SaMD
- healthtech scale-up experience
- credble transferability
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