Director of Clinical Affairs
Core
Lead end-to-end execution of regulatory-driven clinical studies for FDA-regulated medical devices and SaMD to support clearance and market launch.
Role type
Director of Clinical Affairs (hands-on IC)
Builds
Clinical studies leading to FDA 510(k), De Novo, or PMA clearances for sleep fitness hardware and software.
Domain
Medical Devices / Digital Health (SaMD) / Sleep Technology
Deliverable
production ML models | product features
Required skills
Clinical study design and execution, IRB/Ethics submission management, Third-party site selection and oversight, Clinical data management (eCRF, query resolution), FDA device regulations fluency (IDE, De Novo, 510(k)), Cross-functional program management, Vendor/CRO management, Budgeting and risk mitigation, KOL relationship cultivation.
Preferred skills
Advanced degree (MS, MPH, PhD, or clinical doctorate), ACRP or SOCRA certification, Experience with biosensing devices or consumer health tech, Real-world evidence (RWE) study design, Decentralized/hybrid trial models.
Technologies
eCRF systems, Clinical trial management systems (implied), FDA submission platforms
Responsibilities
Lead study design with internal teams and KOLs; Own execution from protocol to final report; Write and manage IRB submissions and informed consent forms; Select and oversee clinical sites and investigators; Manage clinical data operations and vendor coordination; Develop SOPs and scale clinical operations function; Support regulatory interactions and submissions.
Seniority
Director, hands-on leadership
