Director of Clinical Affairs

<p>Join the Eight Sleep movement. We are the world’s first sleep fitness company designing hardware, software, and AI to optimize recovery through sleep. The Director of Clinical Affairs will own end-to-end execution of regulatory-driven clinical studies, stand up studies from scratch, manage third-party sites, write IRB and informed consent documents, oversee data management, and support FDA submissions and audits. This role connects internal teams with external sites, investigators, IRBs, CROs, regulatory agencies, and study subjects, ensuring regulatory requirements for medical devices are met and studies support regulatory submissions.</p><p><strong>What You’ll Do</strong> includes leading study design with internal management and KOLs, owning clinical study execution from protocol through final report, writing IRB submissions and ICFs, overseeing third-party sites and investigators, managing clinical data operations, communicating with sites and subjects, developing study timelines and budgets, ensuring compliance with FDA regulations and ICH-GCP, overseeing CROs and vendors, cross-functional collaboration, participating in regulatory interactions, and building a scalable clinical operations function.</p>