Director of Clinical Affairs

What this role involves

Eight Sleep is hiring a Director of Clinical Affairs to lead regulatory-driven clinical studies for their sleep fitness products. The role involves end-to-end study execution, including protocol development, IRB submissions, site management, data operations, and FDA compliance. The position requires deep regulatory knowledge and hands-on operational experience.

Skills this posting asks for

• clinical study design
• protocol development
• irb submissions
• informed consent forms
• data management
• crf/ecrf design
• fda regulations
• ich-gcp
• iso 14155
• samd guidance
• cro management
• vendor management
• budget management
• risk mitigation
• site selection
• enrollment management
• monitoring
• study close-out
• regulatory submissions
• audits

Requirements

• Level: director

From the employer’s posting

JOIN THE SLEEP FITNESS MOVEMENT At Eight Sleep, we're on a mission to fuel human potential through optimal sleep. As the world's first sleep fitness company, we're redefining what it means to be well-rested and building the most advanced hardware, software, and AI technology to make it possible. O…