Fall asleep faster and stay asleep longer with personalized cooling and heating for each side of the bed. Pod 6 reduces snoring and works with any mattress. Backed by General Catalyst, Khosla and Y Combinator.
About the role
We're looking for a Director of Clinical Affairs who will own the end-to-end execution of our regulatory-driven clinical studies. This is a hands-on, operationally intense position for someone who knows how to stand up a study from scratch, manage third-party clinical sites, write IRB and informed consent documents, oversee data management, establish and oversee any study committees (EC, DSMB, etc.), prepare for FDA submissions and audits, and drive studies to completion on time and on budget.
What they're looking for
- Track record of leadership or critical participation in trial(s) that led to new FDA clearances/approvals or meaningful labeling expansions for existing products
- Demonstrated experience managing third-party clinical sites , including site selection, activation, monitoring, and close-out
- Proven ability to author IRB/Ethics submissions, informed consent forms, and clinical protocols
- 7+ years experience of cross-functional program management , involving clinical, engineering, and regulatory teams
- Strong working knowledge of clinical data management — eCRF design, data cleaning, query management, and database lock processes
- Fluency in FDA device regulations (IDE, De Novo, 510(k) clinical requirements), ICH-GCP , ISO 14155 , and familiarity with SaMD-specific guidance (e.g., FDA Digital Health frameworks)
More about this role
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. Our products power peak mental, physical, and emotional performance by transforming every night of sleep into a personalized, data-driven recovery experience. We are trusted by high performers, professional athletes, and health-conscious consumers in over 30 countries worldwide.
Recognized as one of Fast Company's Most Innovative Companies in 2019, 2022, 2023, 2026, and twice named to TIME's "Best Inventions of the Year."
We operate like a high-performance team: fast, focused, and motivated by impact. We don't just ship; we iterate, refine, and obsess over the details that help our members sleep better and wake up stronger.
We operate with intensity because our mission demands it. At Eight Sleep, we bring the same mindset as the world's top performers: focused, relentless, and always pushing to be in the top 1% of our craft. Think Kobe Bryant's mamba mentality, applied to bold ideas, next-gen tech, and flawless...
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