Director of Clinical Affairs

About this role

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. 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.

HIGH STANDARDS. NO APOLOGIES.

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 execution. This isn't a 9-to-5. Our team is deeply committed, often putting in the extra effort — not because we're told to, but because we're invested.

We're here to build fast, push limits, and deliver without compromise. If you thrive under pressure and want to do the most meaningful work of your career, you'll feel right at home. If you're looking for something easier — this isn't it.

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.

You'll be the connective tissue between our internal teams and the external clinical sites, investigators, IRBs, CROs, regulatory agencies, and, when necessary, study subjects directly. You'll bring deep fluency in regulatory requirements for medical devices, and you'll have a track record of delivering clinical studies that have supported regulatory submissions.

WHAT YOU'LL DO

- Lead study design through collaboration with internal management, regulatory advisors, reimbursement specialists, and KOL advisory committees to ensure trials lead to successful clearance, payor coverage, and revenue ramp.

- Own clinical study execution from protocol development through final study report — including feasibility, site selection, activation, enrollment management, monitoring, and close-out.

- Write and manage IRB/Ethics submissions, informed consent forms (ICFs), and all study-related essential documents.

- Select, qualify, and oversee third-party clinical sites and investigators. Serve as the primary point of contact for site teams, ensuring protocol compliance, enrollment targets, and data quality.

- Manage clinical data operations, including CRF/eCRF design, data review, query resolution, and coordination with data management vendors or internal teams.

- Communicate directly with study sites and subjects as needed — you're comfortable picking up the phone and solving problems in real time.

- Develop and maintain study timelines, budgets, and risk mitigation plans. Flag issues early, propose solutions, and keep leadership informed with clear, concise reporting.

- Ensure compliance with FDA regulations (21 CFR Parts 11, 50, 56, 812, 820), ICH-GCP, ISO 14155, and applicable SaMD guidance documents.

- Manage relationships with CROs and other clinical vendors, including contract negotiation, performance oversight, and issue resolution.

- Collaborate cross-functionally with regulatory affairs, product, engineering, data science, and legal teams to ensure clinical strategies align with product development and submission timelines.

- Participate in regulatory interactions with the FDA and other notified bodies/ agencies by supporting your RA/QA peers in the creation of pre-subs, 510(k) submissions, and other correspondence.

- Build and scale the clinical operations function — develop SOPs, templates, tracking systems, and processes that can grow with the company.

WHAT YOU BRING

- 10+ years of hands-on clinical operations experience, with at least 5 years of experience in leadership roles, executing clinical studies for FDA-regulated medical devices, SaMD/digital health products, or combination products. We want someone who has designed, run, and successfully translated trials into regulatory approvals and marketed products.

- 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).

- Experience with clinical study budgeting, vendor management, and CRO oversight.

- Familiarity with the documentation and adjudication of AEs, device deficiencies, and associated reporting require

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