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Eight Sleep is a sleep fitness company building hardware, software, and AI technology to optimize human recovery and performance. The company is recognized as one of Fast Company's Most Innovative Companies and has been named to TIME's Best Inventions multiple times.
As Director of Clinical Affairs, you will own end-to-end execution of regulatory-driven clinical studies for medical devices and digital health products. This is a hands-on, operationally intense role requiring someone who can stand up studies from scratch, manage third-party clinical sites, write IRB and informed consent documents, oversee data management, establish study committees, prepare for FDA submissions and audits, and drive studies to completion on time and budget.
Key responsibilities include:
- Lead study design in collaboration with internal teams, regulatory advisors, and KOL committees to ensure successful FDA clearance, payor coverage, and revenue growth
- Own clinical study execution from protocol development through final report, including feasibility, site selection, activation, enrollment, monitoring, and close-out
- Write and manage IRB/Ethics submissions, informed consent forms, and essential study documents
- Select, qualify, and oversee third-party clinical sites and investigators; serve as primary point of contact
- Manage clinical data operations including eCRF design, data review, query resolution, and vendor coordination
- Communicate directly with study sites and subjects to solve problems in real time
- Develop and maintain study timelines, budgets, and risk mitigation plans
- Ensure compliance with FDA regulations (21 CFR Parts 11, 50, 56, 812, 820), ICH-GCP, ISO 14155, and SaMD guidance
- Manage CRO and clinical vendor relationships, including contract negotiation and performance oversight
- Collaborate cross-functionally with regulatory affairs, product, engineering, data science, and legal teams
- Participate in FDA regulatory interactions and pre-submission meetings
- Build and scale clinical operations function with SOPs, templates, and processes
Required qualifications:
- 10+ years hands-on clinical operations experience with at least 5 years in leadership roles executing clinical studies for FDA-regulated medical devices, SaMD/digital health, or combination products
- Track record of leadership or critical participation in trials leading to FDA clearances/approvals or meaningful labeling expansions
- Demonstrated experience managing third-party clinical sites (selection, activation, monitoring, close-out)
- Proven ability to author IRB/Ethics submissions, informed consent forms, and clinical protocols
- 7+ years cross-functional program management involving clinical, engineering, and regulatory teams
- Strong working knowledge of clinical data management (eCRF design, data cleaning, query management, database lock)
- Fluency in FDA device regulations (IDE, De Novo, 510(k) clinical requirements), ICH-GCP, ISO 14155, and SaMD guidance
- Experience with clinical study budgeting, vendor management, and CRO oversight
- Familiarity with adverse event documentation, device deficiency adjudication, and reporting requirements
