Director of Clinical Affairs

Eight Sleep, Inc.

Job Overview

Location

Boston Area

Job Type

Full-time

Full Job Description

📋 Description

• Join the sleep fitness movement at Eight Sleep, a company that's redefining what it means to be well-rested through advanced hardware, software, and AI technology.
• As the Director of Clinical Affairs, you'll own the end-to-end execution of regulatory-driven clinical studies, managing third-party clinical sites, writing IRB and informed consent documents, overseeing data management, and driving studies to completion on time and on budget.
• You'll be the connective tissue between internal teams and external clinical sites, investigators, IRBs, CROs, regulatory agencies, and study subjects.
• You'll bring deep fluency in regulatory requirements for medical devices and a track record of delivering clinical studies that have supported regulatory submissions.
• You'll 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.
• You'll own clinical study execution from protocol development through final study report, including feasibility, site selection, activation, enrollment management, monitoring, and close-out.
• You'll write and manage IRB/Ethics submissions, informed consent forms, and all study-related essential documents.
• You'll select, qualify, and oversee third-party clinical sites and investigators, serving as the primary point of contact for site teams.
• You'll manage clinical data operations, including CRF/eCRF design, data review, query resolution, and coordination with data management vendors or internal teams.
• You'll communicate directly with study sites and subjects as needed, being comfortable picking up the phone and solving problems in real time.
• You'll develop and maintain study timelines, budgets, and risk mitigation plans, flagging issues early and proposing solutions.
• You'll ensure compliance with FDA regulations, ICH-GCP, ISO 14155, and applicable SaMD guidance documents.
• You'll manage relationships with CROs and other clinical vendors, including contract negotiation, performance oversight, and issue resolution.
• You'll collaborate cross-functionally with regulatory affairs, product, engineering, data science, and legal teams to ensure clinical strategies align with product development and submission timelines.
• You'll 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.
• You'll build and scale the clinical operations function, developing SOPs, templates, tracking systems, and processes that can grow with the company.

🎯 Requirements

• 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.
• 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 requirements.
• History of cultivating KOL relationships for participation in protocol development, research partnerships, study sub-committees, manuscripts/presentations/symposia, and related activities.
• Excellent written and verbal communication — you can draft a protocol, run a site initiation visit, and present enrollment updates to executives with equal confidence.
• Bachelor's degree required; advanced degree (MS, MPH, PhD, or clinical doctorate) preferred.
• ACRP or SOCRA certification is a plus.

🏖️ Benefits

• Immediate responsibility and accelerated career growth.
• Work alongside other bright minds like you.
• Equity participation.
• Your own Pod.
• Full access to health, vision, and dental insurance for you and your dependents, plus other perks.

Skills & Technologies

GCP

Hybrid

$200k-250k

Degree Required

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Eight Sleep, Inc.

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About Eight Sleep, Inc.

Eight Sleep designs and sells smart mattresses and sleep accessories that automatically adjust temperature, track biometrics, and integrate with mobile apps. The company targets consumers seeking data-driven sleep optimization through hardware-software combinations including cooling and heating mattress covers and AI-driven coaching insights. Founded in 2014, the company ships products globally and operates on a direct-to-consumer model supported by subscription software services.

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