Director of Clinical Affairs

Eight Sleep

Director of Clinical Affairs leading FDA-regulated clinical studies for Eight Sleep’s sleep technology. Owning study execution, regulatory submissions, clinical data, sites, CROs, and operational scale-up.

Posted 8/17/2026full-timeBoston • California, Massachusetts • 🇺🇸 United StatesLead💰 $200,000 - $250,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in clinical operations, including study design, execution, and compliance with FDA regulations. Proficient in managing cross-functional teams and vendor relationships while ensuring data quality and protocol adherence.

Highest-signal resume keywords

Clinical Study DesignFDA Regulations ComplianceCross-Functional Program ManagementIRB/Ethics SubmissionsClinical Data Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical OperationsProtocol DevelopmentSite SelectionData ReviewECRF DesignBudget ManagementVendor ManagementKOL Relationship CultivationRisk Mitigation PlanningAdverse Event Documentation

Soft Skills

Excellent Communication SkillsLeadership Experience

Tools & Technologies

Clinical Trial Management SystemsSOPsTracking Systems

Certifications & Qualifications

Bachelor's DegreeACRP CertificationSOCRA Certification

Industry Keywords

FDA-Regulated Medical DevicesSaMDDigital Health ProductsICH-GCPISO 14155CRO OversightDecentralized Clinical TrialsRWE Study Designs510(k) SubmissionsBreakthrough Device Designations

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead clinical study design with internal management, regulatory advisors, reimbursement specialists, and KOL advisory committees
Own clinical study execution from protocol development through final study 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 for site teams and ensure protocol compliance, enrollment targets, and data quality
Manage clinical data operations, including CRF/eCRF design, data review, query resolution, and vendor coordination
Communicate directly with study sites and subjects as needed
Develop and maintain study timelines, budgets, and risk mitigation plans
Ensure compliance with FDA regulations, ICH-GCP, ISO 14155, and applicable SaMD guidance
Manage CRO and clinical vendor relationships, including contract negotiation, performance oversight, and issue resolution
Collaborate with regulatory affairs, product, engineering, data science, and legal teams
Support FDA and notified-body interactions, pre-subs, 510(k) submissions, and related correspondence
Build and scale the clinical operations function through SOPs, templates, tracking systems, and scalable processes

Requirements

What you’ll need

10+ years of hands-on clinical operations experience executing clinical studies for FDA-regulated medical devices, SaMD/digital health products, or combination products
At least 5 years of experience in leadership roles
Track record of leadership or critical participation in trials leading to FDA clearances/approvals or meaningful labeling expansions
Experience managing third-party clinical sites, including site selection, activation, monitoring, and close-out
Ability to author IRB/Ethics submissions, informed consent forms, and clinical protocols
7+ years of cross-functional program management involving clinical, engineering, and regulatory teams
Strong working knowledge of clinical data management, including eCRF design, data cleaning, query management, and database lock processes
Fluency in FDA device regulations, including IDE, De Novo, and 510(k) clinical requirements
Knowledge of ICH-GCP and ISO 14155
Familiarity with SaMD-specific guidance and FDA Digital Health frameworks
Experience with clinical study budgeting, vendor management, and CRO oversight
Familiarity with documentation and adjudication of adverse events, device deficiencies, and reporting requirements
Experience cultivating KOL relationships
Excellent written and verbal communication skills
Bachelor's degree required
ACRP or SOCRA certification is a plus, not required
Bonus: experience with biosensing devices, consumer health technology, wellness platforms, RWE study designs, decentralized/hybrid clinical trials, FDA breakthrough device designations, pre-submission meetings, or high-growth startups
Ability to work onsite in Boston or San Francisco 3 days per week
Visa sponsorship may be relevant; applicants are asked whether they require US visa sponsorship

Benefits

Comp & perks

Equity participation for every full-time team member
Periodic equity refreshes based on performance
Every employee receives their own Pod
Health, vision, and dental insurance for employees and dependents
Other perks
Immediate responsibility and accelerated career growth
Professional opportunity to work on innovative sleep fitness technology