Director of Clinical Affairs

Eight Sleep
Boston, San Francisco
Workplace: HybridFull timeUSD 200,000 - 250,000 annuallyFunction: Executive & General ManagementExperience: 10+ yearsEducation: bachelorsSkills: ["Communication","Leadership","Risk management","Cross-functional collaboration"]

Own end-to-end execution of regulatory-driven clinical studies for medical devices and SaMD, building trials from scratch through completion. Lead study design, feasibility, site selection, activation, enrollment management, monitoring, close-out, and final reporting. Author and manage IRB/Ethics and informed consent documents, oversee clinical data operations, and ensure compliance with FDA, ICH-GCP, and ISO 14155. Partner with CROs and internal teams, and build scalable clinical operations processes.

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FursaFursa
Eight Sleep
Eight Sleep
2 days ago

Director of Clinical Affairs

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Job Summary

Own end-to-end execution of regulatory-driven clinical studies for medical devices and SaMD, building trials from scratch through completion. Lead study design, feasibility, site selection, activation, enrollment management, monitoring, close-out, and final reporting. Author and manage IRB/Ethics and informed consent documents, oversee clinical data operations, and ensure compliance with FDA, ICH-GCP, and ISO 14155. Partner with CROs and internal teams, and build scalable clinical operations processes.
Location: Boston, San Francisco
Workplace: Hybrid
Employment Type: Full time
Job Function: Executive & General Management
Seniority: Director level

Key Responsibilities

  • •Lead study design and collaboration with internal management, regulatory advisors, reimbursement specialists, and KOL committees to support 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, and all essential study documents, ensuring compliance with FDA regulations (21 CFR), ICH-GCP, ISO 14155, and applicable SaMD guidance.
  • •Select, qualify, and oversee third-party clinical sites and investigators; serve as primary site contact to ensure protocol compliance, enrollment targets, and data quality.
  • •Manage clinical data operations (CRF/eCRF design, data review, query resolution) and coordinate with vendors or internal teams while building study timelines, budgets, risk mitigation, and CRO relationships.

Pay and Benefits

Salary: USD 200,000 - 250,000 annually
Equity and Bonus:Equity
Perks:Health InsuranceVisionDental

Key Requirements

  • •10+ years of hands-on clinical operations experience, including 5+ years leading clinical studies for FDA-regulated medical devices, SaMD/digital health, or combination products.
  • •Track record delivering trials that supported FDA clearances/approvals or meaningful labeling expansions.
  • •Experience managing third-party clinical sites and investigators across site selection, activation, monitoring, and close-out.
  • •Proven ability to author IRB/Ethics submissions, informed consent forms (ICFs), and clinical protocols.
  • •Strong clinical data management experience (eCRF design, query resolution, data cleaning, and database lock processes) plus fluency in FDA device regulations and ICH-GCP/ISO 14155.
Experience:10+ yearsFDA-regulated medical devicesSaMDDigital healthCombination products
Education:Bachelor's
Skills:CommunicationLeadershipRisk managementCross-functional collaboration
Certifications:ACRPSOCRA
Tech Stack:IRBEthics submissionsInformed consent forms (ICFs)ICFCRFECRFICH-GCPISO 14155FDA regulations21 CFR Parts 1121 CFR Part 5021 CFR Part 5621 CFR Part 81221 CFR Part 820SaMD guidanceIDEDe Novo510(k)DSM BEC

Company Brief

Eight Sleep
Eight Sleep makes AI-powered sleep hardware and software (the Pod) that monitors biometrics and adjusts temperature, elevation, and sound to improve sleep and recovery for consumers and clinical applications. Recent expansion targets medical use cases and global retail. ([crunchbase.com](https://www.crunchbase.com/organization/eight-sleep?utm_source=openai))
Industry: Wellness & Preventive Health
Company Size: Medium (51 to 250 employees)
Growth: Scaleup
Valuation: USD 250M to 500M
Funding: Series D
Headquarters: New York, United States
Founded: 2014
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