Director of Clinical Affairs

The role

The Director of Clinical Affairs will own the end-to-end execution of regulatory-driven clinical studies. This role involves managing third-party clinical sites, writing regulatory documents, and overseeing data management to support FDA submissions.

What you will do

• Lead study design through collaboration with internal management and advisory committees
• Own clinical study execution from protocol development through final study report
• Write and manage IRB/Ethics submissions, informed consent forms, and study documents
• Select, qualify, and oversee third-party clinical sites and investigators
• Manage clinical data operations including CRF/eCRF design and data review
• Communicate directly with study sites and subjects
• Develop and maintain study timelines, budgets, and risk mitigation plans
• Ensure compliance with FDA regulations, ICH-GCP, and ISO 14155
• Manage relationships with CROs and other clinical vendors
• Collaborate cross-functionally with regulatory, product, engineering, data science, and legal teams

Required qualifications

• 10+ years of hands-on clinical operations experience
• 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 trials leading to FDA clearances/approvals or labeling expansions
• Demonstrated experience managing third-party clinical sites
• Proven ability to author IRB/Ethics submissions, informed consent forms, and clinical protocols
• 7+ years experience of cross-functional program management
• Strong working knowledge of clinical data management
• Fluency in FDA device regulations (IDE, De Novo, 510(k) clinical requirements), ICH-GCP, ISO 14155, and SaMD-specific guidance
• Experience with clinical study budgeting, vendor management, and CRO oversight
• Familiarity with the documentation and adjudication of AEs and device deficiencies
• History of cultivating KOL relationships
• Bachelor's degree

Nice to have

• Advanced degree (MS, MPH, PhD, or clinical doctorate)
• ACRP or SOCRA certification
• Experience with biosensing devices, consumer health technology, or wellness platforms pursuing clinical validation
• Familiarity with real-world evidence (RWE) study designs and decentralized / hybrid clinical trial models
• Prior experience in a high-growth startup or scale-up environment
• Experience supporting FDA breakthrough device designations or pre-submission meetings

Benefits

• Equity participation
• Periodic equity refreshes based on performance
• Your own Pod
• Health insurance
• Vision insurance
• Dental insurance

About the company

Eight Sleep is a sleep fitness company building hardware, software, and AI technology to transform sleep into a personalized, data-driven recovery experience.