The RoleWe're looking for a
Director of Clinical Affairs who will own the end-to-end execution of our regulatory-driven clinical studies. This is a hands-on, operationally intense position for someone who knows how to stand up a study from scratch, manage third-party clinical sites, write IRB and informed consent documents, oversee data management, establish and oversee any study committees (EC, DSMB, etc.), prepare for FDA submissions and audits, and drive studies to completion on time and on budget.
You'll be the connective tissue between our internal teams and the external clinical sites, investigators, IRBs, CROs, regulatory agencies, and, when necessary, study subjects directly. You'll bring deep fluency in regulatory requirements for medical devices, and you'll have a track record of delivering clinical studies that have supported regulatory submissions.
What You'll Do- 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.
- 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 (ICFs), and all study-related essential documents.
- Select, qualify, and oversee third-party clinical sites and investigators. Serve as the primary point of contact for site teams, ensuring protocol compliance, enrollment targets, and data quality.
- Manage clinical data operations, including CRF/eCRF design, data review, query resolution, and coordination with data management vendors or internal teams.
- Communicate directly with study sites and subjects as needed - you're comfortable picking up the phone and solving problems in real time.
- Develop and maintain study timelines, budgets, and risk mitigation plans. Flag issues early, propose solutions, and keep leadership informed with clear, concise reporting.
- Ensure compliance with FDA regulations (21 CFR Parts 11, 50, 56, 812, 820), ICH-GCP, ISO 14155, and applicable SaMD guidance documents.
- Manage relationships with CROs and other clinical vendors, including contract negotiation, performance oversight, and issue resolution.
- Collaborate cross-functionally with regulatory affairs, product, engineering, data science, and legal teams to ensure clinical strategies align with product development and submission timelines.
- 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.
- Build and scale the clinical operations function - develop SOPs, templates, tracking systems, and processes that can grow with the company.
What You Bring- 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. We want someone who has designed, run, and successfully translated trials into regulatory approvals and marketed 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.
Bonus Points- 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 where you had to build processes from the ground up.
- Experience supporting FDA breakthrough device designations or pre-submission meetings.
CompensationTarget Base Salary: $200,000 - $250,000*
*Compensation is based on experience, qualifications, and market benchmarks for the respective location you will be based in (i.e. SF or Boston). Equity and performance-based incentives are a significant component of total compensation at Eight Sleep.
