Responsibilities

We'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.
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.

Director of Clinical Affairs at Eightsleep · LumiJobs

Director of Clinical Affairs

Responsibilities

Qualification

Preferred

Benefits

Company

Eightsleep

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