Director, Clinical Operations

Requirements

• Own the clinical operations strategy across WHOOP's portfolio of regulated and unregulated health features, including feasibility, validation, regulatory submission, launch, and post-market evidence generation.
• Develop and execute fit-for-purpose operational models for both internally executed studies and CRO-managed validation studies, ensuring efficient evidence generation across the product lifecycle.
• Partner with Clinical Science and cross-functional leadership to develop study execution strategies, resource plans, vendor models, and operational timelines that balance speed, quality, cost, and regulatory requirements.
• Lead study startup, planning, execution, monitoring, and closeout activities, ensuring timelines, budgets, enrollment targets, quality objectives, and regulatory requirements are achieved.
• Oversee participant recruitment, enrollment, retention, study logistics, and data collection activities across both internally executed and externally managed studies.
• Lead operational oversight of CROs, technology vendors, recruitment partners, and other external service providers, establishing scalable governance frameworks, performance metrics, and escalation pathways to ensure high-quality delivery and accountability.
• Build and oversee capabilities for internally executed studies, including decentralized clinical trials (DCTs), feasibility studies, algorithm development studies, and product research initiatives.
• Oversee Clinical Data Management and clinical trial technologies, ensuring high-quality, timely, and compliant data collection, management, and delivery across systems including EDC, CTMS, eConsent, ePRO, eTMF, and remote study platforms.
• Oversee study startup and regulatory operations activities, including feasibility assessments, investigator and site selection, IRB and Ethics Committee submissions, global ethics approvals, essential document management, study activation, and Trial Master File inspection readiness.

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Company Intel

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