Role overview

WHOOP is seeking a Director of Clinical Research Operations to lead the clinical operations function supporting the company’s regulated and unregulated health features, with emphasis on Software as a Medical Device (SaMD). In this role, you will own operational strategy and study execution across the entire product lifecycle, from early feasibility through validation, regulatory submission, launch, and post-market evidence generation.

Key responsibilities

Develop and execute operational strategy across WHOOP’s portfolio of regulated and unregulated health features, managing studies from feasibility assessment through post-market evidence generation.
Create fit-for-purpose operational models for both internally executed studies and CRO-managed validation studies, balancing speed, quality, cost, and regulatory requirements.
Lead study startup, planning, execution, monitoring, and closeout activities while ensuring timelines, budgets, enrollment targets, and regulatory requirements are achieved.
Oversee participant recruitment, enrollment, retention, study logistics, and data collection activities across internally executed and externally managed studies.
Manage operational oversight of CROs, technology vendors, recruitment partners, and other external service providers through scalable governance frameworks and performance metrics.
Build and oversee capabilities for internally executed studies, including decentralized clinical trials, feasibility studies, algorithm development studies, and product research initiatives.
Ensure studies comply with GCP, FDA regulations, ISO 14155, and company procedures while supporting audits, inspections, and regulatory submissions.
Build and lead a high-performing Clinical Operations team through hiring, mentoring, and establishing scalable processes and standards.

Requirements

Bachelor’s degree required; advanced degree such as MS, MPH, MBA, RN, PharmD, or PhD preferred.
At least 10 years of experience in clinical operations, clinical research, medical devices, digital health, diagnostics, pharmaceuticals, or another regulated healthcare environment.
At least 5 years of experience leading multidisciplinary clinical operations teams encompassing Clinical Trial Management, Clinical Monitoring, Clinical Data Management, Study Startup, and Clinical Operations functions.
Demonstrated experience overseeing CRO-managed clinical studies and external vendor partnerships.
Deep expertise in clinical trial execution, study startup, participant recruitment, monitoring, enrollment, clinical data management, trial master file oversight, and study closeout.
Strong understanding of GCP, FDA regulations, ISO 14155, IRB and Ethics Committee processes, and medical device clinical research requirements.
Excellent written and verbal communication skills with the ability to translate complex operational, clinical, and regulatory concepts for diverse audiences.

What makes this role worth considering

This position offers the opportunity to shape clinical operations strategy at a digital health company focused on performance optimization. You will work across the complete spectrum of clinical research, from early-stage feasibility through post-market evidence, managing both internally executed and externally managed studies while building and leading a high-performing team.