Director, Clinical Operations

Whoop•Boston, MA

1d•Onsite

About The Position

As the Director, Clinical Operations, you will lead the clinical operations function responsible for executing the studies that support WHOOP’s regulated and unregulated health features, with a particular focus on Software as a Medical Device (SaMD). You will own operational strategy and study execution across the product lifecycle, from early concept and feasibility through validation, regulatory submission, launch, and post-market evidence generation. This role requires deep expertise in clinical trial operations, decentralized clinical trials, vendor oversight, and operational execution within regulated healthcare environments. As both a strategic leader and hands-on expert, you will oversee studies conducted through CROs as well as internally executed studies, ensuring high-quality, efficient, and compliant execution across WHOOP’s clinical portfolio. You will build and mentor a high-performing Clinical Operations organization. You will strengthen WHOOP’s clinical operations capabilities and ensure our study execution strategy meets the expectations of regulators, investigators, participants, and the business.

Requirements

Bachelor’s degree required; advanced degree (MS, MPH, MBA, RN, PharmD, PhD, or equivalent) preferred.
10+ years of experience in clinical operations, clinical research, medical devices, digital health, diagnostics, pharmaceuticals, or another regulated healthcare environment.
5+ years of experience leading multidisciplinary clinical operations teams, including 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.
Experience leading internally executed clinical research programs, including decentralized clinical trials, participant-facing operations, site management, direct-to-participant research, or hybrid study models.
Deep expertise in clinical trial execution, study startup, participant recruitment, monitoring, enrollment, clinical data management, trial master file oversight, and study closeout activities.
Experience managing clinical study budgets, vendor contracts, resource forecasting, and portfolio planning.
Strong understanding of GCP, FDA regulations, ISO 14155, IRB/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.

Responsibilities

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.
Ensure studies are conducted in accordance with GCP, FDA regulations, ISO 14155, company procedures, and quality requirements, while supporting audits, inspections, and regulatory submissions.
Build and lead a high-performing Clinical Operations organization, including hiring, mentoring, workforce planning, and establishing scalable processes, standards, and operating models.
Communicate study progress, operational risks, resource needs, vendor performance, and portfolio status to executive leadership and key stakeholders.