Director of Clinical Operations

4w1 month ago

WHOOP

Boston, US · Full-time · $210,000 – $230,000

About this role

As the Director of Clinical Operations, you will lead the clinical operations function responsible for executing 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.

You will develop fit-for-purpose operational models for both internally executed studies and CRO-managed validation studies, ensuring efficient evidence generation. Your day-to-day involves overseeing study startup, planning, execution, monitoring, and closeout, while managing participant recruitment, vendor oversight, and data collection activities.

You will build and mentor a high-performing Clinical Operations organization, strengthening capabilities and ensuring study execution meets the expectations of regulators, investigators, participants, and the business. This role requires deep expertise in clinical trial operations, decentralized clinical trials, and operational execution within regulated healthcare environments.

This position offers the opportunity to shape WHOOP's clinical operations strategy and lead a portfolio that spans from early concept through regulatory submission and post-market evidence generation. You will partner with Clinical Science and cross-functional leadership to drive efficient, high-quality, and compliant study execution.

Requirements

10+ years of experience in clinical operations within regulated healthcare environments.
Deep expertise in clinical trial operations, decentralized clinical trials, vendor oversight, and operational execution.
Experience leading both internally executed studies and studies conducted through CROs.
Proven ability to oversee study startup, regulatory operations, and management of clinical trial technologies including EDC, CTMS, eConsent, ePRO, eTMF, and remote study platforms.
Strong knowledge of GCP, FDA regulations, and ISO 14155.
Experience supporting audits, inspections, and regulatory submissions.
Demonstrated ability to build and mentor a clinical operations organization.
Experience managing participant recruitment, enrollment, retention, and study logistics for regulated health studies.

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.
Lead operational oversight of CROs, technology vendors, recruitment partners, and other external service providers, establishing scalable governance frameworks, performance metrics, and escalation pathways.
Build and oversee capabilities for internally executed studies, including decentralized clinical trials (DCTs), feasibility studies, algorithm development studies, and product research initiatives.
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.

Benefits

Lead a high-impact clinical operations function at a leading health technology company.
Opportunity to shape operational strategy for cutting-edge Software as a Medical Device (SaMD) products.
Work on a portfolio spanning regulated and unregulated health features.
Build and mentor a high-performing Clinical Operations team.