Whoop
Director, Clinical Operations
Boston, MA · Director · Full-time
Sponsorship not specified$210k-$230kDetected 11 days ago
GCPProduct ManagementForecastingLogisticsClinical TrialsClinical ResearchFDA RegulatoryMedical DevicesResearchLeadershipCommunicationMentoring
About the role
- 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 strengthen WHOOP's clinical operations capabilities and ensure our study execution strategy meets the expectations of regulators, investigators, participants, and the business.
Responsibilities
- As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply.
- 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.
- You will build and mentor a high-performing Clinical Operations organization.
Requirements
- 5+ years of experience leading multidisciplinary clinical operations teams, including Clinical Trial Management, Clinical Monitoring, Clinical Data Management, Study Startup, and Clinical Operations functions.
- The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office.
- 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.
Nice to have
- advanced degree (MS, MPH, MBA, RN, PharmD, PhD, or equivalent) preferred.
- Bachelor's degree required
Compensation
- At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success.
- The U.S. base salary range for this full-time position is $210,000-$230,000 Salary ranges are determined by role, level, and location.
- In addition to the base salary, the successful candidate will also receive benefits and a generous equity package.
Benefits
- 10+ years of experience in clinical operations, clinical research, medical devices, digital health, diagnostics, pharmaceuticals, or another regulated healthcare environment.
- Strong understanding of GCP, FDA regulations, ISO 14155, IRB/Ethics Committee processes, and medical device clinical research requirements.
- Within each range, individual pay is based on factors such as job-related skills, experience, performance, and relevant education or training.
Company info
- At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience.
Equal opportunity
- WHOOP is an Equal Opportunity Employer and participates in E-verify https://www.e-verify.gov/ to determine employment eligibility.
This listing is sourced directly from Whoop's careers page and normalized into a canonical job model.