Director, Clinical Research Operations

Whoop•Boston, MA

1d•$210,000 - $230,000•Onsite

About The Position

At WHOOP, the Director, Clinical Research Operations leads the clinical operations function responsible for executing studies that support regulated and unregulated health features, with a particular focus on Software as a Medical Device (SaMD). The role owns operational strategy and study execution across the product lifecycle, from early concept and feasibility through validation, regulatory submission, launch, and post-market evidence generation. The Director oversees studies conducted through CROs as well as internally executed studies, ensuring high-quality, efficient, and compliant execution across WHOOP’s clinical portfolio. The position requires expertise in clinical trial operations, decentralized clinical trials, vendor oversight, and operational execution in regulated healthcare environments, combining strategic leadership with hands-on operational expertise. The role builds and mentors a high-performing Clinical Operations organization, strengthens WHOOP’s clinical operations capabilities, and ensures study execution meets the expectations of regulators, investigators, participants, and the business. It is based in WHOOP’s Boston, Massachusetts office; the successful candidate must be prepared to relocate if necessary. The full-time position has a U.S. base salary range of $210,000–$230,000, plus benefits and an equity package.

Requirements

Bachelor’s degree required.
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.
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, including the ability to explain complex operational, clinical, and regulatory concepts to diverse audiences.
Must be prepared to relocate if necessary to work from WHOOP’s Boston, Massachusetts office.

Nice To Haves

Advanced degree such as an MS, MPH, MBA, RN, PharmD, PhD, or equivalent.

Responsibilities

Own clinical operations strategy across 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 internally executed studies and CRO-managed validation studies.
Partner with Clinical Science and cross-functional leaders on study execution strategies, resource plans, vendor models, and operational timelines.
Lead study startup, planning, execution, monitoring, and closeout, meeting timeline, budget, enrollment, quality, and regulatory objectives.
Oversee participant recruitment, enrollment, retention, study logistics, and data collection for internal and externally managed studies.
Oversee CROs, technology vendors, recruitment partners, and other service providers; establish governance frameworks, performance metrics, and escalation pathways.
Build and oversee capabilities for internally executed studies, including decentralized clinical trials, feasibility studies, algorithm development studies, and product research initiatives.
Oversee Clinical Data Management and clinical trial technologies, including EDC, CTMS, eConsent, ePRO, eTMF, and remote study platforms.
Oversee study startup and regulatory operations, 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 comply with GCP, FDA regulations, ISO 14155, company procedures, and quality requirements; support audits, inspections, and regulatory submissions.
Build and lead the 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.