Director, Clinical Operations

Whoop
Boston
Workplace: OnsiteFull timeUSD 210,000 - 230,000 annuallyFunction: Laboratory & Clinical OperationsExperience: 10+ yearsEducation: bachelorsSkills: ["Communication","Leadership","Mentoring"]

Lead WHOOP’s Clinical Operations organization overseeing study execution for regulated and unregulated health features, with a focus on Software as a Medical Device (SaMD). Own operational strategy across the full study lifecycle—from feasibility through validation, regulatory submissions, launch, and post-market evidence. Manage CRO and internal studies, participant recruitment and operations, and clinical data management systems (EDC, CTMS, eConsent, ePRO, eTMF) while ensuring GCP/FDA/ISO 14155 compliance.

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FursaFursa
Whoop
Whoop
4 weeks ago

Director, Clinical Operations

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Last checked: 8 hours agoStatus: Live

Job Summary

Lead WHOOP’s Clinical Operations organization overseeing study execution for regulated and unregulated health features, with a focus on Software as a Medical Device (SaMD). Own operational strategy across the full study lifecycle—from feasibility through validation, regulatory submissions, launch, and post-market evidence. Manage CRO and internal studies, participant recruitment and operations, and clinical data management systems (EDC, CTMS, eConsent, ePRO, eTMF) while ensuring GCP/FDA/ISO 14155 compliance.
Location: Boston
Workplace: Onsite
Employment Type: Full time
Job Function: Laboratory & Clinical Operations
Seniority: Director level

Key Responsibilities

  • •Own clinical operations strategy across WHOOP’s portfolio, including feasibility, validation, regulatory submission, launch, and post-market evidence generation.
  • •Develop and execute operational models for internally executed studies and CRO-managed validation studies across the product lifecycle.
  • •Lead end-to-end study startup, planning, execution, monitoring, and closeout to meet timelines, budgets, enrollment targets, and regulatory requirements.
  • •Oversee participant recruitment, enrollment, retention, study logistics, and data collection for both internal and CRO-managed studies.
  • •Provide operational oversight of CROs and external service providers; establish governance frameworks, performance metrics, and escalation pathways while ensuring compliance with GCP/FDA/ISO 14155.

Pay and Benefits

Salary: USD 210,000 - 230,000 annually
Equity and Bonus:Equity
Perks:Equity

Key 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 leading multidisciplinary clinical operations teams across areas such as Clinical Trial Management, Clinical Monitoring, Clinical Data Management, and Study Startup.
  • •Demonstrated experience overseeing CRO-managed studies and external vendor partnerships.
  • •Strong understanding of GCP, FDA regulations, ISO 14155, and IRB/Ethics Committee processes for medical device clinical research.
Experience:10+ yearsClinical researchMedical devicesDigital healthPharmaceuticalsRegulated healthcare
Education:Bachelor's
Skills:CommunicationLeadershipMentoring
Tech Stack:EDCCTMSEConsentEPROETMFRemote study platforms

Company Brief

Whoop
Whoop designs and sells a subscription-based wearable fitness tracker and analytics platform that monitors recovery, strain, and sleep to optimize athletic performance and daily health for consumers and professional athletes.
Industry: Wearables
Company Size: Large (251 to 1,000 employees)
Growth: Scaleup
Valuation: Unicorn (USD 1B+)
Funding: Series E+
Headquarters: Boston, United States
Founded: 2012
WebsiteLinkedIn