Company
Health & Medical
Director,ClinicalOperations
Neural analysis suggests this role is
optimal for Director candidates.
“Director, Clinical Operations. Skills: Clinical operations, Clinical trial execution, Vendor management, Regulatory compliance. Own clinical operations strategy. Develop operational models”
What You'll Achieve.
Achieve timelines; Achieve budgets; Achieve enrollment targets; Achieve quality objectives; Achieve regulatory requirements; Ensure high-quality delivery; Ensure accountability
Industry & Context.
What They're Looking For.
Must Have
10+ years clinical operations experience, 5+ years leading teams, Oversight of CRO-managed studies, Experience leading internally executed programs, Expertise in clinical trial execution, Experience managing study budgets, Understanding of GCP, Understanding of FDA regulations, Understanding of ISO 14155, Understanding of IRB/Ethics Committee processes, Understanding of medical device research requirements
Nice to Have
Advanced degree preferred
What You'll Do.
Own clinical operations strategy
Develop operational models
Execute operational models
Partner with Clinical Science
Partner with cross-functional leadership
Develop study execution strategies
Develop resource plans
Develop vendor models
Develop operational timelines
Lead study startup activities
Lead study planning activities
Lead study execution activities
Lead study monitoring activities
Lead study closeout activities
Oversee participant recruitment
Oversee participant enrollment
Oversee participant retention
Oversee study logistics
Oversee data collection activities
Lead operational oversight of CROs
Lead operational oversight of vendors
Establish governance frameworks
Establish performance metrics
Establish escalation pathways
Build internal capabilities
Oversee internal capabilities
Oversee Clinical Data Management
Oversee clinical trial technologies
Oversee study startup activities
Oversee regulatory operations activities
Ensure GCP compliance
Ensure FDA regulation compliance
Ensure ISO 14155 compliance
Ensure company procedure compliance
Ensure quality requirements compliance
Support regulatory submissions
Build Clinical Operations organization
Lead Clinical Operations organization
Communicate study progress
Communicate operational risks
Communicate resource needs
Communicate vendor performance
Communicate portfolio status
How You'll Work.
Team & Collaboration
Cross-functional leadership; Clinical Science teams
Communication Scope
Written communication; Verbal communication; Translate complex concepts
Process & Methodology
Portfolio planning, Resource planning, Timeline management
Full Job Description
## QUALIFICATIONS 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 a
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