Company

Health & Medical

Director,ClinicalOperations

$220–320k ~AI est. Boston, Massachusetts, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Director candidates.

The Brief

“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.

Health & Medical

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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