Director, Clinical Research Operations

The role

You will lead the clinical operations function responsible for executing studies that support regulated and unregulated health features. You will own operational strategy and study execution across the product lifecycle, including Software as a Medical Device.

What you will do

• Own the clinical operations strategy across the portfolio of regulated and unregulated health features.
• Develop and execute operational models for internally executed and CRO-managed studies.
• Partner with Clinical Science and cross-functional leadership on study execution strategies and resource plans.
• Lead study startup, planning, execution, monitoring, and closeout activities.
• Oversee participant recruitment, enrollment, retention, study logistics, and data collection.
• Lead operational oversight of CROs, technology vendors, and recruitment partners.
• Build and oversee capabilities for internally executed studies including decentralized clinical trials.
• Oversee Clinical Data Management and clinical trial technologies.
• Oversee study startup and regulatory operations activities.
• Build and lead a high-performing Clinical Operations organization.

Required qualifications

• 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
• Demonstrated experience overseeing CRO-managed clinical studies and external vendor partnerships
• Experience leading internally executed clinical research programs
• Deep expertise in clinical trial execution, study startup, participant recruitment, monitoring, enrollment, clinical data management, trial master file oversight, and study closeout activities
• 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

Nice to have

• advanced degree (MS, MPH, MBA, RN, PharmD, PhD, or equivalent)

Benefits

• competitive base salaries
• meaningful equity
• generous equity package

Before you apply

• The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office
• WHOOP participates in E-verify to determine employment eligibility

About the company

WHOOP is on a mission to unlock and inspire performance for life.