Director, Clinical Operations
Generate Biomedicines · Remote
Clinical OperationsRemoteCompany career page
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Role summary
Generate Biomedicines seeks a Director of Clinical Operations to lead global Phase 3 studies with full accountability for strategy, execution, quality, and budget. The role includes direct management of clinical operations staff and cross-functional collaboration across development functions.
What they're looking for
- 12–15+ years clinical operations experience in pharmaceutical or biotechnology
- Bachelor's degree required; advanced degree (MS, MPH, PharmD, PhD) strongly preferred
- Significant experience leading global late-phase Phase 3 studies
- Demonstrated success in direct people management and team development
- Proven ability to lead complex cross-functional teams
- Knowledge of ICH-GCP and global regulatory compliance requirements
What you'll be doing
- Provide strategic oversight and end-to-end operational leadership for global Phase 3 studies
- Directly manage and develop Clinical Operations staff including Clinical Study Leads and Clinical Trial Managers
- Lead multidisciplinary study teams and serve as primary point of accountability across internal and external stakeholders
- Oversee study startup, site strategy, enrollment execution, and ensure compliance with regulatory requirements
- Drive operational excellence through performance metrics, risk management, and continuous improvement initiatives
Privacy & handoff
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