Global Phase 3 Clinical Operations Director

Generate:Biomedicines; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Generate:Biomedicines is seeking a Director, Clinical Operations to provide strategic and operational leadership for global Phase 3 development. You will lead one or more late‑stage studies with full accountability for strategy, execution, budget and delivery.

The role includes direct line management of Clinical Operations professionals, hiring and developing high‑performing teams, and shaping operational strategy to strengthen our late‑stage capabilities.

Qualifications

• Extensive 12–15+ years in clinical operations within pharma/biotech.
• Global late-phase (Phase 3) study leadership experience.
• Proven people management: hiring, coaching, performance development.
• Strong CRO oversight, regulatory familiarity, inspection readiness.

Responsibilities

• Provide strategic and operational leadership for global Phase 3 studies.
• Translate strategy into executable plans aligned with regulatory goals.
• Own study timelines, budgets, resource allocation, and quality metrics.
• Lead risk forecasting, mitigation, and scenario planning at program level.
• Oversee cross-functional study teams across Clinical Ops, Data Management, Biostatistics, Safety, Regulatory, and QA.
• Develop and coach Clinical Operations staff and build high-performing teams.

Skills

Leadership

Cross-functional leadership

Strategic planning

CRO oversight

Regulatory knowledge

Education

Bachelor’s degree

Advanced degree preferred

Job description

Generate:Biomedicines is seeking a Director, Clinical Operations to provide strategic and operational leadership for global Phase 3 development. You will lead one or more late‑stage studies with full accountability for strategy, execution, budget and delivery.

The role includes direct line management of Clinical Operations professionals, hiring and developing high‑performing teams, and shaping operational strategy to strengthen our late‑stage capabilities.