Senior Director, Clinical Operations

Keros Therapeutics seeks a Senior Director of Clinical Operations to lead cross-functional clinical program teams and oversee the planning and execution of assigned clinical trials. This hybrid role in Lexington, MA involves managing internal teams and external vendors while ensuring trials meet timelines, budgets, and regulatory standards.

Responsibilities

• Lead cross-functional program teams to deliver clinical trial objectives within timelines, budgets, and quality standards
• Evaluate and select clinical vendors; develop scope of work and manage vendor relationships
• Oversee clinical operations resources and serve as escalation point for vendor and team issues
• Develop trial protocols, feasibility strategies, and study-related materials with operational input
• Manage study budgets, forecasting, contract negotiations, and implement corrective actions for data quality

Requirements

• Minimum 12 years clinical operations experience in biotech, pharmaceutical, or CRO sectors
• Demonstrated Phase 1/2/3 global clinical study experience
• 5+ years of people management and team leadership experience
• Experience managing rare and/or complex disease trials
• Strong understanding of FDA regulations and GCP compliance