Director, Clinical Operations

Role Summary

Director, Clinical Operations at Keros Therapeutics. Lead cross-functional Clinical Study Sub Team to execute clinical trials aligned with program and corporate objectives, with responsibility for trial design, timelines, budgets, and deliverables, and for driving operational excellence across studies.

Responsibilities

• Leads and manages the cross-functional Clinical Study Sub Team to ensure deliverables are met within established timelines, budget, and quality and compliance standards.
• Represents clinical operations at external and internal meetings.
• Determines the clinical vendor strategy for assigned studies, participates in vendor evaluation and selection, and develops scope of work.
• Oversees and manages Clinical Trial Leads/Managers, Clinical Trial Associates, and other assigned roles.
• Serves as the escalation point for clinical operations.
• Contributes to development of clinical trial processes and procedures to enhance efficiency and effectiveness from protocol design through completion.
• Ensures clinical trial protocols go through all internal review and approval processes.
• Guides trial leads/managers in developing trial-related materials (e.g., training and recruitment materials).
• Contributes to operational study plans (start-up, project and site management, communication).
• Contributes to feasibility exercises and site/country selection.
• Guides team in risk management, identification, mitigation planning, and proactive communication.
• Ensures Good Clinical Practice and inspection readiness with complete documentation and trial master file maintenance.
• Serves as primary contact for Quality Assurance, developing integrated audit plans across vendors to achieve high data quality.
• Contributes to study budget management including forecasting and accrual reviews, and clinical contract management.
• Contributes to innovative solutions to overcome challenges within clinical operations and other functions.

Qualifications

• Required: At least 10 years of clinical operations experience with a biotech/pharmaceutical company.
• Required: Phase 2/3 international clinical study leadership experience.
• Required: 5 years or more of people management.
• Required: Experience in neuromuscular or related diseases.
• Required: Vendor oversight and management.
• Required: Understanding of FDA, EMEA, GDPR, ICH and GCP regulations and guidelines.
• Preferred: Experience in pediatric and/or rare diseases.

Education

• BA/BS in a clinical or scientific discipline.

Additional Requirements

• Potential base pay range: $205,000‚Äî$239,000 USD.