Director, Clinical Operations

Role Summary

Director, Clinical Operations. Operational leader responsible for the execution strategy of assigned clinical trials to achieve program and corporate objectives. Leads an operational team, represents operational perspectives at cross-functional teams, and drives process improvement, risk management, and timely, compliant trial delivery.

Responsibilities

• Leads and manages the cross-functional Clinical Study Sub Team to ensure deliverables are met within established timelines, budget, quality, and compliance standards.
• Represents clinical operations at external and internal meetings.
• Determines clinical vendor strategy for assigned studies and participates in vendor evaluation and selection with scope of work development.
• 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 ensure efficiency and effectiveness from protocol design to completion.
• Ensures clinical trial protocols go through internal review and approval processes.
• Guides trial-related materials development (e.g., training and recruitment materials).
• Contributes to operational study plans (start-up, project and site management, communication).
• Participates in feasibility exercises and site/country selection.
• Guides team in managing study risks with identification, mitigation planning, and proactive communication.
• Ensures Good Clinical Practice and inspection readiness across studies, with complete documentation and trial master file.
• Acts as primary contact for Quality Assurance, coordinating corrective actions as part of an audit strategy to achieve data quality.
• Contributes to study budget management, including forecasting and contract management.
• Develops 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.

Skills

• Clinical operations leadership
• Vendor management
• Risk management and problem solving
• Budgeting and contract management
• Regulatory compliance (FDA, EMEA, GDPR, ICH/GCP)
• Cross-functional collaboration

Education

• BA/BS in a clinical or scientific discipline