Senior Clinical Lead – Clinical Operations

Senior Clinical Lead – Clinical Operations Overview

• Lead strategic direction for global Clinical Operations, ensuring alignment with clinical development goals and organizational objectives.
• Develop scalable operational plans to advance clinical programs from early development through registration phases.
• Provide executive oversight of clinical programs, ensuring quality data delivery within approved timelines and budgets.
• Establish governance, standards, and processes to enable consistent and inspection-ready clinical trial execution.
• Build and lead a high-performing Clinical Operations organization, fostering collaboration and continuous improvement.
• Maintain compliance with FDA and global regulatory requirements, ensuring readiness for audits and inspections.
• Collaborate with cross-functional teams to integrate program planning and execution across development phases.
• Provide strategic oversight of clinical trial documentation, ensuring operational feasibility and quality standards.
• Represent Clinical Operations in business development activities, assessing operational feasibility and integration considerations.

Senior Clinical Lead – Clinical Operations Key Responsibilities & Duties

• Set the vision and priorities for global Clinical Operations, aligning with corporate objectives and clinical development portfolio.
• Ensure delivery of quality data within timelines, budgets, and risk parameters through executive oversight of clinical programs.
• Develop integrated global operational strategies, including resource models and critical-path milestones.
• Establish governance frameworks, standards, and performance measures for clinical trial execution.
• Lead workforce planning, capacity management, and financial planning for Clinical Operations.
• Oversee vendor and CRO strategy, including selection, contracting, governance, and performance management.
• Partner with cross-functional teams to enable integrated program planning and execution.
• Maintain relationships with external stakeholders to advance program and organizational objectives.
• Ensure compliance with regulatory requirements and quality standards, providing leadership during audits and inspections.

Senior Clinical Lead – Clinical Operations Job Requirements

• Bachelor’s degree in a scientific or health-related discipline required; advanced degree preferred.
• Fifteen or more years of clinical operations experience, including global program leadership.
• Seven or more years of leadership experience, including managing senior professionals and developing organizational capability.
• Proven expertise in portfolio governance, risk management, and vendor performance management.
• Strong business and financial acumen with experience in budgeting and forecasting.
• Exceptional communication skills, with the ability to influence across organizational levels.
• Proficiency with clinical technology platforms and Microsoft 365 applications.
• Experience with regulatory submissions and inspections is strongly preferred.
• Willingness to travel domestically and internationally as required.