Senior Clinical Lead – Clinical Operations

Greenkey Resources LLC; United States; Remote; USD 180,000 - 260,000; Full time

Job summary

Green Key Resources LLC is seeking a Senior Clinical Lead – Clinical Operations to direct global programs from early development through registration. You will drive strategic direction, build scalable plans, and oversee data quality, timelines, and budgets across development phases.

You will manage governance, vendor relationships, and cross-functional collaboration, ensuring regulatory submissions and inspections readiness while traveling as required.

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• 15+ years of clinical operations experience with global program leadership.
• 7+ years in leadership, including senior professionals management.
• Proven expertise in portfolio governance, risk management, and vendor performance management.
• Strong business and financial acumen with budgeting/forecasting experience.
• Exceptional communication skills to influence across levels.
• Experience with regulatory submissions and inspections is preferred.
• Willingness to travel domestically and internationally as required.

Responsibilities

• Set the vision and priorities for global Clinical Operations in line with corporate objectives.
• Ensure delivery of quality data within timelines, budgets and risk parameters through executive oversight.
• Develop integrated global operational strategies, including resource models and milestones.
• Establish governance frameworks, standards, and performance measures for 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 objectives.
• Ensure compliance with regulatory requirements and quality standards; lead audits and inspections.

Skills

Strategic leadership

Clinical operations leadership

Budgeting & forecasting

Vendor management

Regulatory submissions & inspections

Cross-functional collaboration

Executive communication

Program governance

Travel flexibility

Education

Bachelor’s degree in science or health-related field

Advanced degree (MD/PhD/MPH/MBA) preferred

Tools

CTMS

Microsoft 365

Job description

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.