VP, Global Clinical Operations

Role Summary

The Vice President, Global Clinical Operations (VP, GCO) is a senior leader responsible for leading Telix’s global clinical operations strategy and execution across the company’s diagnostic and therapeutic radiopharmaceutical portfolio. This role oversees operational planning, program delivery, vendor and site management, and inspection readiness to ensure high-quality, compliant, efficient clinical trial execution across all phases (Phase I–IV, including expanded access and registries). The VP, GCO partners with Clinical Development, Medical Affairs, Regulatory Affairs, CMC, Manufacturing/Supply Chain, and Commercial to enable timely development and global registration, while maintaining excellence in governance, patient safety, and financial stewardship across regions.

Responsibilities

• Leadership and Operational Oversight: Provide leadership and direction to Global Clinical Operations; develop and communicate department vision and goals.
• Operational Strategy: Develop and implement strategies for company-sponsored clinical trials, drive process improvements, and lead risk assessment across the portfolio.
• Team Management and Development: Lead and develop Clinical Operations teams, establish SOPs and governance, and foster collaboration and continuous improvement.
• CRO, Vendor & Performance Management: Oversee CRO/vendor selection, contracting, onboarding, governance, and performance; ensure quality, timelines, enrollment, TMF, monitoring, site engagement, and budgets.
• Site & Investigator Engagement: Build relationships with global investigators and sites; oversee onboarding, training, and communication to optimize enrollment.

Tactical

• Trial Execution and Oversight: Manage end-to-end Telix-sponsored trials, from feasibility to close-out, ensuring compliance with GLP, ICH, GCP, and local regulations.
• Stakeholder Collaboration: Coordinate with regulatory, medical, manufacturing, and other functions; maintain external relationships with CROs and sites.
• Inspection & Quality Excellence: Ensure inspection readiness; oversee TMF health, monitoring, deviations, CAPA, and regulatory inspections readiness.
• Resource Allocation and Budgeting: Allocate resources and manage the operating budget for clinical trials.
• Risk Management: Identify and mitigate risks to timelines, budget, and quality; implement contingency plans.
• Regulatory Compliance: Stay current with regulatory requirements; address non-compliance and drive continuous improvement.

Leader Of People

• Promote Telix values and foster quality, governance, and compliance within the team; ensure proper training and development.
• Support well-being and retention of top talent to meet business objectives.

Education

• Bachelor’s degree required; Advanced degree in life sciences, pharmacy, nursing, or related field strongly preferred

Qualifications

• 15+ years of Clinical Operations experience in the pharmaceutical/biotech industry or equivalent, including 7+ years in senior leadership roles
• Experience in oncology required; radiopharmaceutical or imaging-based studies strongly preferred
• Extensive experience in managing and leading teams; strong knowledge of region-specific trial regulations and GCP
• Proven track record leading Phase I–IV trials, regulatory submissions, and cross-functional collaboration
• Excellent negotiation, communication, and interpersonal skills; ability to build relationships with diverse stakeholders
• Self-motivated, goal-oriented, and able to work independently or with cross-functional teams
• Willingness to travel domestically and internationally as needed

Skills

• Leadership and strategic thinking
• Operational excellence and process improvement
• CRO/vendor management and governance
• Risk management and problem solving
• Regulatory compliance knowledge (GCP, GLP, ICH)
• Stakeholder management and cross-functional collaboration
• Effective communication and negotiation

Additional Requirements

• Willingness to travel domestically and internationally, as needed