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 clinical trial phases (Phase I-IV including expanded access and registries) are managed and executed in alignment with Telix's overall program goals, timelines, budgets, and quality expectations. The VP, GCO partners closely with Clinical Development, Medical Affairs, Regulatory Affairs, CMC, Manufacturing/Supply Chain, and Commercial to enable timely development of Telix’s pipeline and support global registration efforts.

Responsibilities

• Leadership and Operational Oversight: Provide leadership and direction to the Global Clinical Operations function, ensuring alignment with Telix's overall program goals and objectives. Develop and communicate the vision and goals for the department.
• Operational Strategy: Develop and implement the operational strategy for Telix’s Company-sponsored clinical trial implementation, execution, monitoring, analysis, data delivery, and clinical dossiers for regulatory submission. Drive process improvements and efficiencies to optimize the conduct of clinical trials. Lead operational risk assessment and mitigation strategies across the portfolio.
• Team Management and Development: Lead and manage a team of Clinical Operations professionals and their respective teams and functional consultants of Clinical Operations, providing guidance, mentorship, and support. Establish SOPs, governance and metrics. Foster a culture of collaboration, innovation, and continuous improvement within the team.
• CRO, Vendor & Performance Management: Lead the end-to-end selection, contracting, onboarding, and performance oversight of CROs and critical vendors. Establish and maintain a formal CRO governance model including executive business reviews, KPIs, ongoing risk assessments, and performance scorecards. Ensure CRO accountability for quality deliverables, timelines, enrollment performance, TMF completeness, monitoring metrics, site engagement, and budget adherence. Drive escalation pathways and root cause analyses to address performance issues with urgency and transparency.
• Site & Investigator Engagement: Build strong, collaborative relationships with global KOLs, investigators, selected sites. Oversee operational feasibility, site onboarding, study training, and investigator communication to optimize enrollment performance and resourcing needs.
• Trial Execution and Oversight: Oversee end-to-end execution of Telix-sponsored clinical trials, including feasibility and site selection strategy, contracting, study start-up, monitoring, data collection, database lock, and study close-out. Ensure studies are conducted in accordance with GLP, ICH guidelines, GCP, local regulatory guidelines, laws, and relevant Company SOPs. Monitor trial progress, identify risks, and implement mitigation strategies.
• Stakeholder Collaboration: Collaborate closely with cross-functional Program teams, including regulatory affairs, medical affairs, research and innovation, manufacturing and other relevant functions, to ensure effective coordination and alignment in clinical trial activities. Foster strong relationships with external stakeholders, such as CROs and investigational sites.
• Inspection & Quality Excellence: Ensure the organization is standardized and consistently inspection-ready across all studies and vendors. Partner with Quality to oversee TMF health, monitoring oversight, protocol deviations, and CAPA. Lead operational responses and readiness for regulatory inspections (FDA, EMA, PMDA, MHRA, etc.).
• Resource Allocation and Budgeting: Allocate resources effectively and efficiently to support the successful execution of clinical trials. Develop and manage the function’s operating budget, ensuring optimal utilization of resources.
• Risk Management: Identify and mitigate risks and issues that may impact trial timelines, budget, or quality. Implement risk management strategies and contingency plans to minimize potential disruptions.
• Regulatory Compliance: Stay updated with the evolving regulatory landscape and ensure adherence to local and international regulatory requirements. Proactively address any compliance issues and drive continuous compliance improvement within the Clinical Operations function.

Qualifications

• Bachelor’s degree required; Advanced degree in life sciences, pharmacy, nursing, or related field strongly preferred
• 15+ years’ experience in Clinical Operations in the pharmaceutical/biotech industry or equivalent, including 7+ years in senior leadership roles
• Experience in oncology required; radiopharmaceutical or imaging-based clinical studies strongly preferred
• Extensive experience in managing and leading teams, including leadership roles within Clinical Operations
• Strong knowledge of region-relevant clinical trial regulations, guidelines, and industry standards (GCP and local regulations)
• Proven track record leading execution of clinical trials (Phase I-IV), regulatory submissions, managing multiple programs, and adherence to timelines, budgets, and quality
• Experience collaborating with regulatory affairs, medical affairs, finance, and R&D
• Broad experience in developing and implementing clinical operational strategies, processes, and best practices
• Experience in risk management, compliance, and quality assurance within clinical operations
• Ability to drive innovation, process improvement, and operational efficiencies in clinical trial execution
• Experience interacting with regulatory agencies during audits
• Excellent negotiation, communication, and interpersonal skills; ability to build relationships with diverse stakeholders
• Self-motivated, goal-oriented, able to work independently and in cross-functional teams
• Willingness to travel domestically and internationally as needed

Skills

• Inclusive mindset and collaboration
• Creativity, innovation, and commitment to excellence
• Results-oriented with focus on measurable outcomes
• Ethical behavior and integrity
• Adaptability and strong communication
• Team leadership and resilience
• Continuous learning and professional development