See Yourself at Telix

The Vice President of Global Clinical Operations (VPGCO) is responsible for providing strategic leadership and oversight of Telix’s global clinical operations function. This role is a key senior leadership position, that will lead a team of Clinical Operations professionals, including the Senior Directors of Regional Clinical Operations and their respective teams, ensuring that Telix’s clinical studies (Phase I-IV) are managed and executed in alignment with Telix’s overall program goals, timelines, budgets, and quality expectations.

The VPCO will oversee and direct the execution and oversight of all clinical trials conducted by Telix, ensuring adherence to Good Laboratory Practice (GLP), ICH guidelines, Good Clinical Practice (GCP), and local regulatory guidelines, laws, and relevant company Standard Operating Procedures (SOPs). The VPGCO will play a crucial role in contributing to the achievement of Telix’s strategic goals by providing senior leadership, management, and development of the Clinical Operations function to ensure efficient outcomes for the Company’s clinical studies.

As the leader of the Global Clinical Operations function, the VPGCO will establish and drive the operational strategy for trial execution, implementation, monitoring, analysis, data delivery, and clinical dossiers for the primary purpose of regulatory submission(s). The VPGCO will work with the Chief Medical Officer to set the vision and goals for the Clinical Operations team and play a senior leadership role in strategic decision-making. In addition, the VPGCO will be responsible for developing and implementing best practices, resource allocation, budgeting and ensuring effective collaboration across cross-functional Program teams.

The VPGCO will represent the Global Clinical Operations function at the GLF level and collaborate closely with other functions such as regulatory affairs, medical affairs, and research and innovation to ensure the successful execution of clinical trials and Programs.

Key Accountabilities

Strategic:

•  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.
• 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. Foster a culture of collaboration, innovation, and continuous improvement within the team.
• Industry Engagement: Stay abreast of industry trends, best practices, and technological advancements in Clinical Operations. Represent Telix at relevant industry conferences, forums, and meetings to enhance the Company’s visibility and promote thought leadership.

Tactical:

•  Trial Execution and Oversight: Oversee the execution of clinical trials for Telix, ensuring they 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 clinical research organizations (CROs) and investigational sites.
• Compliance and Quality Assurance: Ensure compliance with applicable regulations, guidelines, and quality standards in all Clinical Operations activities. Implement quality assurance measures to maintain high standards of trial conduct, data integrity, and patient safety.
• 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 functions.

Leader of People:

•  Advocate for and instill within the Global Clinical Operations team the importance of Telix’s values: Everyone counts; we strive to be extraordinary; we act with determination and integrity.
• Demonstrate leadership for Telix’s quality, governance, and compliance systems through active promotion of standards and procedures and ensure that team members are suitably trained and developed to perform roles effectively and safely.
• Take an active interest in team members and their well-being, and endeavor to attract, develop and retain the best talent, to deliver Telix’s current and future business objectives. 

Position Requirements

Education:

• Bachelor’s degree in a Medical, Science, Pharmacology or relevant related field is required 
• Master’s degree or higher in a science and business field (e.g. MBA and PhD) is preferred.

Experience:

• 15+ years’ experience in Clinical Operations / Clinical Development within a pharmaceutical or biotechnology environment is required. 
• Experience within oncology and/or nuclear medicine is required.
• Previous experience in progressively higher responsibility roles within Clinical Operations, such as Director of Clinical Operations or equivalent is required.
• Extensive experience in managing and leading teams, including experience in a leadership role within Clinical Operations.
• Strong knowledge and understanding of region-relevant clinical trial regulations, guidelines, and industry standards, including GCP and applicable local regulations.
• Proven track record of successfully leading the execution of clinical trials (Phase I-IV), generating and compiling the clinical components of a regulatory submission, managing multiple programs, and ensuring adherence to timelines, budgets, and quality expectations.
• Expert in working with cross-functional teams and collaborating with other functions such as regulatory affairs, medical affairs, finance and research and development.
• Broad experience with the development and implementation of clinical operational strategies, processes, and best practices.
• Broad experience in risk management, compliance, and quality assurance within clinical operations.
• Demonstrated ability to drive innovation, process improvement, and operational efficiencies within clinical trial execution.
• Experience of interacting with regulatory agencies in preparation for, and during clinical audits.
• Excellent negotiation, communication, and interpersonal skills, with the ability to build and maintain relationships with diverse stakeholders.
• Self-motivated, goal-oriented, and able to work independently as well as collaboratively within cross-functional teams.
• Willingness to travel domestically and internationally, as needed.