Director, Clinical Operations - EMEA

See Yourself at Telix

The Director, Clinical Operations is responsible for providing strategic and tactical leadership and oversight of the Regional clinical operations function within Telix. In this role, the Director, Clinical Operations will lead a team of Clinical Operations professionals, 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.

Key Accountabilities:

• Leadership and Operational Oversight: Provide leadership and direction to the regional clinical operations function, ensuring alignment with Telix's overall program goals and objectives. Develop and regionally communicate the vision and goals for the department.
• Team Management and Development: Lead and manage a team of Clinical Operations professionals and functional consultants of Clinical Operations, providing guidance, mentorship, and support. Foster a culture of collaboration, innovation, and continuous improvement within the team.
• Trial Execution and Oversight: Oversee the regional 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.
• Operational Strategy: Develop and implement the operational strategy for regional trial execution, implementation, monitoring, analysis, data delivery, and clinical dossiers for regulatory submission. Drive process improvements and efficiencies to optimize the conduct of clinical trials.
• Stakeholder Collaboration: Collaborate closely with cross-functional program teams, including regulatory affairs, medical affairs, research and innovation, manufacturing, and other relevant departments, to ensure effective coordination and alignment in clinical trial activities. Foster strong relationships with external stakeholders, such as clinical research organizations (CROs) and investigative 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 regional 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 department.
• 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.

Education and Experience:

• An undergraduate degree in a relevant field is required. An advanced degree such as a Master's or Ph.D. in a relevant field is preferred.
• Extensive experience in clinical operations is essential, with 10+ years of operational experience is required.
• Previous experience in progressively responsible roles within clinical operations.
• Extensive experience in managing and leading teams, including 5+ years' experience in a leadership role within clinical operations is required.
• 8+ years of experience working in the therapeutic area of oncology is preferred.
• 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 departments 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.
• Strong leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively at all levels of an organization.

Key Capabilities:

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills