Director, Clinical Operations (Melbourne)

Director, Clinical Operations (Melbourne)

25 Oct
|
Telix Pharmaceuticals
|
Melbourne

25 Oct

Telix Pharmaceuticals

Melbourne

Telix Pharmaceuticals is a dynamic, rapid-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases.

You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

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 compo

📌 Director, Clinical Operations (Melbourne)
🏢 Telix Pharmaceuticals
📍 Melbourne

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