Vp, Global Clinical Operations
vor 7 Monaten
Telix Pharmaceuticals is a dynamic, fast-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 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 c
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