VP, Global Clinical Operations

AMER•Fishers, IN

About The Position

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 all aspects of 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. The individual ensures that Telix maintains excellence in clinical execution, operational governance, quality, patient safety, financial stewardship, and cross-functional alignment across all regions (North America, Europe, APAC, and Japan). The VP, GCO is accountable for the 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 VP, GCO 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.

Requirements

Bachelor’s degree required; Advanced degree in life sciences, pharmacy, nursing, or related field strongly preferred
15+ years’ experience in Clinical Operations experience in the pharmaceutical/biotech industry or equivalent experience including 7+ years in senior leadership roles required.
Experience in oncology required; radiopharmaceutical or imaging-based clinical studies strongly preferred.
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.
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

Responsibilities

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.
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.
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.
Lead the end-to-end selection, contracting, onboarding, and performance oversight of CROs (bandwidth of multiple trials) 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.
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.
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.
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.
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 corrective/preventative actions (CAPA).
Lead operational responses and readiness for regulatory inspections (FDA, EMA, PMDA, MHRA, etc.).
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.
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.
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.
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.