Associate Director – Clinical Operations

🔥 15 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 10%

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Telix Pharmaceuticals Limited

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2015

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Telix Pharmaceuticals Limited is a commercial-stage biopharmaceutical company dedicated to transforming the way cancer and rare diseases are diagnosed and treated. Focusing on the development and commercialization of theranostic radiopharmaceuticals, Telix utilizes targeted radiation to enhance treatment decision-making and deliver personalized therapy. With an extensive pipeline addressing areas such as prostate and kidney cancer, neuro-oncology, and musculoskeletal cancers, Telix has garnered global regulatory approvals for its lead imaging agent, Illuccix®, and is actively conducting numerous clinical trials worldwide.

📋 Description

• Ensure clinical-stage programs meet objectives within timelines, budget, and quality standards • Plan and execute clinical studies from startup through conduct, reporting, and close-out • Lead and manage integration of internal, development-partner, and CRO project-team activities • Oversee clinical trials from inception to completion • Provide leadership and line management to clinical operations staff • Develop global subject/patient recruitment plans and communicate with study principal investigators • Oversee CRO/vendor management and develop key performance indicators • Create contingency and risk management plans • Support clinical project managers within and across programs • Prepare budgets, study timelines, forecasts, and variance analyses • Monitor clinical studies through communication with CROs and investigator sites • Coordinate cross-functional teams for optimal clinical-trial execution • Review and complete study-related plans and systems • Participate in Case Report Form design and user acceptance testing • Contribute to protocol and informed-consent development from an operational feasibility perspective • Oversee study budgets, contracts, payments, and accruals • Maintain the Trial Master File and inspection readiness • Support audit and inspection activities • Partner with regulatory and medical teams on safety management and monitoring processes • Initiate clinical change-control processes • Contribute to SOP development and department infrastructure improvements

🎯 Requirements

• Experience and capability to lead and manage clinical trials across their lifecycle • Operational planning and execution of clinical studies • Knowledge of GCP and ICH guidelines • Knowledge of regulatory requirements and company SOPs • Experience managing multidisciplinary internal and external teams • CRO/vendor identification, procurement, selection, and operational management experience • Experience developing and managing KPIs • Experience with Case Report Form design and user acceptance testing • Experience developing contingency and risk management plans • Experience preparing budgets, study timelines, and forecasts • Experience overseeing investigator and vendor contracts, budgets, and payments • Experience with Trial Master File setup, maintenance, close-out, and audit readiness • Experience supporting audits and inspections • Experience with clinical change control processes • Experience providing line management, mentoring, and staff development • Ability to collaborate with Clinical, Data Management, Medical Writing, Biostatistics, CMC, Pharmacovigilance, Regulatory, Program Management, CROs, and other stakeholders • Strong communication, collaboration, adaptability, ethical behavior, and continuous learning capabilities

🏖️ Benefits

• Annual performance-based bonuses • Equity-based incentive program • Generous vacation • Paid wellness days • Support for learning and development • Hybrid and remote work arrangements