Telix Pharmaceuticals Limited je biofarmacevtsko podjetje v komercialni fazi, ki razvija in trži teranostične radiofarmacevtike za zdravljenje raka in redkih bolezni. Njegov pristop združuje ciljno usmerjeno slikanje z zdravljenjem na osnovi sevanja ter tako podpira bolj informirano klinično odločanje in personalizirano oskrbo.
Razvojni program podjetja zajema raka prostate in ledvic, nevroonkologijo ter mišično-skeletne rake. Družba Telix je pridobila globalna regulativna dovoljenja za svoj vodilni izdelek za slikanje Illuccix® in še naprej razvija obsežen program kliničnih preskušanj po vsem svetu. Njena ekipa deluje na področju zdravstva, biotehnologije in sorodnih komercialnih področij ter inovacije na področju radiofarmacevtikov prenaša iz razvoja v klinično uporabo.
Associate Director, Clinical Operations (Remote, US)
Lead global clinical-trial operations at Telix Pharmaceuticals, a radiopharmaceutical company focused on precision medicine. Oversee studies, CROs, budgets, compliance, and clinical operations teams.
Opis
- Keep clinical-stage programs on track for their objectives, timelines, budgets, and quality standards.
- Plan and deliver clinical studies from startup through conduct, reporting, and close-out.
- Coordinate project-team work across internal teams, development partners, and CROs.
- Oversee clinical trials throughout their lifecycle.
- Lead and manage clinical operations staff.
- Develop global participant recruitment plans and communicate with study principal investigators.
- Manage CRO and vendor relationships and establish key performance indicators.
- Develop contingency and risk-management plans.
- Support clinical project managers across programs.
- Prepare study budgets, timelines, forecasts, and variance analyses.
- Track study progress through regular communication with CROs and investigator sites.
- Coordinate cross-functional teams to support effective trial delivery.
- Review and complete study plans and systems.
- Contribute to Case Report Form design and user acceptance testing.
- Help develop protocols and informed-consent materials, assessing operational feasibility.
- Oversee study budgets, contracts, payments, and accruals.
- Maintain the Trial Master File and keep studies inspection-ready.
- Support audits and inspections.
- Work with regulatory and medical teams on safety management and monitoring.
- Initiate clinical change-control processes.
- Contribute to SOP development and improvements to departmental infrastructure.
Zahteve
- Experience leading and managing clinical trials across their lifecycle.
- Experience planning and executing clinical studies.
- Knowledge of GCP and ICH guidelines.
- Knowledge of regulatory requirements and company SOPs.
- Experience managing multidisciplinary internal and external teams.
- Experience identifying, procuring, and selecting CROs and vendors, and managing their operations.
- 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 setting up, maintaining, and closing out Trial Master Files and preparing for audits.
- Experience supporting audits and inspections.
- Experience with clinical change-control processes.
- Experience managing, mentoring, and developing staff.
- Ability to collaborate with Clinical, Data Management, Medical Writing, Biostatistics, CMC, Pharmacovigilance, Regulatory, Program Management, CROs, and other stakeholders.
- Strong communication and collaboration skills, adaptability, ethical conduct, and commitment to continuous learning.
Ugodnosti
- Annual performance-based bonus.
- Equity-based incentive program.
- Generous vacation allowance.
- Paid wellness days.
- Learning and development support.
- Hybrid and remote work arrangements.