Want to know if this job is worth applying to?
Remote, Oregon, United States
Remote only
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
Reporting to the Senior/ Director, Clinical Operations, the ADCO will ensure clinical stage programs meet objectives within timelines, budget, and quality standards. This involves operational planning and execution of clinical studies, ensuring compliance with GCP, ICH guidelines, regulatory requirements, and Telix’s SOPs. The ADCO will collaborate closely with teams in Clinical, Data Management, Medical Writing, Biostatistics, CMC, Pharmacovigilance, Regulatory, and Program Management, as well as CROs, to execute studies on time and within budget. The ADCO is accountable for operational planning and execution at the study level with responsibility for clinical study plan and execution (from planning start-up, conduct, reporting and close out) including timeline, quality and budget. The ADCO will also provide leadership and line management to their team, ensuring effective performance and development.
The ADCO will provide leadership in global subject/patient recruitment plans, communicate with key study PIs, oversee CRO/vendor management, and develop KPIs in collaboration with the clinical team. They will also create contingency/risk management plans and assist the Senior/ Director of Clinical Operations in development strategies. Additional duties include supporting clinical project managers, clinical trial assistants, interfacing with various departments, and providing variance analysis of budget to actual costs. The ADCO will lead the management and execution of all clinical trials with a clinical program. This includes but is not limited to, ensuring cost, quality and timeliness of multiple programs is met (depending on the program scope, the ADCO may still have direct trial management responsibilities).
Key Accountabilities:
• Oversees the management of clinical trials from their inception to completion, expertly guiding both internal and external multidisciplinary teams
• Leads and manages integration of all project team activities, leveraging internal and development partner resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge
• Manages performance, development and growth of junior staff to support and guide them to improved efficiency and effectiveness at prioritization and problem solving, highly experienced as a line manager
• Drives the review and completion of all study-related plans and systems according to timelines and standards.
• Effectively communicate and interact with study PIs, as required.
• Manage and oversee aspects of CRO/vendor identification/procurement, request for proposal submission, CRO selection, and the day-to-day operational management activities of CROs, development of Key performance Indicators (KPIs), management of global resources, expertise, and knowledge within the CRO/vendor, in collaboration with CPMs.
• Participate in Case Report Form design, user acceptance testing in partnership with data management
• Lead the development of contingency/risk management plans for projects and assist Sr Director/Director of Clinical Operations in the preparation and execution of sound development strategies
• Provide support to clinical project managers within and/or across programs
• Assist in preparing budgets, study timelines, and forecasts in collaboration with Sr. CPM/CPM for Sr Director/Director of Clinical Operations approval
• Maintain rigorous compliance with study plans, monitoring clinical studies through direct communication with CROs and investigator sites
• Strategically plan and coordinate with cross-functional teams for optimal execution of clinical trials
• Identify potential study issues, formulating proactive contingency plans
• Mentor team members and manage direct reports, fostering professional growth
• Participates in the development and review of the protocol and informed consent to provides an operational feasibility perspective and confirm clarity of procedures
Key Capabilities:
At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.
Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
