Associate Director, Clinical Operations

Telix Pharmaceuticals (AMER)

1d•Hybrid

About The Position

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. 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).

Requirements

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
Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to 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
Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills

Responsibilities

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
Contributes to ongoing department infrastructure development efforts such as SOP development, implementation and/or innovation of new processes for assigned studies within the department.
Oversees study budget, investigator and vendor contracts, budgets, and payments, reviews accruals on a regular basis.
Provides oversight for the setup, maintenance, and close-out of the Trial Master File and ensures it is complete and audit ready.
Supports audit/inspection activities as needed.
Maintain a state of inspection readiness for clinical development inclusive of TMF.
Partner with regulatory and medical to ensure safety management and monitoring processes are implemented
Initiate clinical change control process for studies, as appropriate
Embrace an organizational culture that fosters diversity, equity, and inclusion
Perform additional duties as required by the evolving needs of the organization