Associate Director - Clinical Operations

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.
• 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

Education & Experience:

• Bachelor’s degree in health science or related field is required. An advanced degree in a scientific discipline is preferred.
• 6+ years of clinical research experience gained with a Biotechnology or Pharmaceutical Company working on all stages (Phase 1-4) multinational clinical studies.
• 4+ years clinical project management experience with global clinical studies.
• Experience in oncology, nuclear medicine and/or radiopharmaceuticals trials preferred.
• Proven experience in effectively leading teams and managing direct reports preferred.
• Demonstrated knowledge of ICH guidelines, GCP, and global regulatory requirements for clinical trials.
• Must understand clinical development processes and the interdependencies of various tasks that require coordination among asset team, functional/regional team members and third parties
• Proven ability and experience with coaching others
• Ability to embrace the diversity of thought to model innovative behaviors (e.g., reaching across boundaries, inspire and empower others and lead decisively in the midst of ambiguity)
• Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability.
• Excellent communication (written and verbal) and presentation skills along with leadership qualities
• Advanced skills in Microsoft Office Suite and a keen eye for detail. Proven ability to collaborate effectively both internally and externally. Experience in facilitating project team meetings and ensuring stakeholder alignment
• Advance skills in Veeva Vault, and various EDCs (i.e., Medidata RAVE, Viedoc etc).

Key Capabilities:

• 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