[Hiring] Associate Director, Clinical Operations @AMER

Role Description

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
• Collaboration with teams in Clinical, Data Management, Medical Writing, Biostatistics, CMC, Pharmacovigilance, Regulatory, and Program Management, as well as CROs
• Accountability for operational planning and execution at the study level
• Providing leadership and line management to their team

The ADCO will also:

• Provide leadership in global subject/patient recruitment plans
• Communicate with key study PIs
• Oversee CRO/vendor management
• Develop KPIs in collaboration with the clinical team
• Create contingency/risk management plans
• Assist the Senior/Director of Clinical Operations in development strategies
• Support clinical project managers and clinical trial assistants
• Provide variance analysis of budget to actual costs
• Lead the management and execution of all clinical trials

Qualifications

• Expertise in clinical trial management
• Strong leadership and team management skills
• Excellent communication skills
• Experience with CRO/vendor management
• Ability to develop and implement risk management plans

Requirements

• Oversees the management of clinical trials from inception to completion
• Leads and manages integration of all project team activities
• Drives the review and completion of all study-related plans and systems
• Effectively communicates and interacts with study PIs
• Manages performance, development, and growth of junior staff
• Participates in Case Report Form design and user acceptance testing
• Maintains rigorous compliance with study plans
• Strategically plans and coordinates with cross-functional teams
• Identifies potential study issues and formulates proactive contingency plans
• Mentors team members and manages direct reports
• Participates in the development and review of the protocol and informed consent
• Oversees study budget, investigator and vendor contracts, and payments
• Supports audit/inspection activities as needed
• Maintains a state of inspection readiness for clinical development
• Partners with regulatory and medical to ensure safety management
• Initiates clinical change control process for studies
• Embraces an organizational culture that fosters diversity, equity, and inclusion
• Performs additional duties as required by the evolving needs of the organization

Benefits

• Competitive salary
• Health and wellness programs
• Professional development opportunities
• Diverse and inclusive work environment

Company Description

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.