Director ​/ Senior Director of Clinical Operations—Radiopharmaceutical ​/ RPT Programs

Overview

The Director / Senior Director, Clinical Operations provides strategic and operational leadership for the planning, execution, and oversight of the Company's global clinical development programs, with a primary focus on radiopharmaceuticals, radioligand therapies (RLT), and complex oncology studies. This role is responsible for ensuring Phase I-IV clinical trials are executed in alignment with program objectives, timelines, budgets, quality standards, regulatory requirements, and ICH-GCP.

The incumbent leads all aspects of clinical operations for radiopharmaceutical programs, including operational strategy, study execution, CRO and vendor management, resource planning, budgeting, and risk management. The role provides oversight of the unique operational requirements associated with radiopharmaceutical development, including radioactive drug supply, nuclear medicine site readiness, radiation safety, imaging and dosimetry, radioactive specimen collection and shipment, specialty laboratory coordination, and country-specific operational logistics.

As a senior clinical operations leader, this individual establishes operational strategies that support high-quality, inspection-ready clinical trials and timely regulatory submissions. The Director / Senior Director partners closely with executive leadership and cross-functional stakeholders—including Clinical Development, Regulatory Affairs, Medical Affairs, CMC, Drug Supply, Quality Assurance, Compliance, Finance, Legal, Project Management, and alliance partners to drive efficient execution across the clinical portfolio.

This role requires an experienced radiopharmaceutical clinical operations leader with the ability to proactively identify and mitigate operational risks, critically evaluate CRO and vendor performance, optimize study budgets and timelines, incorporate regional and site-level considerations, and deliver complex global clinical programs with a focus on quality, compliance, and executional excellence.

• Leadership and Operational Oversight: Provide leadership and direction to the clinical operations function, ensuring alignment with the Company's overall program goals and objectives. Develop and communicate the vision and goals for the department. Provide senior leadership for the planning, start-up, conduct, oversight, and closeout of complex radiopharmaceutical / RPT clinical studies, including studies involving radioactive drug administration, nuclear medicine sites, imaging/dosimetry, hot sample collection, and specialty logistics.
• Team Management and Development: Lead and manage a team of Clinical Operations professionals and functional consultants, providing guidance, mentorship, and support. Foster a culture of accountability, collaboration, innovation, continuous improvement, and proactive issue escalation. Develop Clinical Operations staff in areas including CRO oversight, vendor management, RPT-specific trial execution, budget review, risk management, site readiness, and cross-functional leadership.
• Trial Execution and Oversight: Oversee the execution of clinical trials for the Company, ensuring they are conducted in accordance with GLP, ICH guidelines, GCP, local regulatory guidelines, laws, radiation safety requirements, and relevant Company SOPs. Monitor trial progress, identify risks, and implement mitigation strategies. Ensure appropriate oversight of site activation, patient recruitment, screen failure assumptions, monitoring, data delivery, TMF quality, vendor performance, and study closeout.
• Radiopharmaceutical / RPT Operational Oversight: Ensure that radiopharmaceutical-specific operational requirements are identified, planned, budgeted, and executed appropriately. This includes radioactive drug supply, drug shipment, decay timing, site receipt, administration readiness, nuclear medicine department readiness, radiation safety approvals, hot lab capability, imaging/dosimetry requirements, gamma counter or local testing options, radioactive blood/urine sample handling, radioactive specimen collection and shipment, specialty laboratory coordination, and country-specific execution requirements.
• Operationa…