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.
Responsibilities
- 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.
- Operational Strategy: Develop and implement the operational strategy for trial execution, implementation, monitoring, analysis, data delivery, and clinical dossiers for regulatory submission. Drive process improvements and efficiencies to optimize the conduct of clinical trials. Ensure that operational strategies are realistic, executable, and based on validated assumptions, including screen failure rates, recruitment feasibility, radioactive sample logistics, central/local testing needs, site capabilities, vendor capabilities, and local country constraints.
- CRO and Vendor Oversight: Provide strong sponsor oversight of CROs and vendors involved in trial conduct, either through the CRO or directly through the Company. Review CRO and vendor capabilities to determine whether they add value to Company processes and whether they have the experience required for radiopharmaceutical / RPT studies. Ensure CROs and vendors are selected not solely on line-item quote alignment but also on their demonstrated ability to execute the required work. Challenge vendor assumptions, budgets, timelines, change orders, staffing, and operational plans.
- Specialty Vendor Capability Assessment: Assess and oversee specialty vendors required for radiopharmaceutical clinical trials, including CROs, central laboratories, specialty couriers, radiopharmaceutical logistics vendors, imaging vendors, dosimetry vendors, local laboratories, gamma counter providers, nuclear medicine support vendors, and sample handling vendors. Ensure vendors have appropriate SOPs, infrastructure, experience, documentation, and qualified personnel to support radioactive drug and hot sample logistics.
- Country and Site Execution Oversight: Provide oversight of country-specific and site-specific execution risks, including local regulatory requirements, radiation safety rules, import/export restrictions, site nuclear medicine capabilities, sample shipment feasibility, local laboratory options, investigator/site readiness, and local team input. Ensure that local experts, country leads, site staff, and sponsor team concerns are heard, documented, assessed, and escalated appropriately.
- Local Versus Central Analysis Strategy: Ensure that local versus central analysis decisions are evaluated early from an operational, regulatory, QA, data integrity, budget, and timeline perspective. For radioactive blood/urine or other hot patient samples, ensure early assessment of whether samples should be shipped centrally or analyzed locally, including use of local laboratories, on‑site gamma counters, site-based testing, comparability controls, data transfer requirements, and appropriate QA oversight.
- Hot Sample Logistics Oversight: Ensure appropriate planning and oversight for collection, processing, storage, packaging, shipment, receipt, analysis, and documentation of radioactive blood, urine, or other patient samples. Confirm that actual radioactivity levels, shipment classification, packaging/container requirements, courier capabilities, country-specific requirements, and cost assumptions are validated before finalizing study budgets or operational plans.
- Budget and Resource Allocation: Allocate resources effectively and efficiently to support the successful execution of clinical trials. Develop and manage the function's budget, ensuring optimal utilization of resources. With Project Management and Finance, ensure clinical trial budgets reflect realistic assumptions for RPT studies, including screen failure rates, radioactive drug supply, hot sample logistics, imaging/dosimetry, nuclear medicine site readiness, monitoring needs, local testing options, vendor scope, and country‑specific operational complexity.
- CRO SOW and Change Order Review: Review CRO scopes of work, study task lists, vendor budgets, and change orders to ensure they are based on realistic and validated operational assumptions. Challenge CRO and vendor change orders when costs appear to result from poor planning, incorrect assumptions, lack of experience, and failure to identify RPT‑specific requirements upfront. Ensure budget risks and cost drivers are escalated with clear
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