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

About the Role

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 ensures Phase I-IV clinical trials align 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.

Responsibilities

• Leadership and Operational Oversight:
  • Provide leadership and direction to the clinical operations function, aligning with Company goals.
  • Develop and communicate the vision and goals for the department.
  • Lead planning, start-up, conduct, oversight, and closeout of complex radiopharmaceutical/RPT clinical studies.
• Team Management and Development:
  • Lead and manage a team of Clinical Operations professionals, providing guidance and mentorship.
  • Foster a culture of accountability, collaboration, innovation, and continuous improvement.
  • Develop staff in areas including CRO oversight, vendor management, RPT-specific trial execution, and cross-functional leadership.
• Trial Execution and Oversight:
  • Oversee clinical trial execution in compliance with GLP, ICH guidelines, GCP, and local regulations.
  • Monitor trial progress, identify risks, and implement mitigation strategies.
  • Ensure oversight of site activation, patient recruitment, monitoring, data delivery, and study closeout.
• Radiopharmaceutical / RPT Operational Oversight:
  • Ensure radiopharmaceutical-specific operational requirements are identified, planned, and executed.
  • Manage radioactive drug supply, nuclear medicine site readiness, radiation safety, imaging, dosimetry, and specialty logistics.
• Operational Strategy:
  • Develop and implement operational strategies for trial execution, monitoring, and regulatory submissions.
  • Drive process improvements and efficiencies in clinical trial conduct.
• CRO and Vendor Oversight:
  • Provide sponsor oversight of CROs and vendors, ensuring alignment with Company processes.
  • Assess vendor capabilities and challenge assumptions, budgets, and operational plans.
• Specialty Vendor Capability Assessment:
  • Oversee specialty vendors for radiopharmaceutical trials, ensuring compliance with SOPs and infrastructure requirements.
• Country and Site Execution Oversight:
  • Manage country-specific and site-specific execution risks, including regulatory and radiation safety requirements.
• Local Versus Central Analysis Strategy:
  • Evaluate local versus central analysis decisions for radioactive samples, considering operational and regulatory factors.
• Hot Sample Logistics Oversight:
  • Ensure planning and oversight for radioactive sample collection, shipment, and analysis.
• Budget and Resource Allocation:
  • Manage budgets and allocate resources for clinical trials, ensuring realistic assumptions for RPT studies.
• Stakeholder Collaboration:
  • Collaborate with cross-functional teams, including regulatory affairs, medical affairs, and alliance partners.
• Compliance and Quality Assurance:
  • Ensure compliance with regulations and implement quality assurance measures for trial conduct and data integrity.
• Risk Management:
  • Identify and mitigate risks impacting trial timelines, budget, quality, and regulatory submissions.
• Regulatory Compliance:
  • Stay updated on regulatory requirements and ensure adherence in clinical operations.
• Industry Engagement:
  • Stay informed on industry trends and represent the Company at relevant conferences.

Qualifications

• Bachelor's degree in life sciences, medicine, pharmacy, nursing, nuclear medicine, or related field; advanced degree preferred.
• 10–15 years of clinical operations experience, with 5+ years in radiopharmaceuticals.
• Proven leadership in clinical operations, including team management and cross-functional collaboration.
• Strong knowledge of GCP, ICH guidelines, and regional clinical trial regulations.
• Track record of successful clinical trial execution and regulatory submissions.
• Expertise in radiopharmaceutical trial conduct, including radioactive drug handling and radiation safety.