Associate Director, Cell Therapy Patient Operations Processes, Standards, and Excellence

Are you ready to turn innovative cell therapy science into reliable, patient-ready operations that scale? In this role, you will shape how patients safely and seamlessly move through the cell therapy journey—from apheresis to administration—by building the standards and processes that teams and treatment centers rely on every day. Your work will help reduce operational risk, speed study execution, and enable patients to access life-changing medicines sooner. You will join a focused oncology team with the ambition to prevent cancer from taking more lives. Working across clinical and commercial programs, you will lead the development of practical, compliant, and scalable operational standards that bring consistency to complex workflows across diverse sites and healthcare settings. Can you align cross-functional teams behind clear, high-quality standards and ensure every site is ready on day one? Accountability Standards and Documentation Develop, author, review, and maintain fit-for-purpose standards, processes, manuals, site-facing forms, and training materials that enable safe, compliant, and effective patient operations and clinical product administration. Subject Matter Expertise Serve as the internal SME for cell therapy field and patient operations, including product handling and administration practices, ensuring consistent, lifecycle‑appropriate execution at treatment centers. Cross‑Functional Integration Partner with Patient Operations, Clinical Operations, Clinical Development, Quality, Manufacturing, Supply Chain, Medical, and Regulatory to define, implement, and sustain robust operational standards and center‑facing documentation across the end‑to‑end patient journey. Study and Commercial Readiness Support study startup, ongoing execution, and commercial readiness by making sure patient operations processes, administration requirements, and product handling documents are clear, consistent, and delivered to timeline. Process Excellence Lead and contribute to initiatives that improve execution quality, scalability, and consistency across cell therapy clinical operations, with a focus on patient journey coordination and site readiness. Issue and Quality Support Provide expert support during issue resolution and quality events, including clinical incidents, operational deviations, inspections, audits, and root cause analyses related to patient operations and administration practices. Protocol and Materials Review Review protocols and study‑level operational materials to align with cell therapy patient operations requirements, administration standards, technical constraints, and guidelines. Training and Enablement Train and support internal study teams and site‑facing functions on patient coordination, product care, office management practices, and operational standards; support or conduct site training as needed. Expert Review and Governance Act as an expert reviewer for study support materials and operational documentation that reference patient operations, product handling, administration, or key patient journey achievements. Continuous Improvement and Knowledge Sharing Capture lessons learned, identify process gaps, and embed standards across the cell therapy portfolio to drive ongoing improvement and organizational learning. Essential Skills/Experience Bachelors in related scientific, clinical, or healthcare profession, or equivalent Minimum 5 years of experience in hematology, oncology and/or autoimmune including autologous and allogeneic cell therapy workflows Extensive experience in development and implementation of SOPs, Manuals, Guidelines, and training documents/modules for cellular therapies in clinical research, treatment center, clinical development, patient operations, or related pharmaceutical/biotech functions. Experience working across a global matrix environment, partnering with cross‑functional teams such as Patient Operations, Clinical Operations, Clinical Science, Manufacturing, Supply Chain, Quality, and Medical. Strong knowledge of clinical trial design, GCP principles, drug development, and operational execution requirements in complex clinical studies. Demonstrated ability to translate technical concepts into clear operational processes and standards that are practical for study teams and investigational sites. Excellent written and verbal communication skills, with the ability to explain highly technical information clearly to a range of audiences. Strong problem‑solving, judgment, and organizational skills, with the ability to lead complexity and influence across functions. Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint. Desirable Skills/Experience Advanced degree in related scientific, clinical, or healthcare profession, or equivalent Minimum 3 years of experience in hematology, oncology and/or autoimmune including autologous and allogeneic cell therapy workflows Experience with site training, study startup, and patient journey design/execution in complex clinical trials. Ability to work in an environment of remote collaborators. Integrity and high ethical standards. Good conflict leadership skills and ability to handle crisis. Good intercultural awareness. Experience supporting or contributing to deviation management, inspection readiness, audit support, quality events, and process improvement initiatives. Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. #J-18808-Ljbffr AstraZeneca GmbH