Clinical Manager

Job Title: Associate Director, Apheresis and Infusion Operations Location: United Kingdom Company Overview: We are a cutting-edge CAR-T biotechnology company at the forefront of cellular therapy innovation. Our mission is to deliver life-changing treatments to patients with serious unmet medical needs. We are seeking a dynamic and experienced Associate Director for Apheresis and Infusion Operations to join our growing team in the UK. Role Overview: The Associate Director, Apheresis and Infusion Operations, will play a pivotal role in overseeing the end-to-end processes of apheresis and infusion for CAR-T therapies. This role requires leadership in building and managing robust operational workflows, ensuring compliance with regulatory standards, and maintaining excellence in patient and clinical site support. The successful candidate will work cross-functionally with clinical, manufacturing, quality, and regulatory teams to ensure seamless execution of these critical operations. Key Responsibilities Operational Leadership Develop, implement, and manage operational strategies for apheresis and infusion activities across the UK. Build and maintain strong relationships with apheresis and infusion sites to ensure smooth operations and patient care. Serve as the primary point of contact for site operations, addressing challenges and ensuring adherence to timelines. Establish and maintain contracts with apheresis and infusion centers, ensuring service quality and efficiency. Process Management Oversee the collection, handling, and transport of patient cells to manufacturing facilities. Collaborate with logistics and supply chain teams to ensure timely delivery of CAR-T products to infusion centers. Ensure standard operating procedures (SOPs) are implemented and followed at all sites. Work closely with manufacturing teams to align schedules and capacities. Regulatory Compliance and Quality Assurance Ensure compliance with GxP, MHRA, and other applicable regulatory standards. Collaborate with Quality Assurance teams to address deviations and implement corrective actions. Conduct regular audits and inspections of apheresis and infusion sites. Training and Support Provide education and training to clinical site staff on apheresis and infusion processes. Serve as a subject matter expert (SME) for internal and external stakeholders. Address real-time issues at clinical sites, ensuring patient safety and product quality. Cross-Functional Collaboration Partner with Clinical Operations, Medical Affairs, and Commercial teams to align apheresis and infusion activities with broader company goals. Support the implementation of new clinical trials or commercial launches involving CAR-T therapies. Qualifications and Skills Education and Experience Advanced degree in life sciences, nursing, pharmacy, or a related field (e.g., MSc, PhD, PharmD, or equivalent). Minimum of 8–10 years of experience in apheresis, infusion, or cellular therapy operations, preferably in a biotech, pharmaceutical, or clinical setting. Demonstrated expertise in CAR-T or other advanced therapies is highly desirable. Technical and Professional Skills Deep understanding of apheresis and infusion procedures, including regulatory and quality requirements. Proven ability to manage complex workflows and cross-functional operations. Experience working with clinical trial and commercial operations. Strong project management skills and the ability to handle multiple priorities. Personal Attributes Excellent interpersonal and communication skills, with the ability to build strong relationships with internal and external stakeholders. Strategic thinker with strong problem-solving capabilities. Detail-oriented and capable of maintaining high-quality standards under pressure. Willingness to travel within the UK and internationally as required. What We Offer Competitive compensation and benefits package. The opportunity to make a meaningful impact in the lives of patients. A collaborative and innovative work environment. Professional growth and development opportunities in a fast-evolving industry.