(Sr) Manager, Patient Scheduling – East Coast

at  Autolus Ltd

The Senior Manager/Manager Patient Scheduling and Logistics will execute a strategy and deliver on goals which enable clinical study and commercial delivery. Responsibilities include executing the clinical study coordination and scheduling of patients and their cells, (apheresis starting material and drug product), from treatment site to Autolus manufacturing. Success in this role will require considerable initiative and proactivity to work within established processes and across dynamic patient journeys. Meeting these responsibilities will require close collaboration between the post holder treatment sites and internal Autolus functions including Manufacturing, Supply Chain, Quality, Clinical, Logistics, Commercial Operations and Medical to ensure that each patient visit and their CAR T-cells are coordinated seamlessly and effectively through their cell journey.
The Senior Manager/Manager Patient Scheduling and Logistics will collaborate with department members and key stakeholders to achieve objectives in addition to function as part of the Patient, Cell and Logistics Management (PCLM) team within Product Delivery and Operations.

Key Responsibilities

• Execute Patient Scheduling and Logistics strategy to realize Autolus clinical and commercial goals.
• Cross-train to manage patient cell journeys in both the clinical trial and commercial settings, developing expertise in the tools and systems employed.
• Act as the interface and lead between sites, clinical study team, case management, manufacturing, logistics and clinical operations to ensure smooth scheduling and coordination of both patients and cells.
• Coordinate and or manage patient scheduling and cell management tasks from:
• Patient consent and screening
• Confirming apheresis and subsequent dispatch to manufacturing
• Setting Courier pick-ups and deliveries as well as pre-alerts
• Oversee courier milestones, address changes to plan, escalate accordingly
• Confirming to treatment site successful product manufacturing & coordinating patient visits preparation prior to infusion (chemotherapy conditioning)
• CAR T-cell Drug Order form to clinical trial site & confirming receipt by clinical site
• Coordinating and overseeing of the final drug product (CAR T) to the treatment site and successful product infusion to the patient
• Identify and resolve issues or barriers which impact scheduling, logistics and coordination execution.
• Maintains patient confidentiality and adheres to all relevant Data Protection requirements.
• Use relevant tools and communication with treatment sites to optimize patient recruitment and slot utilization.
• Assist peers and colleagues in understanding, supporting and executing cell journey processes.
• Communicate study requirements to the clinical sites, while ensuring adherence to the cell journey process.
• Lead initiatives which continuously refine and improve the cell journey process including the screening/enrolment of trial patients, patient scheduling and treatment process.
• Executes to achieve performance metrics and reach goals. Analyze metrics to make decisions, take action, inform management etc.
• Proactively identifies potential study issues/risks and recommends/implements solutions.
• Work with multiple internal and external stakeholders, including vendors, to communicate detailed timelines and ensure performance expectations are met.
• Act as a functional expert for the “Cell Management Portal”.
• Ensure compliance to GxP including ICH GCP guidelines and regulations across the treatment sites and ensures Inspection Readiness at all times.
• Participate and or lead the development, review and implementation of departmental SOPs and processes.
• Attend internal and external team meetings, as scheduled and necessary.
• Travel up to 25% of working time to EU and US sites.

• Execute Patient Scheduling and Logistics strategy to realize Autolus clinical and commercial goals.
• Cross-train to manage patient cell journeys in both the clinical trial and commercial settings, developing expertise in the tools and systems employed.
• Act as the interface and lead between sites, clinical study team, case management, manufacturing, logistics and clinical operations to ensure smooth scheduling and coordination of both patients and cells.
• Coordinate and or manage patient scheduling and cell management tasks from:
• Patient consent and screening
• Confirming apheresis and subsequent dispatch to manufacturing
• Setting Courier pick-ups and deliveries as well as pre-alerts
• Oversee courier milestones, address changes to plan, escalate accordingly
• Confirming to treatment site successful product manufacturing & coordinating patient visits preparation prior to infusion (chemotherapy conditioning)
• CAR T-cell Drug Order form to clinical trial site & confirming receipt by clinical site
• Coordinating and overseeing of the final drug product (CAR T) to the treatment site and successful product infusion to the patient
• Identify and resolve issues or barriers which impact scheduling, logistics and coordination execution.
• Maintains patient confidentiality and adheres to all relevant Data Protection requirements.
• Use relevant tools and communication with treatment sites to optimize patient recruitment and slot utilization.
• Assist peers and colleagues in understanding, supporting and executing cell journey processes.
• Communicate study requirements to the clinical sites, while ensuring adherence to the cell journey process.
• Lead initiatives which continuously refine and improve the cell journey process including the screening/enrolment of trial patients, patient scheduling and treatment process.
• Executes to achieve performance metrics and reach goals. Analyze metrics to make decisions, take action, inform management etc.
• Proactively identifies potential study issues/risks and recommends/implements solutions.
• Work with multiple internal and external stakeholders, including vendors, to communicate detailed timelines and ensure performance expectations are met.
• Act as a functional expert for the “Cell Management Portal”.
• Ensure compliance to GxP including ICH GCP guidelines and regulations across the treatment sites and ensures Inspection Readiness at all times.
• Participate and or lead the development, review and implementation of departmental SOPs and processes.
• Attend internal and external team meetings, as scheduled and necessary.
• Travel up to 25% of working time to EU and US sites