Car-t Cell Therapy Coordinator

Overall purpose of the role

The CAR-T Cell Therapy Coordinator (CTC) is responsible for facilitating the patient and the cell journey and ensuring they are synchronised. He/she is the main point of contact for the cell laboratory personal in treatment centres, which are critical stakeholder in the CAR-T journey. The CTC provides day to day support and case management to ensure smooth service delivery and facilitate cell logistics and a best-in-class customer experience through the CAR-T process.

Role description
- As member of the local CAR-T medical team, to make the link between commercial operations and medical affairs
- To support certified CAR-T sites on a patient-level, acting as the main point of contact for the cell therapy nurses and other relevant stakeholders (apheresis team, pharmacist, treating physician etc.)
- To facilitate the patient and the cell journey and ensure they are synchronised
- To provide day to day support and case management to ensure smooth service delivery and facilitate cell logistics
- To support the onboarding of the treatment site and relevant stakeholders on the order management IT platform
- To address special situations by routing to appropriate Janssen stakeholders
- Contributes to the Medical Leadership Team (MALTA) & Country Value Team (CVT) by sharing medical & operational CAR-T knowledge and insights from the field with the cross-functional team and herewith contributing to achieving aligned goals

Job responsibilities - Main activities / tasks

1. Local Medical Affairs team membership
- Act as a local CAR-T expert on CAR-T operations and logistics
- Direct any special situations to relevant local and regional stakeholders
- Ensure strong coordination with other MAF functions

2. Support to treatment centers for case management
- Supports the onboarding of the treatment site on the order management IT platform, ensuring the right stakeholders get the right information
- Collaborates with site stakeholders, especially nurse coordinator, apheresis team and pharmacist to coordinate all CAR-T related operations
- Supports patient enrolment by verifying completeness of information
- Assists the process from ordering, cell processing, cell transportation and delivery
- Collaborates with internal stakeholders to solve issues in ordering or manufacturing according to company policies
- Supports rescheduling and cancellations when needed
- Proactively communicates with sites, leveraging the IT platform, and addresses sites’ queries

3. Enable synchronisation of patient and cell journey
- Proactively checks and facilitates order processing by collaborating with Janssen stakeholders (Supply Chain, CAR-T centre of excellence, Customer service, CTAL)
- Coordinates cell pickup and delivery in collaboration with Supply Chain and based on site preferences
- Communicate frequently on cells status location and timelines
- Acts as primary point of contact with nurses for optimizing patient experience, e.g. provides patient materials as needed
- Liaises with Patient Engagement functions and supports local patient support programs where applicable
- Shares best practices on patient care coordination

4. Ensure positive customer experience
- Understands and adapts to customer preferences on ways of working such as mode and frequency of communication
- Collects and communicates issues / requests received from customer, coordinates triaging and resolution of issues related to day-to-day site operations, IT platform, patient journey or others
- Along with the CTAL, serve as point of contact for site for any logistics or operational issues and bring in additional resources until issue is resolved
- Organizes and provides (virtual) training for nurses on any relevant topic requested

5. Ensure operational performance and fulfilment of obligations
- Understands key supply chain processes, such as SC planning, delivery and enablement
- Confirms labelling and documentation requirements
- Coordinates with the CTAL and CAR-T EMEA COE to communicate site demands regarding manufacturing slot availability
- Ensures right information and support is provided for adverse event reporting
- Provide insights to COE lead and V2V lead into CAR-T operations to enable continuous improvement initiatives to cell collection and processing process

Accountabilities
- Be up to date with technical, medical and compliance-related training on CAR-T and myeloma
- Act in full compliance with relevant local and regional regulations and SOPs, in particular:

- Data privacy
- HCBI / promotional rules
- ATMP regulations
- Company SOPs
- PV
- Be ready to support any audit or inspection from local health authorities
- Support patient treatment by providing guidance and coordination with Janssen operations, verifying completeness and documentation of information, and addressing any unusual request by routing to local or regional stakeholders as needed
- Strong collaboration with local Cell Therapy Account Lead (CTAL)
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