Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated
Kyverna is recruiting a highly motivated Senior Manager of Patient Operations responsible for the Coordination of the Patient Journey including Planning and Scheduling for all patient scheduled activities from leukapheresis to administration of the cell product. The ideal candidate will contribute to our goals of navigating what’s next in synthetic biology, immunology and cell engineering while living our core values: Bring Intellectual Rigor, Elevate Each Other, and Stay True To Why.
The Senior Manager, Patient Operations will be responsible for the planning and integration of trial-specific scheduled activities involving patient visits and procedures from cell collection through cell product administration as the program requires. This role will collaborate closely with all stakeholders along the patient’s journey, including Medical, Clinical Operations, Supply Planning and Scheduling, Logistics, Manufacturing and the Clinical Sites to ensure robust communication of dates, proposed changes to the schedule, and status. Provides strategic input to planning, forecasting and monitoring of patient involvement and visits to ensure seamless connection from initial visit to treatment.
- Manages the interface of the clinical site regarding scheduling and coordination of cell collection, and receipt of cell product at the clinical site for administration.
- Collects, Manages and communicates the plan and forecast for patient visits associated with the studies in conjunction with supply planning and clinical program plans.
- Ensures the clinical site has processes and is trained on trial-specific requirements for Cell Product receipt, storage, reconciliation, and Chain-of-Identity confirmation according to Kyverna established requirements.
- Ensures the clinical site has the required equipment for product handling and administration, and that any alternatives are endorsed for use by Kyverna Therapeutics.
- Works with the clinical site and the apheresis center to establish and manage updates to trial-specific scheduling and communicates with Kyverna medical team members and clinical site the initiation points for pre-administration activities.
- For cell collection: Ensures timing and completion of screening, IDM testing, apheresis scheduling.
- For cell administration: Ensures timing and communication to stakeholders of washout start, lymphodepletion start, any re-screening start.
- Manages, Communicates, and Assesses impact to overall schedule of changes to patient visits (screening, apheresis, lymphodepletion, etc.)
- In collaboration with Kyverna Medical, Clinical Operations and the clinical sites, communicate requested changes in the schedule and work with Supply Chain and Logistics to confirm that proposed changes can be accommodated.
- Communicates issues that impact the patient-related scheduling to the relevant stakeholders and actively contributes to the resolution (e.g. patient criteria that needs Technical Operations to assess impact to overall process, or Technical issue that needs Medical Director to assess impact to patient).
- Coordinates the communication of patient status and delivery of data/results to ensure seamless progression of the process.
- Acts as emergency contact for clinical sites during the preparation for administration of the cell product and addresses and escalates any issues that may arise.
- Compiles and maintains a FAQ for the collection and administration processes and requirements.
- Provides strategic input into improving the operations associated with the patient and trial-specific activities.
- Collaborate with stakeholders to ensure robust management and seamless integration of the patient-scheduled visits with the rest of the patient journey, from cell collection through receipt of cell product for administration.
- Bachelor’s Degree in life sciences field with minimum 10 years of experience in a regulated environment either hospital or pharmaceutical/biotech or apheresis and/or cell therapy operations management
- Experience working in Cell Therapy, Apheresis or Stem Cell Transplant programs essential.
- Experience working in Patient Operations in a cell