Senior Manager Global Patient Supply

FLSA Classification: Exempt/Salary 

Schedule: Monday to Friday; 8:00am to 5:00pm; On-site or Remote 

Department: Global Patient Supply  

Reports to: Senior Director Global Patient Supply  

Supervisory responsibilities: No 

Location: 13203 Murphy Road Suite 100 Stafford, TX 77477 

Position Summary/objective: 

The primary purpose of this Global Patient Supply (GPS) position is to ensure uninterrupted supply of Investigational Medicine and the related entities such as Leukapheresis and non- Investigational Medicinal Product (n-IMP) to the patients and oversee sustainability and improvements in patient journey. 

Essential functions: 

• Global business process owner across all clinical sites for the following entities of cell therapy supply chain 

• Leukapheresis 

• PBMC intermediate or frozen intermediate from leukapheresis 

• Investigational Medicinal Product (when needed) 

• Auxilary Medicinal Product (AxIMP) (when needed) 

• Accountability to deliver the business process by collaborating with multiple stakeholders: 

• Internal stakeholders: Clinical Sciences, Clinical Operations, Medical, GMP Operations, QA/QC, Biomarkers 

• External stakeholders: Clinical Sites, manufacturing and logistics vendors 

• Support the relationship building and management between hospital apheresis sites and Immatics clinical trials teams. 

• Accountability to align Immatics, clinical sites, and vendors to enable a seamless and short end-to-end patient flow: 

• Lead cross-functionally on planning, forecasting, prioritization and escalation of patient material through patient journey to enable a short end-to-end time 

• Activate and manage patient registration and study flow in software platform, when applicable. 

• Coordinate leukapheresis and manufacturing slot allocation, sample shipment and logistics. 

• Maintain accountability for chain of identity, custody and temperature deviations during shipments, support deviations and develop CAPAs. 

• Interface with clinical operations to forecast patient infusions and align drug product delivery at the clinical site. 

• Maintain accountability for adequate packaging inventory, customs documentation and current import licenses. 

• Manage third-party vendors, contract, budget, invoice, provide on call coverage for vendors critical to patient journey. 

• Manage clinical site shipping qualification and training on most current SOPs for leukapheresis and drug product shipments 

Secondary functions: 

• Support clinical operations, QA and CMC to enable new clinical site qualification and training for leukapheresis. 

• Assist QA with apheresis site audit scheduling and execution, communication and execution of Quality Assurance Agreements with clinical apheresis departments.