autolus hiring Manager, Cellular Therapy and Logistics Specialist

Job vacancy: Manager, Cellular Therapy and Logistics Specialist

Autolus are hiring! 
About Autolus
 
Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer, using a broad suite of proprietary and modular T cell programming technologies. The company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognise cancer cells, break down their defence mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of haematological malignancies and solid tumours.
 
Job Title Manager, Cellular Therapy and Logistics Specialist
Grade 6 /7
Reports to Director, Patient & Cell Management
Department Clinical Operations
Hours Full time
Location US – office or home based
 
Role Summary
 
The Manager, Cellular Therapy and Logistics Specialist will be responsible for the coordination and scheduling of patients and their cells (apheresis & final drug product), through the clinical/treatment site. This position requires close collaboration between the Investigator Site, Couriers and internal functions in Autolus including Manufacturing, Supply Chain, Clinical Operations and Medical to ensure that each patient visit and their CAR T-cells are coordinated seamlessly and effectively through their cell journey. This position requires the post holder to be responsive to meet the required timelines and the needs of the patient, clinical trial and manufacturing in a rapidly changing environment.
 
The Manager, Cellular Therapy and Logistics Specialist will function as part of the Patient & Cell Management team within Clinical Operations, leading our efforts to seamlessly and effectively manage the patient visits and drug product for all Autolus clinical trials.  
 
The Manager, Cellular Therapy and Logistics Specialist will collaborate with the Patient & Cell Management team and partner with key internal and external stakeholders to improve and implement a robust operational framework for patient scheduling to support the expansion and delivery of all Autolus cell therapy clinical trial studies in the EU and US.
 
 
The Manager, Cellular Therapy and Logistics Specialist will also work with the Patient & Cell Management team on the build-out and line management of the global patient scheduling team.
 
Key Responsibilities
 
  • To act as the regional interface between clinical trial sites, clinical study team, manufacturing and clinical operations to ensure smooth scheduling and coordination of both patients and cells within and across EU/US clinical trial sites.
  • To build and maintain positive and collaborative relationships with key partners in Clinical Operations, Clinical Development, Manufacturing, and Supply Chain 
  • Lead patient scheduling and cell management tasks through from:
    • confirming apheresis and subsequent despatch to manufacturing
    • coordinating Courier pick-ups and deliveries as well as preparation of shipping documentation
    • communicating product manufacturing milestones to Clinical Sites & coordinating patient visits preparation prior to infusion (chemotherapy conditioning)
    • CAR T-cell Drug Order form to clinical trial site & confirming receipt by clinical site
    • review documents prior to site shipments
    • coordinating of the final drug product (CAR t-cell) to the investigator site and successful product infusion to the patient
  • Maintain the patient confidentiality and adhere to all relevant Data Protection requirements.
  • Use relevant tools and communication with clinical sites, optimise patient and drug scheduling, to optimize the number of patients recruited per site per month/year.
  • Coordinate all aspects of patient cell procurement and their “cell journey”, including apheresis, shipping to, manufacturing and successful return of CAR T-cell product back to the clinical trial sites.
  • Communicate study requirements to the clinical sites, while ensuring adherence to the cell journey process.
  • Continuously refine and improve the cell journey process including the screening/enrolment of trial patients, patient scheduling and treatment process.
  • Prepare metrics and updates for management as assigned. Proactively identify potential study issues/risks and recommend/implement solutions.
  • Work with multiple internal and external stakeholders, including vendors, to communicate detailed timelines and ensures performance expectations are met.
  • Act as a functional expert for the “Cell Management Portal”.
  • Responsible for the implementation/deployment of Autolus Cell/Drug Handling manual at the investigator site, including oversight of completed up-to-date training of relevant personnel. 
  • Ensure compliance to GxP including ICH GCP guidelines and regulations across the Investigator sites and ensures Autolus ‘Inspection Readiness’ at all times.
  • Participate in the development, review and implementation of departmental SOPs and processes.
  • Assist in Autolus product recall procedures.
  • Manage dummy runs ‘to and from’ sites to ensure all systems are operating to the required standards
Demonstrated skills and competencies
 
E – Essential
P – Preferred

Experience
  • Significant relevant clinical/healthcare logistics or customer service experience (E).
 
Qualifications
  • Bachelor’s degree in nursing, natural sciences, supply chain or related field; or equivalent experience (E).
Skills/Specialist knowledge
  • Previous experience in the set up and delivery of patient scheduling activities in support of cell therapy clinical trials on an international level (E)
  • Has experience in areas such as: Apheresis and Cell Therapy Medical Centres, Bone Marrow Transplantation, Clinical Research, Medical Liaison, (P)
  • Has experience of using complex IT systems or IT portals in the fields of supply chain management, customer service and procurement (P).
  • Has working knowledge of biologic material transport (P).
  • Ability to establish priorities, work independently, and proceed with objectives without supervision.
  • Is expert in understanding of current ICH GCP guidelines (E).
  • Has worked in a role involving precise verbal and written communication, related to therapies, devices, medicines, patient care or safety (E).
  • Strong analytical, problem solving and decision-making skills (E).
  • Outstanding organizational skills with the ability to multi-task and prioritize (E).
  • Strong attention to detail and rigorous data accuracy (E).
  • Is diligent, reliable and willing to ask for help from others (E).
  • Ability to successfully influence and collaborate across multiple teams and functions (E).
  • Demonstrates initiative and willingness to work hands-on and with a sense of urgency, in a fast-paced rapidly changing environment (E).
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities (E).
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description (E).
Qualified applicants should send their CV to hr@autolus.com or B.Nash@autolus.com