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Director, Apheresis Field Support
Spring House, Pennsylvania
Clinical Trial Administration
Requisition ID: 4684180228
Janssen Research & Development, LLC, a member of Johnson & Johnson Family of Companies, is recruiting for a Director, Apheresis Field Support. The preferred location is Springhouse, PA but open to other US based sites. Up to 70% domestic travel is required for this position.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
The Director, Apheresis Field Support will serve as a cross functional customer focused single point of contact to provide detailed support to investigational treatment site teams participating in clinical trials or administering chimeric antigen receptor (CAR) T cell products. The FTS will work with the Janssen Global clinical development organization (GCDO) and Oncology Therapeutic area to provide scientific and medical input into CAR T projects. This includes training and education as well as problem solving in the conduct and operations of clinical trials. The position is accountable for developing and meeting all the SOP and regulatory requirements.
As applicable, is responsible for the line management and development of FTS junior staff supporting the development of Human Resources programs which may include Performance and Development Management, talent management and training requirements.
The Director, Apheresis Field Support has the overall responsibility for ensuring high quality consistent supply of human cells & tissues (HCT) intended for use as manufacturing input starting materials in GMP cell processing / manufacturing of cell therapy products. The FTS will be involved in selection, approval, and initiation of hospitals/sites that will collect and process HCT; including site evaluation, contracting, training, implementation of Janssen requirements, and oversight of processes related to HCT collections and processing.
• Coordinate and support sites with all aspects of the vein to vein process for the development of CAR T cells.
• Prevent and respond to issues during enrollment and conduct of clinical trials.
• Develop subject matter expertise in CAR T cell therapy and management of adverse events and clinical trials of CAR T cells.
• Accelerate site activation and recruitment.
• Develop internal and external training materials Provide internal and external guidance and training on implementation of CAR T cell therapies.
• Support with site qualification and training for Leukappheresis procedure.
• Develop working knowledge of ATMPs and related regional/local regulations.
• Develop a site-specific CAR-T network (pharmacists, treating physicians, clinical trials coordinators, apheresis units, cell therapy units, outpatient treatment centers etc.), ensuring multi-disciplinary participation and coordination of patient management.
• Lead onboarding of sites, with accountability as the primary technical operations point of contact, ensuring ongoing operations are according to Janssen requirements.
• Training of all key stakeholders at treatment site (e.g., pharmacy, physicians, nursing staff and ICU)
• Facilitate customized hospital ordering and logistics, processes in an effort to ensure consistent cell logistics outcomes.
• Coordinate mock shipment with Cell Lab (as needed).
• Demonstrate the patient allocation / manufacturing sign-up process.
• Ensure product tracking and timely access to appropriate Janssen resources.
• Provide on-site support to answer questions and ensure appropriate support from subject matter expert.
• Ensure ready access to rescue medicines (e.g., anti-cytokine therapies) are available.
• Maintain clear technical/operational requirements (i.e. specifications, manuals, SOPs).
• Coordinate internally for site quality assessments, audits, inspections, and perform operations performance reviews (i.e. collecting data on trends and driving continuous improvement).
• Key point of contact externally for all technical questions on apheresis and cryopreservation.
• Management of change control, deviations, investigations, and CAPA.
• Support implementation and maintenance of local SOPs.
• Ensure management is kept informed of all critical and major issues.
• Ensure coordinated contact and collaboration is maintained with other functions (e.g. QA, Clinical, Sourcing, Legal, Supply Chain, Regulatory, Manufacturing Operations).
• Coordinate with other field personnel on ongoing site needs.
• Maintain current knowledge of regulatory requirements for HCT.
• Maintain knowledge of latest collection and preservation techniques.
• Have key input into resolving issues and issue escalation decision making for assigned programs/projects.
• Ensure that the operational objectives in projects assigned are met in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies, knowledge of GCP and ICH Guidelines.
• Acquire and sustain advanced knowledge of the therapeutic area and product and clinical trial setting in the TA
• An Advanced degree (MS, PhD., Pharm. D., MD, RN) in a scientific discipline is strongly preferred.
• A minimum of 7 years pharmaceutical experience and experience in GTP is required.
• Working knowledge and experience in the treatment of hematologic malignancies including acute leukemias, non-Hodgkins lymphoma and multiple myeloma is preferred
• Allogeneic stem cell transplant or apheresis experience and/or working with US or international blood/tissue requirements is preferred.
• Clinical Project Management skills and the ability to interface cross-functionally with clinical personnel is required.
• Understanding of drug development and submission requirements is required.
• Manufacturing and logistics understanding/experience is preferred.
• Ability to work independently and in a matrixed team environment is required.
• Ability to make decisions independently, innovative and strategic thinker with broad vision is required.
• Flexibility to adapt to changing situations, ability to prioritize tasks according to objectives, and provide problem resolution is required.
• Strong quality mindset is required.
• Effective leadership skills and proven ability to foster team productivity and cohesiveness is required.
• Proficient in Microsoft Word, Excel, PowerPoint; Microsoft project is required.
United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)
Clinical Trial Administration