Johnson & Johnson Careers

Director, CAR-T & Apheresis Site Liaison (CASL)

Spring House, Pennsylvania
Clinical Trial Administration


Job Description

Requisition ID: 4433180617

Janssen Research & Development, LLC, a member of Johnson & Johnson Family of Companies, is recruiting for a Director, CAR-T & Apheresis Site Liaison (CASL). The preferred location is Springhouse, PA but open to other US based sites. Up to 50% 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, CAR-T & Apheresis Site Liaison (CASL) will serve as a cross-functional, customer-focused single point of contact to manage the highly complex and novel logistics networks for CAR-T assets, and will provide detailed support to clinical sites participating in clinical trials or administering approved chimeric antigen receptor (CAR)-T cell products. The CASL will work with the Janssen Global Clinical Development Organization (GCDO) and Oncology Therapeutic area to provide scientific and medical input into CAR-T projects and develop a team of CAFS junior staff as the number of CAR-T assets in development increase..

As applicable, is responsible for the line management and development of supporting staff, which may include Performance and Development Management, talent management and training requirements.

The Director, CASL has the overall responsibility for all aspects of the vein to vein process for the development of CAR-T cells. The CASL will be involved in selection, approval, and initiation of hospitals/sites that will collect and process human cells, tissues, and cellular and tissue-based products (HCT/Ps); including site evaluation, contracting, training, implementation of Janssen requirements, and oversight of processes related to HCT/Ps collections and processing.

RESPONSIBILITIES:

• Coordinate and support clinical sites with all aspects of the vein-to-vein process for the development of CAR-T cells.
• Demonstrate the patient allocation / manufacturing sign-up process.
Provide on-site support to answer questions and ensure appropriate support from subject matter expert.
• Develop a clinical 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.
• Develop subject matter expertise management of adverse events in clinical trials of CAR-T cells.
• Drive continuous improvement in the patient journey in CAR-T clinical trials
• Support clinical site qualification and training for apheresis material processing.


• Identify, select and manage critical logistics partners
• Design and implement checkpoints to ensure low manufacturing failure rates and successful monitoring of Chain of Custody (CoC) and Chain of Identity (CoI)
• Facilitate customized hospital ordering and logistics, processes in an effort to ensure consistent successful documentation of CoC and CoI.
Coordinate internally for site quality assessments, audits, inspections, and perform operations performance reviews (i.e. collecting data on trends and driving continuous improvement).

• Acquire and sustain advanced knowledge of CAR-T with respect to GTP, GMP, GCP and the clinical trial setting
• Become a key point of contact for technical questions from internal Janssen teams and clinical sites
• Management of change control, deviations, investigations, and CAPA.
• Ensure Janssen management is kept informed of all critical and major issues.
• Ensure coordinated contact and collaboration is maintained with other functions (e.g. Quality Assurance, Compliance Clinical, Sourcing, Legal, Supply Chain, Regulatory, Manufacturing Operations).
• Maintain current knowledge of regulatory requirements for HCT/Ps.


Qualifications
• (MS, PhD., Pharm. D., MD, RN) in a scientific discipline, or A Bachelor’s degree, with equivalent work experience, is required.
• 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.
• Proficiency in Microsoft Word, Excel, PowerPoint; Microsoft project is required.


Primary Location
United States-Pennsylvania-Spring House
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Clinical Trial Administration
Requisition ID
4433180617