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Cell Therapy Clinical Specialist, Summit, New Jersey

Created10/08/2020
ReferenceR1530367
CategoryClinical Dev
Job typeFull-Time
CountryUnited States
StateNew Jersey
CitySummit
Zip07901
SalaryCompetitive

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

POSITION

CAR T Cell Therapy Clinical Specialist

PRE-REQUISITES

Degree in Life Sciences (e.g. biology or related science field; nursing, pharmacy or related medical field), minimum 3 years of experience in clinical research development or equivalent

LOCATION

Global Placement Options (US, EU, Japan)

Summary/Scope:

The CAR T Cell Therapy Clinical Specialist (CTCS) will serve as a cross functional customer focused contact to provide detailed support to investigational treatment site teams participating in clinical trials or administering chimeric antigen receptor (CAR) T cell products. The CTCS will work with the GCRD and Global Trial Management/Monitoring (GTMM) teams as well as Patient Operations (CTDO), Medical Affairs and Commercial Teams to provide scientific input into CAR T projects.

The CTCS will serve as the primary contact for product & process related questions at CAR T treatment sites to ensure process consistency and compliance. The role of the CTCS is to identify, prevent, and solve logistical issues that relate to CAR T therapy and/or would delay or prevent patient enrollment and treatment. The CTCS is a CAR T product subject matter expert to support internal and external customers. Regular travel to global investigational sites for CAR T programs is essential.

Responsibilities will include, but are not limited to, the following:
  • Develop and update internal and external training materials including the Product Handling Manual (PHM)
  • Provide internal and external training to appropriate personnel (e.g. pharmacy, physicians, nursing staff and ICU) on delivering CAR T cell therapies within clinical trials (e.g. Pre-Site Initiation Visits, Site Initiation Visits, Investigator Meetings, Infusion and follow-up visits, etc.)
  • Provide support regarding the Site Readiness and Onboarding Plan
    • Collaborate with CRSs, CRAs, GTMM and clinical trial sites to coordinate on-boarding activities
    • Responsible to ensure site level key milestones are met on time and with high quality
  • Serve as support for potential issues that arise during enrollment and conduct of CAR T clinical trials.
  • Develop subject matter expertise in CAR T cell therapies
  • Relationship management with sites conducting clinical trials with CAR T therapies
  • Regular follow-up with site personnel (e.g. study coordinators/nursing staff) post CAR T cell infusions
  • Facilitate the completion of CAR T product site storage documentation and liase with Quality Assurance as appropriate
  • Participate in continued process improvement of CAR T cell therapy studies (e.g. subject forms, labels, product storage, product manuals, etc.)
  • Serve as a resource for the treatment sites to ensure process consistency across the life-cycle of the CAR T products.
  • Communicate lessons learned and proactively contribute to developing custom solutions as needed
  • Regularly attend and actively participate in study team and other clinical meetings
  • Provide timely updates to manager
  • Set priorities with moderate guidance from manager
  • Identify problems/issues and contribute to implementing resolutions
  • Share best practices
  • Contribute to the onboarding of new or junior team members
  • Travel required (up to 70%)


Skills/Knowledge Required :
  • Undergraduate degree in life sciences required
  • A minimum of 3 years of experience in clinical research and development or equivalent
  • Prior pharmaceutical industry experience which includes direct communication with Investigators and site personnel preferred (e.g. clinical research scientist, clinical research associate, clinical nurse consultant, medical science liaison, etc.)
  • Ability to assimilate technical and scientific information quickly
  • Working knowledge of Oncology (i.e. including leukemia, lymphoma, and multiple myeloma, etc.)
  • Allogeneic stem cell transplant and/or apheresis knowledge preferred


Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
EmployerBristol-Myers Squibb

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