Cell Therapy Clinical Specialist

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Summary

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

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

Problem-solving skills

Excellent interpersonal and communication skills (written and verbal)

Demonstrated ability to network and build partnerships with important external customers

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com