Senior Clinical Specialist, CAR-T (Field-Based) San Francisco United States,
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
***This is a field-based position.***
The Sr. CS will serve as a single-point-of-contact for product & process related questions at CAR T treatment sites in an effort to ensure process consistency and compliance from study start up onwards. An ability to identify, prevent, and solve logistical issues that would delay or prevent study site activation and individual subject treatment is critical. The CS becomes a product, protocol and project subject matter expert to support internal and external customers. Travel to investigational sites for CAR T programs is mandatory and essential.
Responsibilities will include, but are not limited to, the following:
- Coordinate site interactions for CAR T cells clinical trials with: GCRD, GTMM, CMC/T-Cell Operations, Regulatory, Medical Affairs, and Commercial teams.
- Prevention of, and response 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 Aphaeresis procedure
- Develop working knowledge of ATMPs and related regulations
- Develop a site specific CAR-T network, ensuring multi-disciplinary participation and coordination of patient management
The Sr. CS will serve as a “bridge” for the treatment sites to ensure process consistency and support from clinical development phase through post-approval commercialization phase.
- Work with CRAs, GTMM and clinical trial sites to coordinate on-boarding activities:
- 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
- Provide on-site support and education to answer questions and ensure appropriate support from subject matter experts
- Regularly share treatment site experience and challenges with appropriate Celgene functions and develop custom solutions as needed
- Facilitate the compliant approval and on-boarding of new CAR T treatment centers:
- Conduct site capabilities, perform process assessment and confirm site certification
- Facilitate training of apheresis staff to perform apheresis and provide quality starting manufacturing material
- Train and interact with Celgene Medical Affairs and Commercial teams to shape future commercialization plans
- Support long term follow-up studies for patients enrolled on clinical trials of CAR T cells and commercial use
*LI-EXCelgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
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