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.
Summary / Scope :
The Clinical Specialist (CS) 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 in the EU.
The CS will work with the GCRD and Global Trial Management / Monitoring (GTMM) teams as well as Medical Affairs and Commercial Teams 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.
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. Extensive travel to EU investigational sites for CAR T programs is mandatory and essential.
Responsibilities will include, but are not limited to, the following :
Coordinate site and country level interactions for clinical trials with CAR T cells with GCRD, GTMM, CROs, Translational Development, 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 regional / local regulations Develop a site specific CAR-
T network, ensuring multi-disciplinary participation and coordination of patient management
The 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.
g., pharmacy, physicians, nursing staff and ICU)Facilitate customized hospital ordering and logistics, processes in an effort to ensure consistent cell logistics outcomesCoordinate mock shipment with Cell Lab (as needed)Demonstrate the patient allocation / manufacturing sign-
up processEnsure product tracking and timely access to appropriate Celgene resourcesProvide on-site support to answer questions and ensure appropriate support from subject matter expertsSupport appropriate education of referring physicians (e.
g., appropriate patients, apheresis timing)Ensure ready access to rescue medicines (e.g., anti-cytokine therapies) are available
in-time needsActively participate in regular scheduling / logistics meetings to review cell status, logistics, etc.
Skills / Knowledge Required :