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Associate Director, Medical Affairs ImmunOncology EMEA
The AD/D will work with the Senor Director Medical Affairs, Scientific Adviser EMEA and serve as the lead and functional customer focused single point of contact to provide detailed support to all centres not currently participating in Celgene studies but using or potentially intending to use chimeric antigen receptor (CAR) T cell products in the EMEA region . The AD/D will work with the GCRD and Global Trial Management/Monitoring (GTMM) teams as well as CRD, Market Access and Commercial Teams to provide scientific and medical input into CAR T projects. This includes understanding of the patient flow, reimbursement, centre capabilities, potential homebrew solutions, educational and scientific support needs
• The AD/D will be a product and TA subject matter expert to support internal and external customers. Extensive travel to EMEA sites interested in CAR T programs and not currently participating in Celgene clinical studies but requesting Celgene’s input is mandatory and essential.
Responsibilities will include, but are not limited to, the following:
1. Understand patientflow, capabilities and needs of a selected number of key sites.
2. Recommend sites for future studies.
3. Develop subject matter expertise in CAR T cell therapy and management of adverse events and clinical trials of CAR T cells.
4. Support site activation
5. Develop internal and external training materials
6. Provide internal and external guidance and training on implementation of CAR T cell therapies
7. Support with site qualification and training for Aphaeresis procedure for sites intending to use commercial product
8. Develop working knowledge of ATMPs and related regional/local regulations and work with Market access and affiliate personal to understand centre reimbursement and potential hurdles
9. Support the development of a site specific CAR-T network, ensuring multi-disciplinary participation and coordination of patient management when requested by the site in anticipation of Celgene CAR usage. This will include but is not limited to :
o Training of all key stakeholders at treatment site (e.g., pharmacy, physicians, nursing staff and ICU)
o Facilitate customized hospital ordering and logistics, processes in an effort to ensure consistent cell logistics outcomes
o Coordinate mock shipment with Cell Lab (as needed)
o Demonstrate the patient allocation / manufacturing sign-up process
o Ensure product tracking and timely access to appropriate Celgene resources
o Provide on-site support to answer questions and ensure appropriate support from subject matter experts
o Support appropriate education of referring physicians (e.g., appropriate patients, apheresis timing)
o Ensure ready access to rescue medicines (e.g., anti-cytokine therapies) are available
• Post approval, regularly share treatment site experience and challenges with appropriate Celgene functions and develop custom solutions as needed
• Lead the compliant approval and on-boarding of new CAR T centres treatment not having participated in Celgene CART studies:
o Conduct site capabilities, perform process assessment and confirm site certification
o Facilitate training of apheresis staff to perform apheresis and provide quality starting manufacturing material
o Support ordering, logistics, and communication processes as needed
o Ensure consistent, timely delivery of CART products
o Connect treatment site with appropriate Celgene subject matter experts to address “just-in-time” needs
o Actively participate in regular scheduling/logistics meetings to review cell status, logistics, etc.
• Support Medical affair studies , IIT’s and post approval requirement studies for patients enrolled on non CRD Celgene CART use
Undergraduate degree in life sciences required. Advanced degree in the life sciences (e.g. Phd PharmD, NP, PA, RN) or Medical degree preferred.
Prior experience in Medical Affairs with proven KOL interaction, evidence generation and communication skills preferred
Working knowledge and experience in the treatment of hematologic malignancies including acute leukemias, non-Hodgkins lymphoma, and multiple myeloma
Allogeneic stem cell transplant or apheresis experience preferred
Medical/scientific and clinical research knowledge
Ability to rapidly solve problems and deal with organizational complexity
Knowledge of Medical Terminology
Knowledge of clinical trial design, basic statistics, pharmacodynamics and pharmacokinetics
Knowledge of GCP and ICH Guidelines
EMEA Travel required
Proficient in Microsoft Word, Excel, PowerPoint; Microsoft project and JReview a plus
Demonstrated ability to work as part of a team
Ability to interface cross-functionally with clinical personnel.
High level of interpersonal and communication skills (written and verbal)
Prior experience as a medical monitor, clinical science or medical liaison, health care provider valuable
Interest in working with medical affairs and commercial teams
Demonstrated ability to network and build partnerships with important external customers
Strong leadership skills with a clear service orientation
Ability to assimilate technical and scientific information quickly