101 days ago on jobs.celgene.com

Associate Director, Medical Affairs ImmunOncology EMEA

Celgene Switzerland SA

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Associate Director, Medical Affairs ImmunOncology EMEA

Associate Director, Medical Affairs ImmunOncology EMEA

Req #:16001358
Job Category:Medical
Work Location:Boudry, Switzerland Route de Perreux 1 Boudry 2017
Organization:Celgene R&D Sarl
Shift:Day Job
Employee Status:Regular
Job Type: Standard
Job Level: Manager
Travel:Yes, 50 % of the Time



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





Skills/Knowledge Required:

 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

 Detail-oriented, well-organized

 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