Scientific Director, US Medical Affairs, CAR T (Passaic,NJ)
Posted on Jun 10, 2019 by Celgene
Location: Offsite, New Jersey, United States
Job Category: Medical
Work Location: OFFSITE
Organization: Medical Affairs
Employee Status: Full-time
Job Type: Regular
The Director, CAR T Lymphoma/CLL, US Medical Affairs will report to the Senior/Executive Director, Lymphoma, USMA. He/she will be primarily field-based with additional participation with activities at the Summit Headquarters. This individual will provide clinical/scientific leadership and support for CAR T compounds in various stages of clinical development, as well as approved products. This individual s responsibilities will include strategic and tactical planning of medical affairs CAR T program site support and provide expertise to internal team on launch. Lead and support various Medical Affairs cross-functional working groups, as designated by Medical Disease Leads, with priority to activities related to CAR T site qualification, verification and post-launch CAR T site support. He/she will need to have the capability to travel and provide on-site support for designated CAR T sites as needed in collaboration with the medical field team ( MSL and Field Medical Directors). He/she will represent US Medical Affairs as needed, serving as a therapeutic area expert in CAR T products. This individual s priority focus will be supporting the strategic and tactical discussions related to JCAR017 (liso-cel) and assist with presentations with internal colleagues, as well as external experts and investigators.
Responsibilities will include, but are not limited to, the following:
Strategic and Tactical Planning with priority focus in JCAR017/liso-cel: Responsibility for the Medical Affairs aspects of the following plans, in alignment with global plans, and their timely updates:
o Brand plans
o Launch plans
o Publication plans
Assist and act as liaison to the field medical team during the CAR T program site qualification and verification process, as well as, ongoing post-launch CART site support to the field medical team. He/she will take responsibility to lead the development of documentation and tools for the assessment of medical criteria for CAR T program site certification and assist in the implementation of the operational components for the field medical team, including training in collaboration with the field medical experts and disease leads.
Provide support to the PAN- CAR T Medical and Safety Review Committee and assist with preparation for site assessments and provide support to the medical field team as the internal point of contact for site launch experience.
Interaction with key stakeholders as a therapeutic area medical strategy expert with priority focus in JCAR017/Liso-cel:
Strategic and tactical plan including supporting the planning and execution of ad boards and strategic steering committees.
This individual, under the leadership of Medical Affairs Disease Lead, represent US Medical Affairs as therapeutic area expert in CAR T in both internal and external venues including clinical sub-teams and advisory boards / steering committees. Represent Celgene at professional meetings, congresses, and local symposia.
Collaborate with Medical Affairs colleagues to define, guide and execute CAR T strategies and tactics with appropriate use of resources.
Provide high quality clinical input and review of the following but not limited to: CAR T strategy plans with priority focus in JCAR017/liso-cel and the medical affairs related CAR T site onboarding processes, abstracts, posters, slides, manuscripts, educational materials, steering committee and advisory board meeting objectives, Medical information letters, and Commercial Brand plans.
Medical Affairs partners in therapeutic area
CAR T Program Sites
Ad boards and steering committee
The ideal candidate will have the following mix of professional and personal characteristics:
MD, DO, APN, PharmD, PhD, preferable with clinical, research and/or industry experience in cellular therapy and Hematology/Oncology.
A minimum of 5-7 years academic/industry experience strongly preferred
Expertise in cellular therapy/hematopoietic stem cell transplantation and/or lymphoid diseases is a strong plus.
Excellent analytical skills and solid experience in translating medical/clinical information into medical affairs strategies.
Proficiency in critical data review and interpretation.
Matrix leadership of cross-functional teams.
Excellent oral and written communication skills, including presentations to large groups, facilitation of interactive discussions, and 1:1 discussions with thought leaders.
Demonstrated customer focus orientation and credibility with customers.
Knowledge/application of data sources, reports and tools for the creation of solid plans.
Regular travel will be required (approx. 65%).
COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
\"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.\"
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Associated topics: ancmg, hem onc, hematology, lah, oncology, palliative, physician md, physician md do, radiation, thedacare