Offsite, New Jersey, United StatesJob Category:
Medical AffairsEmployee Status:
The Field Medical Director, CAR T Lymphoma/CLL/MM US medical affairs, will be instrumental in supporting the execution and implementation of CAR T site medical strategy. He/she will be located at the Seattle (or Summit) headquarters and will have field-focused responsibilities (75%). This individual will represent US Medical Affairs as therapeutic area expert (PAN-CAR T) and provide clinical/scientific leadership and support for CAR T compounds in various stages of clinical development, as well as, approved products.
He/she will take responsibility to lead the development of documentation and tools for the assessment of medical criteria for CAR T program site onboarding process through to certification and assist in the implementation of the operational components for the field medical team, including training in collaboration with the scientific directors and disease leads. This individual s responsibilities will include strategic and tactical planning of medical affairs CAR T program site support and the point of contact for internal site launch experience. 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. He/she will represent US Medical Affairs as needed, serving as a therapeutic area expert in PAN-CAR T products.
Responsibilities will include, but are not limited to, the following:
The ideal candidate will have the following mix of professional and personal characteristics:
- Primary medical director point of contact for field medical team (MSL) and CAR T sites within designated region.
- Ensure positive first CAR T clinical experience for each product at individual sites.
- Ensure sites continue to meet certification criteria after initial certification.
- Point of contact for escalated calls from HCPs treating patients with Celgene CAR T products that come thru the 24hr/7day call center or medical unsolicited requests.
- Assist the field medical team (MSL) and cross-functional partners during CAR T program site qualification and certification process.
- In collaboration with the MSL national director, ensure all CAR T sites have medical support.
- Assist and lead post-launch CART site support and strategy in collaboration with the field medical team (MSL).
- Point of contact for clinical issues related to non-conforming products and assist with strategies related to non-conforming products ( including protocols).
- Collaborate in the development of training materials for sites and medical field team and provide training for both external and internal stakeholders including REMS.
- Lead and support various Medical Affairs cross-functional working groups with priority to activities related to CAR T site qualification, verification and post-launch CAR T site support.
- Responsible for refining strategies and identify best practices for optimal medical support for CAR T programs.
- Understand and develop site points of pain problem lists with clinical relevance.
- Develop tools to assist sites in ease and quality of care to patients.
- Work with EMR support/clinical pathways.
- In collaboration with the disease leads, drive the strategy and execution of train-the-trainer project.
- Collaborate with Medical Affairs launch leads to define, guide and execute CAR T strategies and tactics with appropriate use of resources.
- Support CAR T medical affairs studies (e.g. registries, protocols).
- Provide therapy area medical and scientific expertise to clinical study teams and key stakeholders.
- Represent the US Medical Affairs as a therapeutic expert at ad boards and steering committee.
- Represent Celgene at professional meetings, congresses, and local symposia.
- In collaboration with field medical team (MSL), lead and execute on external KOL engagement plan.
- Cultivate and nurture strong collaborations, relationships and support with Investigators, Academic partners and KOL s.
- Provide high quality clinical input and review of the following but not limited to: CAR T strategy plans, abstracts, posters, slides, manuscripts, educational materials, steering committee and advisory board meeting objectives, Medical information letters, and Commercial Brand plans.
About UsCOMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
- MD, 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 hematological malignancies is a strong plus.
- Demonstrate clinical management knowledge and skills.
- Excellent analytical skills and solid experience in translating medical/clinical information into medical affairs strategies.
- Proficiency in critical data review and interpretation.
- 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. 75%).
- Demonstrated ability to work as part of a team and problem solving skills.
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: administrative, administrative coordinator, administrative officer, administrative staff, administrative support, asso, beverage, operation, operational assistant, operations director