CAR T Medical Manager
- Tokyo, Japan
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
所属部門/部/課•室 (Department/Division) : Japan CAR T Medical, Japan Medical Affairs
業務報告先 (Reporting to) : Japan Head of Medical, CAR T
勤務地 (Location) : Marunouchi, Tokyo
概要 (High-level Description; including manage team/individuals or not)
Represent CAR T Medical function and maximize the patient benefit through Medical Plan development and implementation.
役割と責任範囲 (Roles & responsibilities)
1) Continuously identify Unmet Medical Needs (UMN) related to assigned Therapeutic Area and CAR T products based on the regular dialogue with Thought Leaders (TL), advisory board meetings, published information (domestic/overseas books/journals/congresses) and other available information.
2) Ensure that the local and global medical plans are consistent with UMN
Medical Plan and Expertise:
1) Under the oversight of CAR T Medical Director, develop Medical Plan by integrating UMN, data generation, publication, advisory boards, TL engagement, medical education, and any additional activities along with a given template and policy accompanied by a concrete budget plan. Update the Medical Plan at budget update cycle.
2) Clearly explain the Medical Plan and ensure alignment with multiple stakeholders in BMSKK as well as Global Medical.
3) Completely understand internal procedural documents (PD), other relevant rules, laws and regulations in Japan. Assure that Medical plans and its implementation comply with these rules/regulations/laws.
4) Lead medical matrix team for Medical Plan development and implementation. Appropriately align each activity with the Brand Team activity.
5) Provide adequate scientific support for internal stakeholders.
1) Identify data gap for the assigned CAR T product between the available data and ideal data set to satisfy the UMN, to promote appropriate use of the assigned CAR T product, and to maximize the patients' benefit.
2) Under the oversight of CAR T Medical Director, strategically and creatively develop a data generation plan to fill the data gap taking feasibility, scientific adequacy, and ethical considerations into account.
3) Explain, discuss and align the data generation plan with internal stakeholders (global medical, brand team, etc.)
4) Implement the data generation plan including ISR request handling (interface to investigators, representative of BMSKK toward global team).
5) Keep tracking the progress and update the data generation plan.
1) In collaboration with relevant internal functions, strategically develop a publication plan of the assigned Therapeutic Area and CAR T product including original papers and congress presentations focusing on company-sponsored clinical trials and get endorsed from the governance bodies.
2) Implement publications with targeted schedule. This includes story building, communication with external/internal authors and reviewers as well as medical writer, contents validation, and on-time delivery of the publication.
3) Update the publication plan according to the clinical trial progress, UMN and competitive landscape.
1) Collect TL insights by planning and conducting Advisory Boards to identify, confirm and fulfill UMN around assigned Therapeutic Areas and CAR T product, in a completely compliant manner with related procedural documents (PD).
1) Conduct scientific exchange and maintain relationship with TLs identified based on objective and transparent definition, in compliant with related PD.
2) Track and keep the record of TL interactions in compliant with related PD.
1) Identify the needs for medical education based on UMN to advance the therapy, science and appropriate understanding of the assigned CAR T product.
2) Plan on medical educational meetings/printed materials/other communications considering adequacy and feasibility, and implement them.
1) Perform qualification assessment of CAR T treating medical sites by verifying all items in the checklist.
2) Communicate with sites about the assessment results, support improvement plans, conduct follow-up verification as needed.
3) Provide key trainings to site staff with regard to CAR T product knowledge, product preparation and administration, AE management, documentation requirement, RMP activities etc. in accordance with the relevant manuals and materials.
Note: Roles & responsibilities described above may be shared among multiple CAR T Medical Managers to collectively fulfill the duty of CAR T Medial function.
必要な知識/スキル (Required knowledge/skills)
1) Knowledge of hematological malignancies (disease mechanism, epidemiology and typical treatment in Japan) at specialized physician's level.
2) Knowledge about Promotion Code and any other applicable regulations to Medical Affairs in Japan.
3) Preferably with knowledge of clinical research, clinical development (Ph1-4), ISRs, Japanese PMS.
4) Preferably with knowledge of CAR T clinical data in publications.
1) Skills to analyze data and information, identify needs/risks, translate them into actionable plan, and implement it with regular monitoring and issue management.
2) Communication, presentation and negotiation skills both internally and externally.
3) Team management skills to lead a team, nurture trust and confidence among members, and identify and address issues in a team.
4) Operationally efficient and able to liaise with stakeholders from all levels both internally and externally
5) Entrepreneurship and flexibility to innovate for medical value in new treatment CAR T modality
1) Solid experience in Medical Affairs in Japanese industry
2) At least three-year experience of medical, pharmaceutical or life-science field
3) At least two years of experience in the area of hematological malignancies
4) Preferably with solid field experience and interaction with TLs in allogeneic transplantation and/or cellular therapies (CAR T) management
1) MD, Veterinarian Doctor or PhD in medical/pharmaceutical/veterinarian/life-science area
2) First author for at least an original paper (PubMed-cited level) and a congress presentation
1) Complete level of written Japanese - can completely understand medical articles and general business documents in Japanese, can write formal Japanese at business setting, and can write a medical article in the assigned area.
2) Complete level of oral Japanese - can make presentations, have medical discussions and build an appropriate relationship with HCPs.
3) Advanced level of written English - can completely understand medical articles of assigned area and general business documents in English
4) Advanced level of oral English - can make presentations, have discussions and negotiations with global counterparts in English
5) TOEIC最低保持スコア (TOEIC minimum requirement score) 780
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