• Leads the development of a cross-functionally integrated disease medical strategy and plans that optimize patient benefit and access that is complementary to launch preparation and life cycle management plans for the assigned programs embedded in IDAPS, country strategy, and operational plans. • Responsible for efficiently plan and manage budget related to the programs • Leads strategic discussion and gains alignment with global medical affairs through regular involvement and contribution to IDMT • Responsible for supporting medical training, education, and commercial activities in alignment with the disease franchise and compliant with applicable guidelines. Supported or led events include educational events (e.g. stand-alone meeting, scientific symposia), scientific congress, disease awareness trainings, speaker events, advisory boards, etc. • Responsible and accountable for review and approval of key scientific communications, medical information documents, and commercial documents within P3 compliance frame work • Provides medical input or medical oversight on other activities such as publication strategy, global and local MA clinical trials, investigator-sponsored trials, grants review, etc. • Responsible for creation of MSL scientific exchange strategy and insight analysis • Provides medical leadership in developing and executing external stakeholders plan General Responsibility for Safety management • Training of HCP’s, treating physicians, nurses, site staff on product safety profile and handling Adverse events • Internal training on product safety (e.g. PVO-Pharmaco Vigilance, MSL & Account Managers) • Certify site staff and internal associates on product safety compliance • Ongoing product safety handling training & information sharing • Specific CTL019 efficacy & safety communication • Involvement in determination of eligibility of patients • Focus mainly on treatment site • • • High importance of safety handling and management • Awareness of safety management topics & processes o Treatment & referral sites o NVS internal • Education of hematological society
Medical Doctor : -Ideally Oncologist/hematologist , preferably with SCT (Stem Cell Transplant) experience -at minimum clinical experience in Oncology/hematology or Internal medicine/ critical care. Fluent oral and written Japanese and English. • ≥ 5 years of involvement in GCP clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. • Strong management, interpersonal, communication, and problem solving skills. • Strong negotiation and diplomatic skills, experience with health authorities desirable. • Medical/scientific and operational expertise in oncology and/or hematology.