シニアアソシエイトメディカルリード 免疫領域担当/Medical lead， Immunology / 外資製薬メーカー
|職種||シニアアソシエイトメディカルリード 免疫領域担当/Medical lead， Immunology|
Represent Medical Strategy function of the assigned product and maximize the product value and patient benefit through Medical Plan development and implementation.
・Proactively and continuously identify Unmet Medical Needs (UMN) related to assigned products based on the regular dialogue with Thought Leaders (TL)， advisory board meetings， published information (domestic/overseas books/journals/congresses) and other available information (statistics， epidemiology etc).
・Proactively communicate UMN to global team and make sure that the global medical plan is consistent with UMN in Japan.
・Identify data gap for the assigned product between the available data and ideal data set to satisfy the UMN， to promote appropriate use of the assigned product， and to maximize the patients’ benefit.
・Strategically and creatively develop a data generation plan from scratch to fill the data gap taking feasibility， scientific adequacy， and ethical considerations into account. This can include post-marketing trials (PMT)， request for proposal (RFP) of investigator-sponsored researches (ISRs)， and corporate-sponsored researches (CSRs).
・Explain， discuss and align the data generation plan with internal stakeholders (Brand team， Executive Management， Global Medical etc).
・Implement the data generation plan including ISR request handling (interface to investigators， representative of BMKK toward global team).
・Keep tracking the progress and update the data generation plan at Medical Plan cycle and/or budget update/revision cycle.
・Strategically develop a publication plan of the assigned product including original papers and congress presentations focusing on company-sponsored clinical trials (Ph.1~Ph.3， Ph.4 if applicable) and get endorsement from J-EDT/J-FDT/Global Medical.
・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.
・Update the publication plan according to the clinical trial progress， UMN and competitive landscape and get endorsement.
・Support identifying TLs according to objective and transparent definition. Maintain and update the TL list at least annually.
・Track interactions and maintain relationship with TLs in a completely compliant manner with related procedural document
|求める経験||Knowledge of assigned therapeutic area (disease mechanism， epidemiology and typical treatment in Japan) at specialized physician’s level.
・Knowledge of the assigned product covering CTD Module 2.4 ~ 2.7 and 5.3.5 as well as all publications including the latest one.
・Basic knowledge about clinical development (Ph1-4)， ISRs， Japanese PMS and matrix organization in BMKK.
・Knowledge about Medical Affairs Law， Fair Competition Code (FCC)， Promotion Code， and any other applicable regulations in Japan.
・Skills to analyze information (TL interactions， surveys， public information)， identify needs/risks， translate them into an integrated medical plan， and implement it with regular monitoring and issue management.
・Communication skills as a professional in Japanese context， both internally and externally.
・Team management skills to lead a team， nurture trust and confidence among members， and identify and address issues in a team.
・One year or more experiences in Medical Affairs in Japanese industry.
・Three years or more experiences of research in medical， pharmaceutical or life-science field.
・Two years or more experiences in assigned therapeutic area
・MD， Veterinarian Doctor or PhD in medical/pharmaceutical/veterinarian/life-science area
・First author for at least an original paper (PubMed-cited level) and a congress presentation
・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.
・Complete level of oral Japanese ・ can have medical discussions and build an appropriate relationship with HCPs
・Advanced level of written English ・ can completely understand medical articles of assigned area and general business documents in English
・Advanced level of oral English ・ can discuss， negotiate and persuade in English， can represent BMKK Medical Strategy in a global meeting.
|年収||1000万円 - 1200万円|