ジャパンオンコロジーサイエンスユニット サイエンティフィックアフェアーズ アソシエイトプリンシパルサイエンティスト クリニカルサーチ



Associate Principal Scientist Clinical Research,Oncology Scientific Affairs(OSA),Oncology Science Unit(OSU),Japan Development(JD)

OSA Strategy and Roles/Responsibilities
1.Scientific Leader(SL)Engagement:
A)Proactively deliver non-promotional and unbiased scientific information to SLs by leveraging corporate R&D and company resources.
B)Conduct competitive scientific/medical and industry competitive intelligence(CI)and provide insights to the corporate R&D and the company.
C)Develop,update and implement strategically oriented site/SL engagement plan in collaboration with global and local R&D functions.
D)Develop,update and maintain SL list by utilizing a relevant system.
E)Proactively engage internal stakeholders to enable SLE in productive manners.
F)Explore scientific collaboration opportunities with academia in collaboration with corporate R&D functions.

2.Evidence Generation:
A)Identify investigator initiated study(IIS)
opportunities in oncology pre-clinical,clinical and translation areas,and lead/facilitate required processes including but not limited to pre-review,review,communication of corporate R&D and company decisions,contracting with investigators and follow up in collaboration with corporate R&D and company functions.
B)Lead,facilitate and support LDG by collaborating with corporate R&D and company functions.

3.Publication Support and Management:
A)Manage the development,tracking and update of Publication Plan
B)Support/Coordinate globally lead congress presentation and publication according to the Publication Plan in collaboration with corporate R&D and company functions.
C)Manage locally lead congress presentation and publication according to the Publication Plan in collaboration with corporate R&D and company functions.

4.Congress Support:
A)Plan and organize on-site scientific/medical CI.
B)Manage OSU post-congress reporting process in OSU.
C)Manage and coordinate on-site SL
engagement in accordance with the OSA SL engagement strategy and plan by collaborating with corporate R&D and company functions.

5.Medical Event and Advisory Meeting:
A)Plan and implement Japan local scientific advisory meeting named Japan Scientific advisory meeting named Japan Scientific Advisory Meeting(J-SAM)in collaboration with corporate R&D and company functions.
B)For matters relevant to Japan local(and Asia)clinical development and New Drug Application(JNDA),plan and implement locally organized advisory meeting in collaboration with corporate R&D and company functions.
C)In alignment with the corporate and local R&D strategies and objectives,plan and implement medical event by collaborating with internal and external stakeholder.

6.Medical Expertise(apply only to a licensed physician in Japan):
A)Medical Consultation and Assessment:
①Assess borderline cases to determine incorporation or deviation.
②Determine relationship between the investigation therapy and reported events.
③In case of observed dose limiting toxicity(DLT)and/or serious adverse evenst(SAE),lead and manage site visit for medical engagement and education/consultation,and review/submit report to the responsible internal committee.
B)Medical Review:Conduct a review of protocol,informed consent form(ICF),
Investigator's Brochure,press release and/or a report of SAE.
C)Medical Monitoring:Conduct adverse event(AE)check,baseline chest CT in lung trials.
D)Medical Education: Conduct medical,including but not limited to immune-related adverse event(irAE),education for health care providers in relation to oncology clinical development and other global and local R&D initiatives.
E)irAE Management:As a member of OSU MD Group,collaborate with all necessary functions to lead and manage external medical interactions with health care providers.

7.Operational Excellence:
A)Develop,update and maintain an internal control framework relevant to OSA responsibilities.
B)Develop,update and maintain business standards,including but not limited to written procedure,guidance,other supportive documents and tools relevant to OSA responsibilities in collaboration with corporate R&D and company functions.
C)Monitor and track progress against plan and analyze(e.g.,through feedback,After Action Review)to adjust for re-planning as necessary.
D)In addition to individual contribution,embed team-based work environment to enhance organizational capability and capacity through demonstrating our company's Leadership Behaviors.

求人情報の概要

エリア 東京都千代田区
職種 ドクター
雇用形態 正社員
給与 弊社規定に準ずる
仕事内容 オンコロジー分野で特に注目されている腫瘍免疫(Immuno-Oncology:IO)領域の開発のさらなる充実と、開発時より始まるキー・オピニオン・リーダー(KOL)と呼ばれるサイエンティフィック・リーダー/メディカル・リーダー(SL/ML)との科学的な戦略及び高度な専門性を基にした関係構築の強化、さらにはオンコロジー領域における医師主導臨床試験や日本発の市販後臨床研究(Local data generation)の推進の必要性から、こられの活動を促進する中心的な組織として、オンコロジーサイエンティフィックアフェアーズ(OSA)が新たに設立されました。
本募集では、OSAの中心として活躍できる人物を求めています。
勤務地住所 東京都
応募資格 必須条件:
Certified Medical Doctors or Ph.D.
Medical education and/or deep scientific expertise in Oncology
Expertise on logical thinking and scientific approach
Excellent communication skills to create good partnerships with SLs and internal stakeholders Having a professional mindsets with high ethics and compliance
望ましい条件、資質:
Minimum of 2 years in pharmaceutical industry,or proven industry collaboration in academia Experience in Medical/Scientific Affairs or Clinical Development
Knowledge of pharmaceutical product development,product lifecycle and business process.
Fluency in English with good oral and written communications.
Strong background of clinical and/or basic research of Oncology.
掲載期間 随時募集中

企業情報


企業名 MSD株式会社
住所 東京都千代田区九段北一丁目13番12号 北の丸スクエア
ホームページ http://www.msd.co.jp/
事業内容 MSDが販売および販売提携を行う医療用医薬品および医療機器の
プロモーション活動

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