募集要項

グローバル研究開発本部


 

ジャパンオンコロジーサイエンスユニット オンコロジー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 クリニカルリサーチ
Associate Principal Scientist Clinical Research, Oncology Scientific Affairs (OSA), Oncology Science Unit (OSU), Japan Development (JD)

OSA Mission
As trusted medical science experts, Oncology Scientific Affairs (OSA) proactively and strategically engage scientific exchange and support clinical development to improve cancer medical treatment. In alignment with the OSA strategy, key responsibilities of OSA are as follows:

募集要項

 

 



職務内容
  • 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 (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:
      • ① Assess borderline cases to determine incorporation or deviation.
      • ② Determine relationship between the investigational therapy and reported events.
      • ③ In case of observed dose limiting toxicity (DLT)and/or serious adverse event (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.
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.
勤務地 本社 九段下
勤務時間 7時間45分/日(所定労働時間)
休日・休暇 完全週休2日制(土日)、祝日、年末年始、創立記念日、年次有給休暇、夏季特別休暇等
給与 当社規定に準じる
昇給 年1回 (4月)
賞与 年1回 (3月)
諸手当 通勤手当、住宅手当等
保険 各種社会保険
制度 借上社宅制度/退職金制度/財形貯蓄制度/保育料補助制度 等
応募方法 ホームページ所定フォームよりご応募ください
メールにて職務経歴書(書式自由)をお送りください
ご相談

業務内容、応募要件の確認や、選考プロセス(ご来社が難しい海外・国内遠方等のケース)入社時期調整等々。ご応募前のご相談・事前情報収集として、お気軽に問い合わせください。
<ご相談受付>こちらのメールにご連絡ください。