Immunology Clinical Development Scientist

大阪市 外資系企業 10,000,000¥ - 13,000,000¥ 外資系企業
  • Contribtute to Greater Outcomes for Patients across JAPAC
  • Develop Lifechanging Medicines within the Immunology Space

企業情報

  • Leading multinational pharmaceutical company in the field of oncology and immunology

職務内容

  • Plan and lead the implementation all study startup/conduct/close-out activities

  • Evaluate innovative trial designs (collaboration with Japan Clinical Trial Physician/Japan Clinical Development Lead)

  • Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing)

  • Site-facing activities such as training and serving as primary contact for clinical questions

  • Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team

  • Clinical data trend identification; provide trends and escalate questions to Japan Clinical Trial Physician

  • Develop clinical narrative plan; review clinical narratives

  • Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc.

  • Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities

  • Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)

  • Collaborate and serve as primary liaison between external partners for scientific advice

理想の人材

  • Licensed MD / PhD / PharmD strongly preferred
  • Native level Japanese
  • Fluent English (spoken and written)
  • Clinical practice and basic research in immunology: dermatology / rheumatoid /
  • 5 years' of experience in clinical development

条件・待遇

  • Make a meaningful impact on the lives of patients globally
  • Stable career path, overseas experience opportunities
コンタクト
Ed Marsden
求人番号
4206552
電話
+813 6832 8981

求人情報

勤務地
雇用形態
担当コンサルタント
Ed Marsden
担当コンサルタントの電話番号
+813 6832 8981
求人番号
4206552
企業タイプ