Clinical Development Lead - Oncology - MD

東京23区 外資系企業 年収 1500万円 - 2000万円 外資系企業 在宅可・ハイブリッド勤務可
  • Contribtute to Greater Outcomes for Patients across Japan and Overseas
  • Directly Impact the Development of Life-Saving Therapies within Oncology

企業情報

  • European headquartered pharmaceutical company with innovative development pipeline for oncologic diseases

職務内容

  • Serves as a primary source of medical accountability and oversight for clinical trials
  • Matrix management responsibilities across the internal and external network
  • Manages Phase 1 - Phase 3 studies, with demonstrated decision making capabilities
  • Provides medical and scientific expertise to cross-functional colleagues
  • Contributes to and is a key member of a high performing Study Delivery Team (SDT) and is a member of the Japan Clinical Development Team (J CDT)
  • Conducts medical data review of trial data, including eligibility review
  • Holds responsibility for site interactions in partnership with the Japan Clinical Scientist (CS) for medical questions and education (including safety management guidelines)
  • Holds responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives
  • Collaborates with Japan CS and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)
  • Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
  • Assist global clinical trial physicians, provide local medical related input, resolve local medical related issues.
  • In collaboration with the Japan Clinical Development Lead, designs and develops clinical plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets
  • Provides oversight and medical accountability for a group of studies
  • Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Japan CS
  • Partners with Japan CS to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
  • Identifies and builds relationships with principal investigators. Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs
  • Maintains a strong medical/scientific reputation within the disease area. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. Keeps up-to-date in the disease area by attending scientific conferences and ongoing review of the literature
  • Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape
  • Provides ongoing medical education in partnership with CS to allow for protocol-specific training, supporting the study team, investigators, and others
  • Contributes to key Health Authority interactions and advisory board meetings as Clinical Trial Physician
  • Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with Clinical Scientists
  • Proactive identification of potential risks and development/implementation of actions to avoid or mitigate and able to make the appropriate trade-offs of balancing risks with study deliverables and costs.
  • Maintenance/updating of data as appropriate in project management tools including CTMS
  • Informing operational program lead/s and other leadership (as appropriate) on overall clinical trial plans, updated forecasting, and of potential issues/mitigation
  • Facilitation of site feasibility/selection processes with use of robust data
  • Operational and strategic input into study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc.
  • Oversight of investigational product [IP]supply forecasting/management and study-level IP reconciliation [in collaboration with IMSC] and recommend appropriate trade-off to balance risks and study execution deliverables.
  • Development of the subject recruitment/retention strategy and related initiatives
  • Participation in clinical service provider (vendor) selection, specification development, and management/oversight



理想の人材

  • Licensed MD
  • Native level Japanese
  • Business level English
  • Pharmaceutical industry experience not necessary
  • Clinical practice and basic research in oncology/cancer preferred

条件・待遇

  • Have a wide impact on patients across Japan and further afield
  • Meaningful position in a major global company
  • Stable career path, overseas experience opportunities
  • Expand medical expertise beyond clinical practise to medical affairs, clinical development and pharmacovigilance
コンタクト
Ed Marsden
求人番号
JN-022024-6323687
電話
+813 6832 8981

求人情報

分野
ライフサイエンス
職種
研究開発
業界
ヘルスケア・製薬
勤務地
東京23区
雇用形態
正社員
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
JN-022024-6323687
企業タイプ
外資系企業
勤務形態
在宅可・ハイブリッド勤務可

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