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Shanghai

    Oncology Medical Lead/Clinical Scientist - Shanghai, 中国 - Roche

    Roche
    Roche background
    全职
    描述

    The Position

    The medical lead or principle/senior clinical scientist at the Early Development (ED) department of the China Innovation Center of Roche (CICoR) is responsible for providing medical/clinical expertise in the early clinical development strategy of a CICoR governed global program, driving clinical study design, progress, clinical data review and interpretation, and engaging KOLs, investigators and regulatory agencies; may also act as local medical/clinical expert to support clinical development in China for programs from other Roche research centers.

    Principle Roles & Responsibilities / Accountabilities

  • Provide/lead medical/clinical strategy as a critical part of the drug early development project strategy for CICoR programs, key member in Early Development Teams driving projects from clinical candidate selection to full clinical development
  • Provide scientific guidance to the drug research and development strategies across multiple R&D stages, contribute to CICoR discovery project objectives and activities target assessment, translation, and landscape)
  • Develops and own the Clinical Development Plan (CDP) with a vision for CDP from early development to decision to file
  • Drive clinical study design, progress, data review, interpretation and report; lead the development and writing of study protocol, study report and other responsible documents
  • Key-contributor to response to questions from regulatory agency/institutional review boards (IRB); input to and review clinical regulatory documents
  • Assist in the management of studies and support the training and scientific input to clinical operation and study site staff
  • Support clinical safety in the serious adverse events reporting process
  • Provide local medical/clinical assessment for China's early participation in global clinical trials
  • Represent Roche at congresses and to local and international authorities, contribute to internal and external presentations CICoR early development committee (EDC) meeting, advisory board meeting)
  • Ensure GCP compliance in assigned pharma research and early development studies
  • Qualification and Experience

    Education/Qualifications

  • MD (preferred) / PhD / PharmD (or equivalent)
  • Five or more years of experience in clinical research in Pharma / Biotech industry
  • Clinical research experience in oncology
  • Leadership Competencies

  • Excellent interpersonal skills and collaborative attitude
  • Have a highly self-motivated and innovative mindset to design and/or generate key data
  • Good organizational and multi-tasking abilities to ensure quality and timely delivery of the project deliverables
  • Job Required Competencies

  • Excellent understanding of all aspects and scientific methods used in Translational Medicine
  • Role model and established reputation in area of expertise
  • Knowledge of the drug development processes within the context of pharmaceutical industry
  • Good track record of scientific excellence that has significantly impacted research and development of drugs
  • Recognized by peers for scientific excellence, maintains external scientific presence through high quality publications and presentations

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