Oncology Medical Lead/Clinical Scientist

4 weeks ago

Shanghai, Shanghai, China Roche Full time

Job Summary

The Medical Lead/Clinical Scientist will provide medical/clinical expertise in the early clinical development strategy of a global program, driving clinical study design, progress, clinical data review and interpretation, and engaging KOLs, investigators and regulatory agencies.

Key Responsibilities

  • Develop and lead medical/clinical strategy as a critical part of the drug early development project strategy for CICoR programs.
  • Provide scientific guidance to the drug research and development strategies across multiple R&D stages.
  • Develop 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.
  • Key-contributor to response to questions from regulatory agency/institutional review boards (IRB).
  • 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.

Qualifications and Experience

  • 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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