Oncology Medical Lead

2 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 global programs at the China Innovation Center of Roche (CICoR). This role will drive clinical study design, progress, data review, and interpretation, and engage with key opinion leaders, 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 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.
  • 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.
  • 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 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.

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