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Senior Physician I/II – Clinical Trials (GU)

AstraZeneca · Shanghai

Senior 🇬🇧 English
medical monitoring regulatory filing drug development

Job description

About the role

The Senior Physician I/II (GU) will lead medical activities for clinical studies conducted in China, supporting both global and country‑specific programs. Reporting to the study lead physicians, the role ensures scientific integrity, participant safety, and regulatory compliance throughout the trial lifecycle.

Key responsibilities

  • Take medical responsibility for the conduct and integrity of all in‑scope clinical studies.
  • Participate as the China study physician on global, PK, and local clinical initiatives.
  • Contribute to study design, protocol development, and amendments to align with Chinese practice and regulatory requirements.
  • Provide medical monitoring, review safety data, evaluate AEs/SAEs, and detect safety signals.
  • Support preparation of regulatory filing documents and act as a clinical science expert for TA registration.
  • Advise clinical operations on protocol questions and respond to site investigators.
  • Maintain communication with global study teams and Chinese KOLs for protocol design and development plans.
  • Coach junior colleagues and stay current on medical, scientific, and competitive intelligence.

Required profile

  • Master’s degree in a medical discipline (PhD preferred).
  • Minimum 3 years of physician experience in drug development within a pharmaceutical company.
  • Proven experience in managing and designing clinical trials across drug development phases.
  • Strong knowledge of study analysis, design, and regulatory requirements.

Required skills

  • Clinical trial design
  • Medical monitoring and safety evaluation
  • Regulatory filing preparation
  • Drug development processes
  • Adverse event assessment

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Published 2个月前

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AstraZeneca

Shanghai