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Clinical Trial Physician (CTP)

Bristol Myers Squibb · Shanghai

🇬🇧 English
dose escalation clinical dossier preparation

Job description

About the role

The Clinical Trial Physician (CTP) joins Bristol Myers Squibb’s Medical Monitoring team to provide medical oversight across Phase 1‑3 oncology studies. Working within the Study Delivery Team, the CTP ensures rigorous safety review, supports dose‑escalation decisions, and collaborates with cross‑functional partners to drive timely, compliant trial execution.

Key responsibilities

  • Lead ongoing medical review of clinical trial data, including eligibility and key safety assessments.
  • Coordinate with Clinical Operations, Pharmacology, Translational Medicine, Biometrics, and Patient Safety to align on data review and risk mitigation.
  • Provide end‑to‑end medical oversight from First‑in‑Human dose escalation through Phase 3, including real‑time safety signal evaluation and dose recommendation.
  • Prepare safety packages and documentation for Safety Review Committee and Dose Escalation Committee meetings.
  • Contribute clinical input to filing strategies, dossier preparation, and GCP inspections.
  • Assess serious adverse events in partnership with Worldwide Patient Safety and author safety narratives.
  • Support protocol development with safety‑focused inclusion/exclusion criteria and other clinical considerations.

Required profile

  • Medical degree with board certification in a relevant specialty (e.g., Oncology, Internal Medicine).
  • Extensive experience in clinical trial medical monitoring, preferably across Phase 1‑3 studies.
  • Strong understanding of GCP, regulatory requirements, and safety data interpretation.
  • Proven ability to work collaboratively in cross‑functional, global teams.

Required skills

  • Good Clinical Practice (GCP) compliance
  • Clinical trial data review and safety monitoring
  • Dose escalation and dose‑decision support
  • Safety Review Committee documentation
  • Clinical dossier preparation for regulatory submissions

What we offer

  • Opportunity to work on innovative cell‑therapy and oncology programs.
  • Access to a global network of high‑performing scientific and medical experts.
  • Comprehensive benefits supporting work‑life balance and professional growth.

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Published 1个月前

Expires 1周后

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Bristol Myers Squibb

Shanghai