Principal/Associate Director, Physician (Cell Therapy)

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  • 上海,北京

Typical Accountabilities:

  • Ensure successful conduct and integrity of all in-scope clinical studies (i.e., providing medical monitoring)
  • Co-owners of clinical study delivery (with Stats and Clinical Operations)
  • Development documents (CIB, protocol and CSR, ETC) content owner
  • Analysis and interpretation of clinical study results in partnership with BIS, Clinical Operations and Safety (as well as Clinical Pharmacologist If necessary)
  • Forming and running advisory board for portfolio projects; Be responsible for interacting and communicating with China KOLs for China development strategy and protocol design
  • Liaise with safety physician for program-level assessment of safety information, evaluation of safety signals, regulatory compliance of safety reporting Liaise with clinical pharmacologist on PK/PD programs to ensure the deliverables
  • Protocol development preparation for review by the Clinical Challenge and Protocol Review Committee
  • Setting strategic direction for addressing medical issues in regulatory submission and communication/interaction
  • Be a TA clinical science expert and supporting China regulatory filing and registration
  • Be a TA clinical science expert and leading discussions with regulatory officials on clinical science subjects of a given project
  • Be the clinical science physician and providing consultation to clinical operation colleagues on protocol design questions and answering protocol related questions from site investigators
  • A core function on China Product Team representing TA Clinical Science
  • Be the interface with GPT MSD/physicians on clinical sciences matters
  • Provide clinical science support to BD and AZ China projects on needed base
  • Liaise with MA and BD to support pre-launch marketing activities, publications, conferences and early market access to the compounds 
  • Maintain up-to-date medical/scientific knowledge as well as clinical trial landscape and competitive intelligences in the TA


Education, Qualifications, Skills and Experience:

  • Major in Clinical Medicine and M.D. or Ph.D.
  • Minimum 6 years of experience as clinical research
  • physician in pharma industry
  • Therapeutic area expertise in Cell-Therapy/Immunology/Oncology
  • Compound knowledge
  • Regulatory guidance for the TA
  • Medical monitoring
  • Safety reporting and Risk Management Plan
  • CSP/CSR content & data analysis
  • Presentation & communication skill
  • Prioritize and focus with attentive to detail and excellent analytical skill