The job holder design and ensure successful conduct of clinical studies and review study results. He/she is core members in project team and responsible for compound’s development strategy and plan.

• Development strategy and plan (including protocols) for all portfolio projects
  

· Ensure successful conduct and integrity of all in-scope clinical studies (i.e., providing medical monitoring) · Co-owners of clinical study delivery

• Development documents (CIB, protocol and CSR, ETC) content owner
• Analysis and interpretation of clinical study results in partnership with clinical development functions
• Forming and running advisory board for portfolio projects;

Be responsible for interacting and communicating China KOLs for 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 including updating safety profile in the Investigator’s Brochure, Risk Management Plan, DSUR, etc.
• Liaise with clinical pharmacologist on PK/PD programs to ensure the deliverables

· Setting strategic direction for addressing medical issues in regulatory submission and communication/interaction · Be a clinical science expert and supporting regulatory filing and registration

• Be a 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
• Liaise with other functions 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

Academic / Professional Qualification 学历要求

• Medical Degree

Technical / Skills Training技术资质

• Disease Knowledge
• Patient journey
• Treatment guidance
• Compound knowledge
• Regulatory guidance for the therapy area
• 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

Working Experience工作经验

3-5 years of clinical development experience (at least as clinical research physician for 3 years) in pharmaceutical and/or biotech industry

上班地址：亮景路199号