China Clinical Science Lead

Accountabilities

• Liaison between local team and global Clinical Research Medical Director (CRMD) on partnered studies
• Lead the design of clinical study protocols and execute clinical development as a scientific expert and medical monitor (for China/regional possiblely global studies).
• To serve as local scientific lead and medical monitor for assigned phase I-III clinical development and also post-marketing commitment studies.
• To represent Medical Sciences internally and externally, contributing local medical insight into experimental design and data analysis.
• Serve as a member of the Clinical Study Team Leadership Team (CST-LT) to provide strategic oversight and execution of clinical trials.

Responsibilities:

• Primary point of contact for partnered local development physician for assigned studies:
  • Local development POC to global CRMD and other functions and liaison between BeiGene Clinical Physician.
  • Play a China physician role to support group connection of clinical operation (BeiGene/Amgen CPO) and physician (BeiGene and CRMD/Medical Monitor).
• Serve as the medical monitor on China/regional possibly global clinical trials
• Support the development and execution for clinical trials in the China and be the local/regional medical science expert in resolving significant issues that may affect the studies
• Work closely with local/regional/global cross functional colleagues, including Clinical Operations, Biometrics, Patient Safety and Regulatory counterparts, to provide medical expertise to the study team
• Share local/regional clinical/scientific input during the development and execution of clinical trials
• Contribute or lead development of and co-author clinical study protocol and related documents for example Key Design Elements (KDE), Clinical Study Reports (CSR), and clinical scientific publications (CSP).
• Serve as a member of the CST-LT, provide medical and strategic oversight to the study execution. 
• Monitor, analyse, and interpret clinical study data
• Contribute to the preparation of documents required for regulatory submissions
• Develop and interface with local/regional industry key opinion leaders and manage scientific presentation at advisory boards, key scientific meetings and external committee meetings
• Participate in interactions with regulatory agencies
• Ensuring compliance with GCP across clinical trials

Output

• Ensure local/regional/global clinical studies are adequately and timely supported and executed
• Ensure medical support leading to successfully submission and approval of CTNs and MAAs
• Establish and maintain appropriate relationship with local/regional industry key opinion leaders and medical communities
• Co-authorship of clinical, regulatory and safety documents
• Medical review and input to study related documents
• Authorship of clinical scientific publications

Skills and Qualities

• MD degree from an accredited medical school, and experience in patient care required
• Minimum 5 years of clinical research experience in academia and/or biopharmaceutical industry (biotech, pharmaceutical or CRO company)
• Demonstrate in-depth knowledge in specific therapeutic area
• In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale
• Familiarity with concepts of clinical research and clinical trial design, including working knowledge of statistics as applied to clinical trial design and analysis
• Previous experience in early and/or late stage clinical trials and regulatory filings
• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
• Experience in writing and editing scientific research reports
• Thorough understanding of GCP and familiarity with relevant NMPA and ICH guidance
• Ability to collaborate effectively in and/or lead cross-functional teams
• Strong commitment to goals and timelines
• Ability to absorb new information quickly and gain command of relevant literature
• Possessing excellent problem-solving & decision-making skills
• Excellent written and verbal communication skills, including fluency in English