Description
**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
