3 个优质beigene职位（正在招聘！）

China Clinical Science Lead
Amgen —上海市
Liaison between local team and global Clinical Research Medical Director (CRMD) on partnered studies. Lead the design of clinical study protocols and execute…
Risk Based Quality Management Lead (Remote), Sr. Manager/Associate Director
BeiGene —北京市
The Risk Based Quality Management Lead will create risk assessments for any entity in clinical development, follow up on quality signals, issues and open…
Process Chemistry, (Sr.-Principal) Scientist
BeiGene —北京市昌平区
The successful candidate will independently design and implement innovative chemical syntheses and processes to support our pre-clinical and maturing portfolio.

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China Clinical Science Lead

Amgen - 上海市

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职位详情

完整职位描述

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

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beigene 个职位

China Clinical Science Lead

Risk Based Quality Management Lead (Remote), Sr. Manager/Associate Director

Process Chemistry, (Sr.-Principal) Scientist

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