以上为北京时间。链接检查不代表仍在招聘，申请前请以招聘官网为准。
按这个岗位的城市和方向提醒，确认后才开启，可选择每日或每周。
负责为临床试验各阶段提供医学专业支持，包括研究设计、方案开发、执行及医学监查。领导肿瘤项目临床开发计划与注册策略的制定，审阅各类医学文件并确保数据质量与受试者安全，建立并管理医学团队。
This role is responsible for providing
medical expertise on different stages of clinical trials to accelerate the fast
growth of Duality, including study design, protocol development, execution,
medical monitoring, as well contributing to clinical development planning and
strategy.
l Assist Set up and build up the medical team to per
business needs
l Ensure that projects are carried out within the
set timeline, quality standards and budget, and in accordance with business
requirements;
l Lead the development of clinical development
plans, proof-of-concept strategies, and registration strategies for oncology
projects, keep the CDP up to date by regular review;
l Oversight or leads the development of clinical
study protocol synopsis, protocols, and protocol amendments, medical documents,
such as IB, CSR, MMP etc. Review and approve other function documents that need
medical input, such as ICF, CRF, PD documents, SAP, DVP, dry run, DSUR etc.
Contributes to the clinical sections of the IND/NDA/BLA CTD, briefing packages
for regulatory meetings;
l Lead and/or conduct medical monitoring to ensure
data review quality (e.g. participant eligibility review, Protocol Deviation
review, efficacy and safety review such as efficacy variable; Adverse Events
(AEs); Concomitant medications), participant safety and data accuracy;
l Ensure comprehensive safety review and safety
follow up;
l Where possible (appropriate language skills
exist), check critical items in the translation (e.g. clinical/preclinical
research terminology) and provide comments back to the translation vendor.
l Oversee function-related vendor selection and
supervise medical related work regardless of whether it is implemented in-house
or out-sourcing to third party organizations;
l Answers medical questions raised by HA/EC/IRBs
and sites; identifies the need for protocol amendment and maintains appropriate
compliance with protocols;
l Lead or participate in the elaboration of
training material and presentations at the investigator meetings, advisory
committee meetings, and steering committee meetings;
l Establish good relationship with the KOL’s and
set up the regular or ad hoc ad board and consultation meeting;
l Support CMO to develop and maintain the SOPs/WIs
to meet the business needs if required
l Report the team key progress, key issues/actions
to the CMO and company senior management team;
Other work as assigned by the company.
任职资格/Qualifications:
l Master degree and above in clinical medicine.
l Physician background is a must. At least 3 years
clinical doctor experience is preferred.
l At least 5 years of experience in clinical
research or relevant experience, clinical trials experiences preferred
l Solid GCP, medical monitoring experience
l Solid protocol development/medical related
documents, such as protocol synopsis, IB, CSR etc. experience, solid medical
monitoring experience
l Strategic thinking by actively seeking
information to develop optimal clinical development strategy for registration
l Advanced disease knowledge is preferred
l Native Chinese Speaker
l Skills in communication, problem-solving and risk
management
l IND/NDA experience in China and ex-China is
preferred
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