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。
负责肿瘤临床试验的医学策略制定与执行，包括方案设计、医学监查及注册申报；领导医学团队，管理项目进度与质量；与KOL及监管机构沟通，推动产品快速上市。
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 Set up and build up the medical team to meet the
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 participates in the elaboration of
training material and presentations at the investigator meetings, advisory
committee meetings, and steering committee meetings;
l Establish good relationship with KOLs 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
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 10 years of experience in clinical
research or relevant experience, clinical trials experiences preferred
l Solid protocol development/medical related
documents, such as 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 Excellent verbal and written skills in English
l Skills in communication, problem-solving and risk
management
l IND/NDA experience in China and ex-China is
preferred
Traits:
1. Strong ownership and high
engagement
2. Strategic thinking for the
drug development strategy
3. Results driven with solid
problem solving and time management skills
4. Great interpersonal skills
5. Strong attention to detail.
Highly organized
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