Director/Senior Director, Clinical Research Physician, Oncology/Immunity

Provide medical oversight and support for clinical trials, ensuring studies are conducted safely, compliantly and scientifically per GCP and the protocol. Act as senior medical expert for clinical development, protocol input, medical review, safety assessment and client/regulatory interactions.

负责临床试验的医学监督与支持,确保试验按GCP和方案要求安全、合规、科学地开展,作为高级医学专家支持临床开发、方案设计、医学评审、安全评价与客户/监管沟通。

Review and provide medical input for study protocol, informed consent form (ICF), Investigator's Brochure (IB), statistical analysis plan (SAP), and other study documents.

审阅和提供医学意见于试验方案、知情同意书(ICF)、研究手册(IB)、统计分析计划(SAP)等文件。

Participate in study start-up, monitoring and closeout activities (if needed); provide medical training and support to monitors and project teams,include but not limited to investigator meeting, data monitoring committee and safety monitoring(review) committee etc.

参与研究启动、监查、关闭(如需要)等关键活动并为监查员或项目团队提供医学培训与支持,包括不限于研究者会议、数据审查委员会以及安全监查委员会等。

Conduct medical review of clinical data (listing or profile data), identify data quality or safety issues and propose remedial actions.

支持临床数据的医学审核(列表或profile数据等),识别数据质量或安全性问题并提出纠正建议。

Assess and manage adverse events (AEs/SAEs), perform medical adjudication, causality assessment and follow-up recommendations; prepare/review medical reports.

负责评估和处置不良事件(AE/SAE),对SAE进行医学判定、因果关系评估及随访建议;撰写/审阅相关医疗报告。

Communicate with site investigator,sponsors, safety monitoring(review) committee, pharmacovigilance teams and regulatory authorities on medical matters, providing timely medical advice and documentation.

与研究中心、申办方、安全监测委员会、药物警戒团队和监管机构沟通医学问题,提供及时的医学意见和文件支持。

Lead and mentor Medical Monitors/Managers and Medical Writers; organize medical training to build team capabilities

指导并监督医学监查/医学经理(以及医学写作)等,组织和提供医学培训提升团队能力

Serve as company medical representative in client meetings, support RFPs(bidding) and engage in medical communications with IRBs/ethics committees and regulators.

作为公司医学代表参与客户会议、投标(竞标)支持以及与伦理委员会/监管机构的沟通与答复。

Complete other activities or tasks assigned by Medical Head.

完成医学负责人指派的其他活动和任务。

In some case role of Safety Physician may be taken.Responsibilities :

在一些情况下,可能会承担安全医生的职责:

Conduct medical safety relevant tasks according to regulation and internal procedural documents, including product safety monitoring, review and preparation of safety report, Risk Management Plan, DSUR, PSUR etc.

根据法规及内部流程文件开展医学安全相关工作,包括不限于产品安全监测、审核/准备安全性报告,以及风险管理计划、开发期间安全性更新报告、定期安全性更新报告等。

Keep close collaboration with Medical Director/Manager (if safety physician and medical monitor are not the same person in one project), DS personnel provide in-depth evaluation and solution for safety issues.

与医学总监/医学经理(若安全医生和医学监查并非同一个人时)、药物警戒团队保持紧密协作,对安全性问题进行深入评估并提出解决方案。

Fluent verbal and written English,able to communicate with international clients and regulators

Ability to work independently and handle multiple tasks simultaneously under pressure

Successful interactions with key opinion leaders and investigators

Excellent communication skills and cross-functional coordination and problem-solving skills.

Global, cross-cultural perspectives and customer orientated

英文书面和口头表达流利,能与国内外客户及监管沟通

能够独立工作并在压力下同时应对多项任务

与关键意见领袖及研究成功沟通互动

优秀的沟通技巧、跨部门协调与解决问题能力

全球性、跨文化的视角以及以客户为导向的理念

Medicine、Pharmacy、or life sciences education background, Master's degree or above is preferred

10 years  or above working experience and 5+ years of medical monitoring or medical manager(CRO or Sponsor preferred)

医学、药学或生命科学教育背景,硕士或以上优先

10年或以上工作经验,包括5年以上医学监查或医学经理经验(在CRO或制药公司为佳)