默沙东
Manager, Clinical Research
Manager, Clinical Research
发布于 大约 8 小时前中层管理(经理/总监)
北京市 / 上海市
高级经验
全职员工
仅现场办公
硕士
医疗、制药与临床研究
项目管理
领导力
英语
监管事务
临床研究
中文
KOL管理
药物开发
肿瘤学
AI 估算 · 35k–55k
外企临床研究经理岗位，硕士以上学历要求，北京上海一线城市，结合行业薪资水平，预计月薪35k-55k
职位详情
关于这个职位
该职位是默沙东中国早期临床开发团队的临床研究经理，负责领导创新临床研究项目，助力全球药物注册
您将作为总部与中国团队的桥梁，主导研究方案设计、与关键意见领袖合作、撰写报告并准备监管申报材料，推动肿瘤等领域的新药开发
最低要求
Requirement:
A PHD/Master in clinical medicine (at least 4-year medical school graduates) with postgraduate training in oncology or relative major.
Deep understanding of China regulatory environment and clinical development procedure.
Previous experience of clinical research/clinical development is highly desirable, including strategy development, medical monitoring, and protocol/ writing.
The candidate who is ideally suited for this position will be bright, driven, dedicated, persistent, strategic, flexible, clever, and resourceful.
The candidate should have a strong leadership, excellent written and oral communication skills, and project management skills.
Strong capability of work prioritization and deliver results with parallel multiple tasks.
Excellent language skills in both English and Chinese (fluent in verbal and written).
The position may require the flexibility to work outside of the area of primary medical specialization.
工作职责
This individual will serve as the key interface between headquarter project development team and China development center. The clinical research physician is expected to abstract high level relevant clinical and preclinical data and effectively use these data in support of study design. The clinical research physician will represent clinical development team of China development center on headquarters project team as needed and this individual is expected to address issues/questions raised by headquarters team and provides feedback to headquarters project team from China perspective. This individual should have excellent communication skill with demonstrated language skills in both written and verbal English and Chinese.
Whenever Clinical Research designs a clinical study, the clinical research physician (clinical monitor) is expected to drive study design, and collaborate with biostatisticians, regulatory affairs, and other relevant disciplines to construct a high-quality clinical study protocol. We place high value on efficient, feasibility, most desirable labels, and cost effective, necessitating careful collaboration with operational experts such as colleagues from global clinical trial operation. The clinical monitor will interpret, prepare clinical study reports, regulatory dossier, regulatory responses, and review product label. The clinical research physician will also prepare and review manuscript for publication. In this role, this individual will work with study team to ensure safety/efficacy information adequately captured and review serious adverse events. Clinical research physician will review and approve monitoring plan/reports/data listings.
The clinical research physician will also work as clinical scientist, to lead lab selection and clinical supply application during study planning phase, and investigator meeting during study initiation phase, and review protocol deviation and answer protocol related questions during study implementation phase.
To develop the best, most suitable clinical plan and protocol, the clinical research physician is expected to engage scientific leaders and internal key stakeholders such as medical affair, and marketing and regulatory affair etc. The clinical physician will be involving in introducing new compounds in development to China scientific leaders and seek feedback for our clinical development plan as needed.
The clinical research physician will participate due diligence evaluation as expert for medical related matter. Clinical physician is also working closely with medical affair to identify gap/opportunities of patient care in China and develop clinical plan/study to capitalize the emerging opportunities.
AI 洞察
优缺点分析
优点
- 默沙东作为全球顶级药企，平台资源丰富，能参与前沿创新药开发，提升专业影响力
- 职位兼顾临床与策略，技能积累全面，未来职业发展空间大
- 与总部及全球团队合作，锻炼跨文化领导力，增强国际视野
- 需同时管理多个项目，工作强度较大，要求高效的时间管理和多任务处理能力
- 对中英文沟通能力要求极高，需频繁与总部及国内部门协调
- 适合拥有临床医学博士或硕士学位、具备肿瘤学背景、希望在跨国药企从事早期创新药临床开发并具备领导潜力的资深专业人士
缺点 / 挑战
- 早期临床研究涉及较高的不确定性，需应对复杂监管环境和科学挑战
角色解读
- 在跨国药企积累创新药早期开发经验，未来可晋升为高级临床研究经理或临床开发总监
- 通过领导关键项目，深入了解全球药物注册策略，向研发高管方向发展
- 掌握多治疗领域知识后，可转型为医学事务或监管事务负责人，拓宽职业路径
- 负责早期临床研究的设计与执行，包括开发研究方案、撰写临床研究报告和监管申报文件
- 作为总部与中国的关键接口，沟通协调跨国项目，确保中国研发计划与全球战略一致
- 与统计学家、监管事务、运营团队及外部KOL合作，推动高质量临床研究
- 参与新药引进的尽职调查，并识别中国患者护理的差距与机遇
- 临床医学背景（博士或硕士），肿瘤学专业优先，具备扎实的医学知识
- 深刻理解中国监管环境和临床开发流程，有策略制定和医学监查经验
- 优秀的领导力、沟通能力和项目管理能力，能同时处理多个任务
- 中英文流利（书面和口语），能有效进行跨文化沟通
申请策略
- 深入了解默沙东的研发管线和中国战略，在面试中展示您的行业见解
- 准备具体案例说明您如何解决复杂的临床开发问题，体现策略思维和执行力
- 突出您的临床医学教育背景和肿瘤学专科训练，以及过往临床研究或开发经验
- 强调您领导或参与的临床研究项目，特别是策略制定、方案撰写和监管申报成果
- 展示您的领导力案例，如带领团队、管理多个项目或跨部门协作
- 提供中英文写作和口语能力的证明，如发表文章或国际会议演讲
- 若经验不足，可争取参与早期临床研究项目或内部培训，加深对IND/NDA流程的理解
- 加强项目管理技能，学习PMP或相关认证，提升任务优先级管理能力
面试指南
- 使用STAR法则（情境-任务-行动-结果）来结构化回答，重点突出您的领导作用
- 展示您对监管环境和科学前沿的理解，将方法论与具体实践结合
- 体现您跨部门协作和沟通能力，强调语言优势和文化适应力
- 请描述您领导或参与过一个临床研究方案的设计过程，以及您如何协调各方意见
- 您如何确保中国临床开发计划与全球战略一致？请举例说明
- 在面对短期项目冲突时，您如何优先分配资源和时间？
- 您如何与关键意见领袖（KOL）建立合作关系并推动研究？
- 请谈谈您对肿瘤领域最新进展的看法，以及如何将其应用于早期临床开发
职位点评
76
综合评分
外企顶尖临床研究管理岗，发展空间极大，但工作强度高，WLB一般。
更适合这类人
最适合追求专业成长和职业发展的求职者，尤其是希望在创新药早期开发领域积累国际经验的医学专家。
表现最好
成长发展
相对薄弱
工作生活
薪资福利80
成长发展90
工作生活50
使命价值85
薪资福利
80较高
该职位薪资水平在行业中属于高端（外企经理级别），福利完善，但JD未明确薪资范围，薪资信号偏向未披露。
薪资信号未披露（AI估算：35K-55K/月）
成长发展
90较高
职位提供参与全球创新药早期开发的巨大成长空间，涉及多领域合作，技能提升显着，但JD未明确提及晋升通道。
技术前沿前沿/新兴技术
技术栈临床研究、肿瘤学、监管事务、研究方案设计
成长机会leadership
业务类型ambiguous
工作生活
50较低
工作地点在朝阳北京和上海，市区核心地段，但要求弹性加班（未明确WLB），且需要跨时区沟通，生活方式平衡性一般。
工作模式仅现场办公
办公地点市区核心地段
加班情况未提及（无法判断）
使命价值
85较高
工作直接参与创新药物开发，改善患者健康，社会价值高，行业增长强劲，但JD未重点强调使命感。
行业发展高速增长赛道
社会影响正向社会影响力较高
使命信号innovative clinical research
创新程度积极采用新技术
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