默沙东
Sr. Manager, Clinical Research
Sr. Manager, Clinical Research
发布于 大约 14 小时前中层管理(经理/总监)
北京市
高级经验
全职员工
仅现场办公
博士
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
肿瘤学
关键意见领袖
跨国团队协作
AI 估算 · 30k–50k
资深临床研究管理岗，外资药企北京核心岗位，高学历要求，薪资竞争力强。
职位详情
关于这个职位
作为临床研究高级经理，您将领导中国区的早期临床研究，与全球团队合作推动新药注册
您需要设计临床试验方案、与关键意见领袖沟通、准备研究报告和注册档案，是连接中国研发中心与总部的关键接口
该职位要求深厚的医学背景和肿瘤学经验，非常适合希望在跨国药企核心研发岗位发挥领导力的资深临床专家
最低要求
A PHD/Master in clinical medicine (at least 5-year medical school graduates) with postgraduate training in oncology or relative major.
Deep understanding of China regulatory environment and clinical development procedure.
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
Clinical research physician will play a key leadership role for the clinical development in China. This individual will be responsible and accountable for the development of best China development plan. Clinical research partners closely with headquarter project development team, China regulatory affair, project management, clinical trial operation team for flawless plan and execution of early clinical studies in support of eventual registration. This individual is expected to be responsible for different programs across therapeutic franchise.
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.
优先资格
Previous experience of clinical research/clinical development is highly desirable, including strategy development, medical monitoring, and protocol/writing.
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