辉瑞
Associate Director, Clinician
Associate Director, Clinician
发布于 大约 15 小时前中层管理(经理/总监)
上海市
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
跨部门协作
监管事务
临床试验
临床开发
药物安全
医学监督
Md
AI 估算 · 50k–80k
资深医学总监岗位，辉瑞跨国巨头，上海核心区域，薪酬位于行业顶尖水平
职位详情
关于这个职位
作为辉瑞临床开发团队的医学总监，你将全面负责临床开发计划的医学监督与战略指导
您需要与全球研究者、监管机构及内部团队紧密协作，确保临床试验的设计、执行与数据解读符合最高标准
该职位要求深厚的医学背景与丰富的临床研究经验，是推动创新药物上市的关键角色
最低要求
M.D. 或同等医学资格（参照全球临床领导团队对“医学资格人员”的定义）
工作职责
Review and oversight of the adequacy of other clinical assessments (as appropriate).
Clinical development plan, clinical protocol development, study planning and initiation.
Provide medical input during development and updates to the clinical development plan. Provide medical input during clinical protocol development and Informed Consent Document (ICD).
Medical review of country feedback during protocol feasibility to ensure understanding and mitigation of any feedback which may impact future protocol compliance, risks to subject safety or data integrity (e.g. understanding of local standard of care and impact on ability to execute clinical protocol). This is performed in collaboration with the Regional Clinical Site Leads (RCSLs) if they are assigned to the clinical trial.
Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level.
Provide medical input to the study team for study specific control plans (e.g. study monitoring plans, ICDs, data edit checks, safety review plan and, if RCSLs are assigned to the study, the RMM Medical Oversight Plan).
Ensure medical requirements are accurately defined (e.g. lab specifications) during CRO/vendor selection to ensure study is conducted consistent with protocol requirements and/or clinical development plan expectations.
Site interactions: Develop and maintain peer to peer relationships with healthcare professionals at clinical trial sites (in collaboration with RCSLs when assigned to a study). Participate and lead site staff training or retraining when medical input is required (e.g. Investigator meetings, study site initiation visits, protocol specific training, training in response to other medical issues that may arise). Interact with healthcare professionals at sites (leveraging the RCSLs when assigned) during the conduct of the study to enable quality, compliance and patient safety at the trial, site and patient level. Act as a point of contact for medical questions at site level and responsible for clarifications to site personnel regarding interpretation of protocol and medical practice, leveraging the RMM organization if assigned to the study.
Other external interactions: Participate in medical interactions with opinion leaders, regulatory agencies and payers in development of clinical plan and protocols. Interact (as applicable) with data monitoring committees, endpoint adjudication committees and steering committees when medical questions/problems are surfaced which require feedback input from the study team.
Study team and/or clinical program interactions: Develop, participate and lead study team training or retraining when medical input is required (e.g. protocol specific training, training in response to other medical issues that may arise). Conduct medical review and interpretation of efficacy and safety data during study conduct, including regular review of individual subject safety data and review of cumulative safety data with the safety risk lead (when assigned to a clinical program) consistent with the Safety Review Plan. Oversight and, as necessary, remediation of risks identified during risk assessment and mitigation planning which require oversight by a medically qualified individual. Provide project team with medical advice for other program related activities which are not related to a specific clinical study (e.g. interpretation of preclinical data). Review on a regular basis SAE reports for early identification of potential safety issues. Liaise regularly with RMMs when assigned to the study to ensure knowledge sharing and global consistency in medical oversight activities. Medical review of efficacy and safety data in support of development of top-line report and clinical study report in collaboration with the study team, particularly with regards overall conclusions on safety, efficacy and benefit-risk assessment. Provide medical advice and oversight to the study team or clinical program in response to audits or inspections, including providing medical advice and support for audit/inspection responses (e.g. site visits if specific medical expertise is required to further investigate or remediate findings). May co-author abstracts, posters, presentations and publications.
Technical/Behavioral Competencies: Proven ability to get results in a matrixed management environment. Knowledgeable of the commercial and environmental issues that drive clinical programs. Regulatory awareness – proven track record of proactive management of regulatory issues related to protocols and programs, including comprehensive experience of interactions with regulatory authorities.
AI 洞察
优缺点分析
优点
- 辉瑞作为全球制药巨头，平台资源丰富，能参与重磅创新药研发
- 职位级别高（Associate Director），拥有决策权和行业影响力
- 工作涉及多学科协作，能积累广泛的人脉与经验
- 工作强度较大，需同时负责多个项目，且频繁应对差旅和会议
- 对法规和合规要求极高，需持续学习并应对复杂监管环境
- 矩阵管理环境要求高情商与协调能力
- 适合拥有深厚医学背景、热爱临床研究、并希望在大型药企承担领导角色的资深医学专业人士
缺点 / 挑战
暂无明显挑战项
角色解读
- 可晋升至更高级别医学总监或全球临床项目负责人
- 横向可转向药物警戒、医学事务或研发战略岗位
- 在辉瑞这样的跨国药企中，有国际化职业发展机会
- 负责临床开发计划的医学策略制定与监督，确保试验方案科学合规
- 与全球研究者、监管机构及KOL建立并维护合作关系，参与外部学术互动
- 审阅临床数据（安全性与有效性），为团队提供医学决策支持，并主导培训
- 必须具备MD或同等医学学位，有扎实的临床医学知识
- 丰富的临床试验医学监督经验，熟悉GCP和ICH指南
- 出色的跨部门沟通与矩阵管理能力，能推动多方协作
申请策略
- 了解辉瑞当前的重点治疗领域（如肿瘤、疫苗），在面试中展示相关经验
- 准备好分享您如何解决复杂医学问题的具体案例
- 突出您的MD学位及临床医学资格
- 详细描述您主导过的大型临床试验医学监督经验
- 强调与监管机构（如NMPA、FDA）成功互动的案例
- 熟悉ICH-GCP和最新法规更新
- 提升数据分析能力，特别是安全性数据审阅
面试指南
- 使用STAR法则（情境、任务、行动、结果）结构化回答，强调您的医学判断、沟通能力和领导力
- 请举例说明您是如何处理一个临床试验中的重大安全性事件的？
- 描述一次与监管机构有争议的互动，您是如何应对的？
- 您如何平衡多个项目的医学监督优先级？
- 您如何确保全球临床试验中不同地区医学实践差异的合规？
- 准备2-3个您亲自参与的项目案例，突出您的角色和贡献
- 复习当前辉瑞的主要管线及公开的试验数据
- 熟悉FDA和NMPA最新指南
职位点评
64
综合评分
辉瑞资深医学总监，高薪高社会影响力，但工作强度大且需现场办公。
更适合这类人
适合追求职业成就与社会价值、能接受高强度工作的资深医学人才。
表现最好
使命价值
相对薄弱
工作生活
薪资福利70
成长发展60
工作生活40
使命价值85
薪资福利
70中等
辉瑞提供行业领先的薪酬和福利，但JD未明确具体数字，影响评分确定性。
薪资信号未披露（AI估算：50K-80K/月）
成长发展
60中等
职位有明确的成长路径和跨部门学习机会，但要求经验资深，技能提升空间有限。
技术前沿非技术岗（不适用）
业务类型ambiguous
工作生活
40较低
现场办公且可能涉及差旅，未提及弹性工作，生活方式挑战较大。
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
医药行业对社会健康有直接贡献，辉瑞处于创新前沿，使命感强。
行业发展高速增长赛道
社会影响正向社会影响力较高
创新程度积极采用新技术
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