辉瑞
Senior Clinical Research Clinician
Senior Clinical Research Clinician
发布于 4 小时前普通员工/个人贡献者
全职员工仅现场办公临床研究
临床研究
临床方案设计
临床试验
医学联络官
数据解读
监管合规
药物开发
项目管理
风险管理
值不值得投
75综合评分
综合评分 75
高专业壁垒的顶尖药企临床研发岗，发展性与意义感突出，但工作模式灵活度可能有限。
从薪资福利、成长空间、工作节奏和岗位方向综合评估，方便横向比较。
薪资怎么样
4万
与临床研究中位数基本持平
发布情况
新岗位 · 今天发布
公司情况
这家公司招聘很活跃
约 240 个在招
市场机会
选择面较广
上海 · 临床研究 · 约 110 个在招
职位详情
关于这个职位
该职位是辉瑞（Pfizer）的高级临床研究医生（Senior Clinical Research Clinician），负责领导和执行一项或多项临床试验的全流程
工作核心是确保临床研究设计科学、执行合规、数据可靠，并代表公司与研究机构、监管方进行专业沟通
需要深厚的临床医学、药学或相关科学背景，并具备丰富的临床试验管理经验
最低要求
Required:
M.D., Ph.D., D.V.M., M.S., and/or PharmD or equivalent qualifications.
Knowledge and experience in Good Clinical Practices (GCP).
Experience in conduct and execution of clinical trials, including operational feasibility, recruitment, investigator performance and site relations.
Ability to translate innovative approaches into action focused on trial execution and site performance.
工作职责
Clinical Trials:
Co-chairs clinical study team and works collaboratively with other study team members.
Point of accountability to the BU for design, conduct, interpretation and reporting of one or more clinical studies (or elements of those studies).
Provides clinical and scientific expertise to the clinical trial strategy and protocol development process, including acquisition of knowledge of competitor products.
Through application of Enhanced Clinical Trial Design (ECTD) / Enhanced Quantitative Drug Development (EQDD), ensures the most efficient clinical protocols are developed.
Designs/writes clinical trial outlines, protocols and amendments, in collaboration with internal contributors (e.g. statisticians, Outcomes Research (OR) specialists, clinical pharmacologists, clinical project managers, Regional Clinical Site Leads (RCSLs), market access colleagues, commercial development colleagues), internal experts (e.g. clinical program lead, global clinical lead, global clinical strategy lead), and external experts (e.g. investigators, key opinion leaders, advisory board members); ensures design is consistent with objectives.
Proactively authors efficient protocols that minimize the likelihood of amendments.
Identifies and assesses study risks to Good Clinical Practices, subject rights/safety and data integrity throughout protocol development and study conduct; creates, implements and assesses effectiveness of mitigation plans.
Provides clinical input to the Study Team for monitoring guidelines, iqRAMP, statistical analysis plans, informed consent documents, clinical review forms, data edit checks, data quality planning, and Regional Medical Monitor – Medical Oversight Plan as needed; ultimately oversees work of the Study Team.
Contributes to CRO / vendor selection to ensure studies are conducted consistent with protocol requirements, clinical plan expectations and study timelines, including ensuring medical/technical requirements for data integrity (e.g. lab specifications).
Approves selection of countries, clinical sites and investigators with appropriate qualifications, patient populations and recruitment strategy to meet study goals in a timely, high-quality and cost-effective manner.
Ensures studies are registered on [www.clinicaltrials.gov](https://www.clinicaltrials.gov/), study details are kept up to date and basic results are disclosed as required.
Creates (and where appropriate, delivers) clinical/protocol training materials for study and site management, site initiation visits and investigator meetings.
Helps establish and oversees Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
Jointly accountable with the study team for study enrollment and adherence to agreed timelines for study deliverables.
Maintains direct contact with investigative sites through site visits, telephone contacts and email to facilitate investigator engagement, address protocol or investigational product questions and support enrollment activities; works in conjunction with RCSLs when assigned.
Consistent with the Safety Review Plan (SRP), performs and documents regular review of individual subject safety data and cumulative safety data with the safety risk lead; all safety review is performed in consultation with a medically qualified Medical Monitor.
Identifies emerging safety trends and escalates for further discussion with the Clinical Program Lead and/or Global Clinical Lead; follows up with investigators for specific safety findings (e.g. SAEs).
Reviews and manages protocol deviations.
Works with the study team to ensure high quality of data during study conduct (e.g. appropriate patient population, adequacy of clinical assessments).
Conducts clinical review and interpretation of efficacy and safety data, including delivery of top-line reports with statisticians and clinical study reports with medical writers; accountable for quality and timeliness of analysis and reporting.
Responsible for the clinical and scientific validity of study reports, especially conclusions regarding efficacy and safety, and for appropriate disclosure of safety and efficacy data.
Ensures narrative strategy for clinical trials is consistent with program narrative strategy; writes or oversees writing of safety narratives.
Assists in ensuring regulatory compliance for clinical trials and reporting; contributes to primary publication of clinical trial results.
Acts as primary contact with external investigators and internal study teams for clinical/medical protocol questions as needed.
Keeps the Development China Clinical Program Lead and/or Category Development Lead informed of critical issues related to benefit-risk evaluation or study delivery (budget, timelines, quality).
Presents to internal and external advisory committees on clinical trial design and data.
Site Liaison Responsibilities:
Serves as clinical site liaison, supporting trial conduct through virtual meetings, teleconferences and face-to-face contact; maintains the “Face of Pfizer” at sites.
Builds and maintains positive relationships with site staff and key stakeholders.
Ensures site staff understand protocol requirements (technical and logistic); partners with site staff and study teams to overcome feasibility and operational barriers.
Conducts frank discussions, sets clear expectations and monitors site performance through metrics.
Identifies quality issues and escalates protocol-related issues to appropriate medical leads and operational issues to operations team members.
Provides coaching, training and best-practice sharing to site staff.
General:
Motivates and engages colleagues in understanding disease areas, indications and mechanisms of action.
Coaches and mentors less experienced clinicians; may directly manage clinicians.
Maintains and enhances knowledge in relevant disease and technical areas, practice guidelines and regional clinical trial requirements.
Interfaces with other Pfizer sites, business units and functions to share best practices.
Organizes expert panels, consultant or advisory board meetings as needed.
Provides clinical support for Scientific and Commercialization Support (SCS), approved medicines, co-promotions, product defense and epidemiology / OR studies.
Assists in development of publications, abstracts and presentations.
Leads or supports preparation of clinical content for regulatory submissions (e.g. NDA, MAA, IND, sNDA, IB, AR).
Supports discussions with regulators and resolution of regulatory or ethics committee queries.
Ensures compliance with global and local training requirements and clinical/medical controlled documents (CMCDs).
Contributes to continuous improvement activities and clinical staff training.
优先资格
Preferred:
Postgraduate training, certification or fellowship in a medical discipline or drug development is preferred.
Demonstrated scientific productivity (e.g. doctoral thesis, publications, research reports).
Thorough understanding of local and international regulations applicable to clinical trials (pre- and post-approval).
Practical experience in clinical trial strategies, methods and processes.
Track record of design, oversight and interpretation of clinical studies.
Previous leadership or management experience or training.
AI 洞察
优缺点分析
优点
- 身处全球顶尖制药公司，能够接触前沿的药物研发项目和国际化的工作标准
- 职位专业性强，能深度参与新药从开发到上市的关键环节，职业成就感和专业价值高
- 拥有广泛的学习机会，涵盖临床、法规、运营等多个维度，有助于构建复合型专业能力
- 需要持续跟踪并理解不断更新的国际和本地法规、指南，对学习能力要求高
- 作为项目核心成员，对研究质量、时间线和受试者安全负有直接责任，责任重大
- 拥有医学或药学高级学位、具备临床试验实战经验、追求在跨国药企内从事高标准临床研发工作、并具备较强领导力和沟通协调能力的专业人士
缺点 / 挑战
- 临床试验周期长、环节多，需要处理大量复杂的技术和操作问题，工作压力和项目管理挑战大
角色解读
- 在临床研究领域内深耕，成为特定疾病治疗领域的专家或项目负责人
- 可向临床项目管理、临床医学总监或研发管理层（如中国临床项目负责人）方向发展
- 凭借丰富的临床经验和行业网络，也有机会转向医学事务、药物警戒或学术研究等高级职位
- 领导和执行一项或多项临床试验的全流程，确保从方案设计到数据报告的科学性和合规性
- 作为临床站点与公司内部团队的核心联络人，维护研究关系，解决操作难题，监控试验进度和质量
- 参与临床策略制定、法规提交、学术发表以及对初级临床医生的指导和培训
- 深厚的临床医学、药学或生命科学博士级教育背景，以及GCP和临床试验法规的扎实知识
- 卓越的临床试验设计、执行、数据解读和报告撰写能力，能够独立负责复杂的项目
- 出色的跨部门协作、沟通协调和问题解决能力，能够管理与研究者、CRO及内部多方的关系
申请策略
- 仔细研究辉瑞在目标治疗领域的在研管线，思考自己的专业经验如何与之契合，并在面试中展现对疾病的深入理解
- 准备好阐述你处理过的具体挑战，例如如何解决入组困难、处理方案偏离或协调复杂的站点问题
- 突出博士学位及任何博士后、专科培训经历，强调在特定疾病领域的科研产出（论文、专利等）
- 详细列举参与或主导的临床试验项目（I-IV期均可），明确自己在其中的具体职责和贡献（如方案设计、站点管理、数据分析）
- 强调对GCP、ICH指南及中国临床试验法规的理解和应用经验，以及与研究者、CRO、监管机构沟通的成功案例
- 展示项目管理能力，包括如何协调跨职能团队、控制风险、确保数据质量和项目按时交付
- 强化对Enhanced Clinical Trial Design (ECTD) 和 Enhanced Quantitative Drug Development (EQDD) 等先进设计方法的理解
- 提升数据统计分析解读能力，以便更高效地与统计学家和医学作家协作
面试指南
- 使用STAR法则（情境-任务-行动-结果）来组织你的回答，清晰展示你在具体情境下的思考、行动和最终取得的量化或质化成果
- 在回答时，始终将你的经验与辉瑞的职位要求联系起来，表明你理解这个职位的核心职责（如站点管理、方案设计、团队协作）
- 对于技术性问题，展现你对细节的关注和对法规、GCP原则的熟稔，而不仅仅是泛泛而谈
- 请描述一个你从头到尾负责的临床试验项目，你面临的主要挑战以及你是如何解决的？
- 你如何确保临床试验的方案设计既科学严谨又具可操作性，以最小化方案修改的可能性？
- 当研究者对方案条款有异议或站点执行遇到重大障碍时，你的沟通策略和解决步骤是什么？
- 你如何监督和评估临床站点的绩效？请举例说明你识别并解决了一个数据质量或合规性问题
- 你对中国以及国际上用于临床试验的关键法规（如GCP、ICH、NMPA指南）有何理解？
职位点评
薪资福利70
成长发展90
工作生活55
使命价值85
薪资福利
70中等
作为跨国药企的高级专业职位，通常能提供具有市场竞争力的薪酬福利体系，但具体水平未在JD中披露。
薪资信号未披露（AI估算：3千–5万/月）
成长发展
90较高
该职位位于药物研发的核心环节，能接触前沿临床开发理念（如ECTD/EQDD），并承担高度复杂的项目职责，对专业技能和职业视野的提升有极大帮助。
技术前沿前沿/新兴技术
技术栈Enhanced Clinical Trial Design (ECTD)、Enhanced Quantitative Drug Development (EQDD)、GCP、临床试验设计
成长机会Coaches and mentors less experienced clinicians、Maintains and enhances knowledge in relevant disease and technical areas、Contributes to continuous improvement activities and clinical staff training
业务类型profit_center
工作生活
55较低
职位性质要求与研究站点密切沟通和现场监查，大概率需要频繁出差或前往研究中心，工作强度和时间灵活性可能面临挑战。
工作模式未明确
办公地点未明确
加班情况未提及（无法判断）
使命价值
85较高
参与新药临床试验直接关系到患者治疗和健康改善，具有明确的社会价值。所在行业为高速增长的生物医药赛道，创新性强。
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Motivates and engages colleagues in understanding disease areas, indications and mechanisms of action
创新程度积极采用新技术
辉瑞 的其他在招职位
相似职位推荐
Watch Jobs