Clinician
辉瑞制药有限公司
- 公司规模：5000-10000人
- 公司性质：外资(欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2017-04-25
- 工作地点：北京-东城区
- 招聘人数：若干人
- 学历要求：本科
- 职位月薪：4.5-6千/月
- 职位类别：生物工程/生物制药
职位描述
职位描述：
工作职责
Role Summary:
The Development China Clinician is responsible for high quality and timely delivery of one or more interventional clinical trials for a Global Product Development /Pfizer Essential Health (PEH). They apply technical excellence in the design of cost-efficient clinical trials to meet the needs of internal and external customers, ensure effective conduct and medical/scientific oversight of studies (in partnership with Development Operations) and support appropriate interpretation and communication of clinical trial data (including high quality regulatory submissions and product defense activities). They ensure compliance with internal and external standards, proactively mitigate risk and manage emerging clinical issues.
The China Clinician may act as a site liaison and point of contact to expedite study start-up and conduct and to support clinical training, compliance and overall study quality.
Organizational Relationships:
Reports to Development China Clinical Program Lead
Resources Managed (budget and FTEs):
Depending on the program, the Development China Clinician may manage a group of 1 to 5 Development China Clinicians.
Responsibilities:
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.
Proactive in authoring 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 Study Team for monitoring guidelines, iqRAMP, statistical analysis plans, informed consent documents, clinical review forms, data edit checks, data quality planning, Regional Medical Monitor - Medical Oversight Plan as needed (ultimately oversees work of Study Team).
Contributes to CRO / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied (e.g. lab specifications).
Approves selection of countries, clinical sites and investigators with appropriate qualifications, patient populations, and recruitment strategy to meet goals in a timely, high quality and cost effective manner.
Ensures study is registered on 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 and for use during 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 study team for study enrollment and adherence to agreed timelines for study deliverables.
Maintains direct contact with investigative sites through site visits, telephone contacts, email etc., in order to facilitate investigator engagement, address investigator questions regarding the protocol or the investigational product, and support enrolment activities. This is done in conjunction with RCSLs (when assigned) for sites outside US, Canada, Japan and China. For some studies the clinician may take on an expanded role as described below for the site liaison responsibilities.
Consistent with Safety Review Plan (SRP), performs and documents regular review of individual subject safety data and cumulative safety data with the safety risk lead (as delegated by the China Clinical Program Lead or the Global Clinical Lead). For all studies, clinical safety review should be performed in consultation with a designated medically-qualified Medical Monitor.
Responsible for identifying emerging safety trends and raising them forward 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 study team to ensure high quality of data, e.g. appropriate patient population, adequacy of clinical assessments etc., as study is ongoing.
Conducts clinical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer; accountable for overall quality and timeliness of analysis and reporting.
Responsible for clinical and scientific validity of study report, especially conclusions regarding efficacy and safety. Responsible for disclosure of appropriate safety and efficacy data and conclusions.
Ensures narrative strategy for clinical trial(s) 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.
May act as primary contact with external investigators and internal study team for questions relating to the clinical/medical aspects of the protocol.
Responsible for keeping the Development China Clinical Program Lead and/or Global Clinical Lead informed of any critical issues relating to benefit:risk evaluation, or study delivery in line with agreed budget, timelines and quality.
Presents to internal and external advisory committees (e.g. Technical Review Committee, advisory boards) on design of clinical trials and data from clinical trials.
Site Liaison Responsibilities (if applicable)
The China Clinician may have site liaison responsibilities:
Serve as clinical site liaison to support trial conduct through virtual meetings or teleconferences (as appropriate) and essential face-to-face contact, working directly with site staff. Maintain the ‘Face of Pfizer’ at each site. Create and maintain positive relationships and enthusiasm.
Understand the work environment and key relationships at clinical sites, use analytical and influencing skills to improve communications and collaboration between key stakeholders.
Ensure site staff have thorough understanding of protocol requirements (technical and logistic), partner with site staff and study team members to overcome feasibility barriers and operational obstacles and ensure successful subject recruitment/enrollment/retention, protocol compliance and clinical trial quality.
.
Conduct frank discussions and set clear expectations for site performance and monitor site performance through metrics.
Identify quality issues and discuss with Pfizer clinical/operations study team members so that corrective actions may be instituted. Escalate protocol-related issues requiring medical expertise to the RCSL or medically-qualified China Clinical Program Lead, if needed. Escalate operational issues to the appropriate operations study team member.
Identify the need for and provide supportive coaching and/or training to site staff, as appropriate.
Identify methods, techniques, key relationships and logistic approaches employed by most successful sites and translate/transfer these best practices to aspiring sites.
General
Motivates and engages colleagues in an understanding of disease and commitment and excitement to an indication and mechanism.
Coaches and mentors less experienced clinicians; may directly manage clinicians.
Maintains and enhances knowledge in relevant disease area and/or technical area (e.g. pediatrics, regional clinical trials) and practice guidelines relevant to the regions in which clinical trials are being conducted.
Interfaces with other Pfizer sites, other BUs and other functions to develop and share best practices, as appropriate.
May organize expert panel, consultant or advisory board meetings to provide input to protocols, clinical plans or data analysis.
Provides clinical assistance regarding Scientific and Commercialization Support (SCS) for approved medicines, co-promotions, product defense, and clinical consultation on epidemiology and OR studies.
Assists in the development of publications, abstracts, and/or presentations.
Leads or assists in the preparations of the clinical content of regulatory submissions/documents (e.g. NDA, MAA, IND, sNDA, IB, AR).
Assists in discussions with regulators and with the resolution of queries from drug regulatory agencies / ethics committees; leads or contributes to writing and review responses to regulatory queries.
May support technical review of licensing opportunities, including due diligence activities.
任职资格
Technical / Behavioral Competencies:
? Demonstrated potential or ability to design, initiate and conduct clinical studies in industry, academic, or research clinic setting.
? Proven scientific writing skills, with strong interpersonal, written/verbal communication skills, including ability to evaluate, interpret and present complex data.
? Ability to review and understand the emerging safety and efficacy profile of the drug candidate; part of this skill is putting the profile in perspective with comparator agents.
? Able to present complex, technical ideas and concepts, both verbally and in writing, in such a way that they are understood by colleagues and stakeholders at all levels and/or from other disciplines.
? Collaborative problem solving (handles conflict constructively).
? Creativity and/or ability to put innovative approaches into practice in clinical development.
? Able to embody Pfizer leader behaviors and the OWN-IT culture.
? Able to anticipate issues related to operational feasibility, recruitment challenges, able to discuss investigator performance issues, coach and/or mentor clinical investigative site staff to achieve operational and recruitment goals and quality standards.
? Able to place innovative approaches into action that focus on trial execution and site performance.
Qualifications (Training, Education & Prior Experience):
Education
? Required: BA/BS or equivalent qualification.
? Preferred: M.D., Ph.D., D.V.M., M.S., and/or PharmD. or equivalent qualifications. Postgraduate training/certification /fellowship in a medical discipline or in drug development. Demonstrated scientific productivity (e.g. doctoral thesis, publications, research reports, etc.).
Experience
? Preferred: Thorough understanding of local / 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 / management experience or training.
? Required: Knowledge and experience in Good Clinical Practices. Experience in conduct and execution of clinical trials, including operational feasibility, recruitment, investigator performance, investigative site relations.
举报
分享
工作职责
Role Summary:
The Development China Clinician is responsible for high quality and timely delivery of one or more interventional clinical trials for a Global Product Development /Pfizer Essential Health (PEH). They apply technical excellence in the design of cost-efficient clinical trials to meet the needs of internal and external customers, ensure effective conduct and medical/scientific oversight of studies (in partnership with Development Operations) and support appropriate interpretation and communication of clinical trial data (including high quality regulatory submissions and product defense activities). They ensure compliance with internal and external standards, proactively mitigate risk and manage emerging clinical issues.
The China Clinician may act as a site liaison and point of contact to expedite study start-up and conduct and to support clinical training, compliance and overall study quality.
Organizational Relationships:
Reports to Development China Clinical Program Lead
Resources Managed (budget and FTEs):
Depending on the program, the Development China Clinician may manage a group of 1 to 5 Development China Clinicians.
Responsibilities:
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.
Proactive in authoring 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 Study Team for monitoring guidelines, iqRAMP, statistical analysis plans, informed consent documents, clinical review forms, data edit checks, data quality planning, Regional Medical Monitor - Medical Oversight Plan as needed (ultimately oversees work of Study Team).
Contributes to CRO / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied (e.g. lab specifications).
Approves selection of countries, clinical sites and investigators with appropriate qualifications, patient populations, and recruitment strategy to meet goals in a timely, high quality and cost effective manner.
Ensures study is registered on 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 and for use during 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 study team for study enrollment and adherence to agreed timelines for study deliverables.
Maintains direct contact with investigative sites through site visits, telephone contacts, email etc., in order to facilitate investigator engagement, address investigator questions regarding the protocol or the investigational product, and support enrolment activities. This is done in conjunction with RCSLs (when assigned) for sites outside US, Canada, Japan and China. For some studies the clinician may take on an expanded role as described below for the site liaison responsibilities.
Consistent with Safety Review Plan (SRP), performs and documents regular review of individual subject safety data and cumulative safety data with the safety risk lead (as delegated by the China Clinical Program Lead or the Global Clinical Lead). For all studies, clinical safety review should be performed in consultation with a designated medically-qualified Medical Monitor.
Responsible for identifying emerging safety trends and raising them forward 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 study team to ensure high quality of data, e.g. appropriate patient population, adequacy of clinical assessments etc., as study is ongoing.
Conducts clinical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer; accountable for overall quality and timeliness of analysis and reporting.
Responsible for clinical and scientific validity of study report, especially conclusions regarding efficacy and safety. Responsible for disclosure of appropriate safety and efficacy data and conclusions.
Ensures narrative strategy for clinical trial(s) 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.
May act as primary contact with external investigators and internal study team for questions relating to the clinical/medical aspects of the protocol.
Responsible for keeping the Development China Clinical Program Lead and/or Global Clinical Lead informed of any critical issues relating to benefit:risk evaluation, or study delivery in line with agreed budget, timelines and quality.
Presents to internal and external advisory committees (e.g. Technical Review Committee, advisory boards) on design of clinical trials and data from clinical trials.
Site Liaison Responsibilities (if applicable)
The China Clinician may have site liaison responsibilities:
Serve as clinical site liaison to support trial conduct through virtual meetings or teleconferences (as appropriate) and essential face-to-face contact, working directly with site staff. Maintain the ‘Face of Pfizer’ at each site. Create and maintain positive relationships and enthusiasm.
Understand the work environment and key relationships at clinical sites, use analytical and influencing skills to improve communications and collaboration between key stakeholders.
Ensure site staff have thorough understanding of protocol requirements (technical and logistic), partner with site staff and study team members to overcome feasibility barriers and operational obstacles and ensure successful subject recruitment/enrollment/retention, protocol compliance and clinical trial quality.
.
Conduct frank discussions and set clear expectations for site performance and monitor site performance through metrics.
Identify quality issues and discuss with Pfizer clinical/operations study team members so that corrective actions may be instituted. Escalate protocol-related issues requiring medical expertise to the RCSL or medically-qualified China Clinical Program Lead, if needed. Escalate operational issues to the appropriate operations study team member.
Identify the need for and provide supportive coaching and/or training to site staff, as appropriate.
Identify methods, techniques, key relationships and logistic approaches employed by most successful sites and translate/transfer these best practices to aspiring sites.
General
Motivates and engages colleagues in an understanding of disease and commitment and excitement to an indication and mechanism.
Coaches and mentors less experienced clinicians; may directly manage clinicians.
Maintains and enhances knowledge in relevant disease area and/or technical area (e.g. pediatrics, regional clinical trials) and practice guidelines relevant to the regions in which clinical trials are being conducted.
Interfaces with other Pfizer sites, other BUs and other functions to develop and share best practices, as appropriate.
May organize expert panel, consultant or advisory board meetings to provide input to protocols, clinical plans or data analysis.
Provides clinical assistance regarding Scientific and Commercialization Support (SCS) for approved medicines, co-promotions, product defense, and clinical consultation on epidemiology and OR studies.
Assists in the development of publications, abstracts, and/or presentations.
Leads or assists in the preparations of the clinical content of regulatory submissions/documents (e.g. NDA, MAA, IND, sNDA, IB, AR).
Assists in discussions with regulators and with the resolution of queries from drug regulatory agencies / ethics committees; leads or contributes to writing and review responses to regulatory queries.
May support technical review of licensing opportunities, including due diligence activities.
任职资格
Technical / Behavioral Competencies:
? Demonstrated potential or ability to design, initiate and conduct clinical studies in industry, academic, or research clinic setting.
? Proven scientific writing skills, with strong interpersonal, written/verbal communication skills, including ability to evaluate, interpret and present complex data.
? Ability to review and understand the emerging safety and efficacy profile of the drug candidate; part of this skill is putting the profile in perspective with comparator agents.
? Able to present complex, technical ideas and concepts, both verbally and in writing, in such a way that they are understood by colleagues and stakeholders at all levels and/or from other disciplines.
? Collaborative problem solving (handles conflict constructively).
? Creativity and/or ability to put innovative approaches into practice in clinical development.
? Able to embody Pfizer leader behaviors and the OWN-IT culture.
? Able to anticipate issues related to operational feasibility, recruitment challenges, able to discuss investigator performance issues, coach and/or mentor clinical investigative site staff to achieve operational and recruitment goals and quality standards.
? Able to place innovative approaches into action that focus on trial execution and site performance.
Qualifications (Training, Education & Prior Experience):
Education
? Required: BA/BS or equivalent qualification.
? Preferred: M.D., Ph.D., D.V.M., M.S., and/or PharmD. or equivalent qualifications. Postgraduate training/certification /fellowship in a medical discipline or in drug development. Demonstrated scientific productivity (e.g. doctoral thesis, publications, research reports, etc.).
Experience
? Preferred: Thorough understanding of local / 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 / management experience or training.
? Required: Knowledge and experience in Good Clinical Practices. Experience in conduct and execution of clinical trials, including operational feasibility, recruitment, investigator performance, investigative site relations.
职能类别： 生物工程/生物制药
公司介绍
辉瑞公司（Pfizer Inc.）创建于1849年，迄今已有160多年的历史，总部位于美国纽约，是目前全球***的以研发为基础的生物制药公司。辉瑞致力于运用创新的科学技术以及全球资源来改善每个生命阶段的健康和福祉。
我们的目标是“不断创新为患者带来能显著改善其健康的药物”。我们的使命是“成为一家卓越的创新型生物制药公司”。
2012年辉瑞公司全年合计收入590亿美元，研发投入78亿美元。辉瑞在全球拥有9万多名员工，59家生产基地，业务遍及全球150多个国家和地区。2012年财富全球500强企业中辉瑞排名126位。
目前辉瑞公司的产品覆盖了包括化学药物、生物制剂、疫苗、健康药物、动物保健品等用于人类、动物和消费者保健等诸多广泛而极具潜力的治疗及健康领域，同时其卓越的研发和生产能力处于全球领先地位。
在人类和动物药品的发现、开发和生产过程中，辉瑞始终致力于奉行严格的质量、安全和价值标准。每天，分布在世界各地的辉瑞员工致力于促进当地医疗卫生的发展以及探索能够应对当今最为棘手疾病的预防和治疗方案。
辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作，支持世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。160多年来，辉瑞一直努力为人们提供更好、更优质的服务。
辉瑞生物制药目前在华上市的创新药物已超过50个，其治疗领域涵盖了心脑血管及代谢、抗感染、中枢神经、抗炎镇痛、抗肿瘤、泌尿、疫苗及等诸多领域。其中如立普妥®、络活喜®、万艾可®、舒普深®、希舒美®、沛儿®、索坦®许多产品在市场上处于领先地位。为了让中国的广大患者能及时接受与全球同步的先进的药物治疗，辉瑞未来将进一步加大和加快在华新药引进和上市的力度和速度。
辉瑞健康药物旗下的善存®、钙尔奇®、惠菲宁®等消费保健产品也在中国市场家喻户晓，并以其优异的品质深受广大消费者的青睐；辉瑞旗下的硕腾动物保健品*为中国的动物保健市场提供各类领先的动物疫苗和动物药品。
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products of healthcare industry and many of the world's best-known healthcare products such as Centrum. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 160 years, Pfizer has worked to make a difference for all who rely on us.
我们的目标是“不断创新为患者带来能显著改善其健康的药物”。我们的使命是“成为一家卓越的创新型生物制药公司”。
2012年辉瑞公司全年合计收入590亿美元，研发投入78亿美元。辉瑞在全球拥有9万多名员工，59家生产基地，业务遍及全球150多个国家和地区。2012年财富全球500强企业中辉瑞排名126位。
目前辉瑞公司的产品覆盖了包括化学药物、生物制剂、疫苗、健康药物、动物保健品等用于人类、动物和消费者保健等诸多广泛而极具潜力的治疗及健康领域，同时其卓越的研发和生产能力处于全球领先地位。
在人类和动物药品的发现、开发和生产过程中，辉瑞始终致力于奉行严格的质量、安全和价值标准。每天，分布在世界各地的辉瑞员工致力于促进当地医疗卫生的发展以及探索能够应对当今最为棘手疾病的预防和治疗方案。
辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作，支持世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。160多年来，辉瑞一直努力为人们提供更好、更优质的服务。
辉瑞生物制药目前在华上市的创新药物已超过50个，其治疗领域涵盖了心脑血管及代谢、抗感染、中枢神经、抗炎镇痛、抗肿瘤、泌尿、疫苗及等诸多领域。其中如立普妥®、络活喜®、万艾可®、舒普深®、希舒美®、沛儿®、索坦®许多产品在市场上处于领先地位。为了让中国的广大患者能及时接受与全球同步的先进的药物治疗，辉瑞未来将进一步加大和加快在华新药引进和上市的力度和速度。
辉瑞健康药物旗下的善存®、钙尔奇®、惠菲宁®等消费保健产品也在中国市场家喻户晓，并以其优异的品质深受广大消费者的青睐；辉瑞旗下的硕腾动物保健品*为中国的动物保健市场提供各类领先的动物疫苗和动物药品。
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products of healthcare industry and many of the world's best-known healthcare products such as Centrum. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 160 years, Pfizer has worked to make a difference for all who rely on us.
联系方式
- Email：chinahrwest@Pfizer.com
- 公司地址：南京西路中信泰富