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无工作经验 -
博士 -
招2人 -
11-09 发布
- 五险一金
- 通讯补贴
- 专业培训
- 年终奖金
- 定期体检
职位描述
职位描述： 工作职责：?Position Purpose:oResponsible for designing and implementing a Clinical Pharmacology plan that conforms to appropriate regulatory guidelines such that rational development and registration of drug candidates can be rapidly achieved in China.oServes as the Clinical Pharmacology representative on drug development and clinical sub-teams and provides clinical pharmacology expertise and leadership to projects.oPlans and directs clinical pharmacology components of clinical programs (including clinical development plan) and studies (including design, clinical phase oversight, synopsis preparation and reporting).oLeads multifunctional study team to design, deliver and report the assigned clinical pharmacology studies and has overall scientific accountability for the designated studies.oResponsible (with Clinicians and Statisticians) for ensuring appropriate dose-finding strategies during clinical drug development that will ensure optimal doses and dosage regimens in patients.oAccountable for the development and implementation of a clinical modeling and simulation plan based on agreed upon best practices (i.e. model-based drug development) in collaboration with Pharmacometrics.oResponsible for use of quantitative methods to integrate knowledge of pharmacokinetics (PK), pharmacodynamics (PD), patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development.oResponsible for appropriate summarization and interpretation of results of PK-PD analyses with respect to their impact on development and clinical use of drugs.oIn collaboration with global Business Unit, evaluates PK (and/or PD) and safety results among ethnic groups to contribute to the faster submission and authorization in China utilizing global study results.oProvides clinical pharmacology support and leadership in the preparation and defense of regulatory submissions.Organizational Relationships:oSolid line report within the line organization of Development China.oCollaborates closely with project team members, particularly with other triad colleagues from Clinical Development, Statistics and Pharmacometricians.oProvides matrix leadership to a wider Clinical Pharmacology team (e.g. from Global Clinical Pharmacology including US/EU Clinical Pharmacology Leads, Pharmacometrics, Clinical Assay Group), particularly for larger projects.oOther important partnerships can include Development Operations, Pharmacokinetics, Dynamics and Metabolism (PDM), Drug Safety R&D, Pharmaceutical Sciences, Global Medical Affairs, Market Access and Commercial Development.Resources Managed (budget and FTEs):oResponsible for designing cost efficient studies and clinical pharmacology programs.Primary Duties:oClinical Pharmacology representative on clinical sub-team and development team as appropriate.oResponsible for providing the clinical pharmacology components of the clinical development plan and provides clinical pharmacology expertise to the project team with close supervision.oHas a cursory understanding of the overall clinical development plan and works closely with the clinical sub-team and development team to continually update and refine the plan.oWith Clinical Lead, assures that assigned clinical pharmacology studies fulfill their role in the overall development plan.oPlans, designs and oversees clinical pharmacology studies as required with operational assistance from DC Development Operations. Accountable and responsible for assigned synopsis and study report content with close supervision.oWith study team, tracks emerging clinical pharmacology profile of the drug, keeps line management informed of changes in the profile as they occur in the assigned studies. Must be fully knowledgeable about the clinical pharmacology profile of allocated drugs for which studies are being conducted or which are called for in the protocol (e.g. interacting drug).oCoordinates with medical writers (and other team members) in the data review, analysis and reporting of clinical pharmacology studies. Is responsible, in conjunction with medical writer, for overall content and accuracy of study report before forwarding for final sign-off with close supervision. Assists with internal and external dissemination of results to Development Team, Investigators etc.oIs a coach and mentor for the clinical study team for the specifics of clinical pharmacology protocols in which it is being conducted.oAccountable for non-compartmental analysis of PK data and for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, meta-analysis etc. Using tools such as NONMEM and R. Directs the planning of all relevant PK-PD analyses.oResponsible for use of quantitative methods to integrate knowledge of PK, PD, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development in collaboration with Pharmacometrics and Statistics with close supervision.oProvides recommendations for clinical doses and dosing algorithms (including drug interaction advice, advice for concomitant administration with food, special population dosing, development of novel formulations, biosimilars and generics etc.) to the clinical sub-team and development team and in regulatory documentation such as labeling with close supervision.oLeads clinical pharmacology contributions to all regulatory documents including Investigator’sBrochures, CTA and NDA dossier with close supervision. Leads the resolution of clinical pharmacology queries from drug regulatory agencies and takes a lead role in writing and reviewing responses to regulatory queries with close supervision.oStays abreast of literature, government guidelines, and internal guidance on clinical trial conduct, including internal SOPs, and regulations for specific projects to which assigned in order to be a team resource of clinical pharmacology knowledge in terms of both medical background and clinical trial design.oEnsures that appropriate subject matter expertise is provided to address regulatory agency queries and interactions with close supervision.oContributes to regulatory strategy and is prepared to provide regulatory defense of the proposed label with close supervision.oAble to present quality scientific work at external meetings and publish the scientific work. With line management endorsement, manage and initiate external collaborations with world leading clinical pharmacology experts to develop new methodologies.任职资格：Qualifications and Attributes:oEducational: Pharm. D., Ph.D., or equivalent training or experience in pharmacokinetics, pharmacometrics, clinical pharmacology or related discipline.Technical Competencies:oClinical pharmacology: demonstrates cursory understanding of the following: 1) principles of PK, PK-PD and pharmacology relevant to drug candidates; 2) other relevant scientific disciplines, including drug metabolism, drug transport, formulation sciences, biopharmaceutics, pathophysiology and therapeutics; and 3) quantitative modeling and simulation principlesoCommunication skills: Demonstrates ability to effectively present PK/PD data, clinical pharmacology development plans and strategies to various audiences in both verbal and written form (English and Mandarin); demonstrate ability to write PK/PD results, interpretations (including impact) and conclusions for clinical study reports and regulatory documents that are clear and concise.oRegulatory knowledge: Understands and is able to apply appropriate China FDA, US FDA, EMA and ICH guidelines in the design of clinical development plans and studies with close supervision. 职能类别： 医药技术研发管理人员
联系方式
北大街3-7号五矿广场（2号线东四十条地铁口旁）
公司信息
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，是目前全球最大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“ ”。我们的使命是“ ”。 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.
