南平招聘

工作职责:

? Leads China clinical development strategy and delivery, as part of global development.

? Ensures that clinical trials for their program are designed and executed to the highest scientific and quality standards, and are focused on addressing the relevant technical and/or business objectives.

? Accountable for negotiating milestones and ensuring delivery of clinical trials in line with agreed timelines.

? Identifies and assesses program risks; creates, implements and assesses effectiveness of mitigation plans.

? As delegated by the Head of China Clinical Development, may lead development of and adherence to Safety Review Plan (SRP). Consistent with SRP, performs and documents regular review of individual subject safety data and cumulative safety data with the safety risk 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 Head of China Clinical Development and/or medical monitor as appropriate.

? In collaboration with Head of China Clinical Development and China Clinical Development colleagues, contributes to clinical preparation for and attends meetings with regulatory agencies and the resolution of clinical queries from drug regulatory agencies.

? Maintains disease area knowledge relevant to their program, in particular with regards to design and outcome of clinical trials for competitors. This may include responsibilities for clinical expert panel meetings and advisory boards to give input on clinical plans.

? Responsible for operational excellence and timely production and approval of quality clinical deliverables for their program, including protocols, study reports, contributions to the clinical plan and regulatory submissions/documents (e.g. NDA, MAA, IND, sNDA, IB, AR), and manu"script"s intended for external publication. The China Clinical Program Lead provides final sign off for documents generated by Study Clinician(s) when supervising their activities.

? Through effective collaboration with colleagues in relevant Global Clinical function, ensures appropriate medical and scientific expertise from different countries and regions is consistently brought to all clinical program strategy, design, execution and interpretation activities.

? Involves internal experts and consults with relevant technical advisory committee(s) to ensure high quality protocol designs and efficient clinical development plans that reflect Enhanced Clinical Trial Design (ECTD)/ Enhanced Quantitative Drug Development (EQDD) principles, current disease area knowledge, and incorporation of all relevant elements of the Understand and Deliver decision-making framework for their program.

? Provides clinical leadership on Phase 3b/4 programs regarding Scientific and Commercialization Support (SCS), co-promotion, product defense and clinical consultation on Epidemiology and Outcomes Research studies.

? Maintains a productive, collaborative relationship with a broad group of internal stakeholders (e.g. Medical, Statistics, Clinical Pharmacology, Portfolio and Project Management, Clinical Trial Management, Pharmaceutical Sciences, Safety, Regulatory etc.).

? Plans resources required for elements of program under his/her responsibility, in order to accomplish the clinical objectives in a timely and resource-efficient fashion.

? Responsible for the development, retention and engagement of clinical colleagues reporting to them.

? Ensures technical excellence and functional competency of Study Clinicians who report to them, through oversight, coaching, mentoring, performance management and training.

? Keeps Head of China Clinical Development informed of clinical progress and any critical clinical issues, especially those impacting the emerging benefit:risk profile.

? May support technical review of licensing opportunities, including due diligence activities.

? Ensures compliance with global and local training requirements and adherence to relevant global / local clinical and medical controlled documents (CMCDs) assigned to them and to the clinical colleagues reporting to them.

? May present to senior management, governance committees and external audiences on the clinical aspects of compound development, including milestones, strategies and data, as appropriate.

? Contributes to (or leads) continuous improvement activities, and to education and training of clinical staff in areas of competence/experience.

? Demonstrated clinical/medical, administrative, and project management capabilities, as well as effective verbal and written communication skills in relating to individuals both inside and outside Pfizer.

? Track record of achievement in clinical development, with a preference for exposure in disease area of relevance; able to independently formulate and execute clinical development or lifecycle strategy.

? Demonstrated potential or ability to design, initiate and conduct clinical studies as part of an integrated clinical plan.

? Able 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.

? Proven scientific writing skills, with strong interpersonal, written/verbal communication skills, including ability to evaluate, interpret and present complex data.

? Able to set priorities and manage cross-functional teams and complex projects to deliver milestones according to set budgets; sets priorities; able to define and manage appropriate resource requirements (budgets and FTEs) both in-house and vendors / contractors.

? 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

? 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.

任职资格:

Education

? Required: M.D., Ph.D., D.V.M., M.S., and/or PharmD or equivalent qualifications.

? Preferred: Postgraduate training/certification /fellowship in a medical discipline or in drug development. Demonstrated scientific productivity (e.g. doctoral thesis, publications, research reports, etc.).

Experience

? Required: Proven track record of being a successful Study Clinician (preferably in late phase development, or post-approval, as applicable to role).

? Preferred: Thorough understanding of local / international regulations applicable to clinical trials (pre and post approval). Experience in pharmaceutical industry as people manager of clinical colleagues.

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.