南平招聘

职位描述：
工作职责：
Primary Duties:
? Clinical Pharmacology representative on clinical sub-team and development team as appropriate.
? Responsible for providing the clinical pharmacology components of the clinical development plan and provides clinical pharmacology expertise to the project team.
? Has a thorough 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.
? Assures that assigned clinical pharmacology studies fulfill their role in the overall development plan.
? Plans, designs and oversees clinical pharmacology studies as required with operational assistance from Development Operations. Accountable and responsible for assigned synopsis and study report content.
? With 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).
? Coordinates 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. Assists with internal and external dissemination of results to Development Team, Investigators etc.
? Is a coach and mentor for the clinical study team for the specifics of clinical pharmacology protocols and therapeutic area in which it is being conducted.
? Accountable 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.
? Responsible 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.
? Provides 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.
? Leads clinical pharmacology contributions to all regulatory documents including Investigator’s
Brochures, CTA and NDA dossier. Leads the resolution of clinical pharmacology queries from drug regulatory agencies and takes a lead role in writing and reviewing responses to regulatory queries.
? Stays 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.
? Ensures that appropriate subject matter expertise is provided to address regulatory agency queries and interactions.
? Contributes to regulatory strategy and is prepared to provide regulatory defense of the proposed label.
? May represent group on company initiative sub-teams.
? May participate in multidisciplinary teams in assessing potential in-licensing opportunities, as requested by line management.
? Able 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:
? Educational: Pharm. D., Ph.D., or equivalent training or experience in pharmacokinetics, pharmacometrics, clinical pharmacology or related discipline.
? Considerable organizational awareness (inter-relationship of departments, business priorities, etc.)
? At least 4 years of industrial or relevant experience in clinical pharmacology area.

Technical Competencies

? Clinical pharmacology: demonstrates thorough 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 principles
? Communication skills: Demonstrates ability to effectively present PKPD data, clinical pharmacology development plans and strategies to various audiences in both verbal and written form (English and Mandarin); demonstrate ability to write PKPD results, interpretations (including impact) and conclusions for clinical study reports and regulatory documents that are clear and concise.
? Regulatory 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. 举报 分享

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.