南平招聘

工作职责:

JOB SUMMARY

As a member of the Clinical Assay Group within Development China Clinical Pharmacology, Clinical Assay Lead will play a critical role in supporting clinical strategies in all stages of drug development and post marketing activities through scientific and technical leadership, oversight and management of external and internal partners involved in delivering quality, timely, and regulatory compliant PK, PD, immunogenicity and biomarker analytical assays and data (as relevant to Small Molecule, Biologics or biomarker).

JOB RESPONSIBILITIES

Serves as a member of the clinical study team and analytical subject matter expert for executing clinical study setup & conduct, contributing to the study protocol development & review, preparing submissions, addressing regulatory queries, implementing bioanalytical strategies & assays, and delivering regulatory compliant data and reports within program timelines.

Leads and oversees small or large molecule PK, PD, and immunogenicity (ADA and Nab) assay and biomarker assay lifecycle management from early stage to registration. Analytical strategy execution, method design, development, and validation, as well as data quality review will be involved. Corresponds sample analyses & reports to meet evolving program objectives and regulatory expectations. Assists CROs with effective troubleshooting of the bioanalytical assay and issue resolution.

Functions as key point of contact with external & internal laboratories and supports (or leads, as appropriate) selection, qualification, performance evaluation, and periodic audits of CRO laboratories conducting clinical PK, PD and immunogenicity assays (as relevant to the role).

Supports the clinical trial conduct within scope of the Clinical Assay Group responsibilities, including development and review of documents and processes such as CRF and data setup, clinical site lab manual, sample management & reconciliation, bioanalytical study planning & reporting, budgeting & invoicing, compliance with clinical SOPs & policies, and regulatory inspection readiness & conduct.

Contributes to the development of Best Practices, processes, templates, and policies.

 Maintains up-to-date knowledge of current and novel chromatographic separation/mass spectrometry based detection, ligand binding technologies & techniques or bioanalytical techniques commonly used for Biomarkers (as relevant to the role), global regulatory guidances & expectations, and industry best practices.

任职资格:

Qualifications:BASIC QUALIFICATIONS

？ PhD with 5+ years or M.S. with 8+ years of industry or bioanalytical experience with PK and/or immunogenicity assay and biomarker assay development, validation, and sample analyses usingchromatographic/mass spectrometry, ligand binding (ELISA and ECL) or other methodologies like flowcytometry, FISH and etc. (as relevant to the role).？ Working knowledge of GxP regulations governing conduct of clinical trials and regulatory guidance andexpectations relevant to regulated bioanalysis.？ Subject matter expert in regulated bioanalysis small organic molecules or Biologics and understanding ofbioanalytical techniques commonly used for Biomarkers.？ In depth knowledge of GxP regulations governing conduct of clinical trials and regulatory guidance and expectations relevant to regulated bioanalysis.？ Highly effective communication skills: verbal, written, and presentation.

PREFERRED QUALIFICATIONS (BASED ON THE POSITION LEVEL AND REQUIRED EXPERIENCE)

？ Experience with regulatory inspections.？ Experience preparing regulatory submissions and addressing regulatory queries.？ Understanding of clinical trial design and overall principles of clinical development and related disciplines (e.g., pharmacokinetics and clinical pharmacology, statistics, ADME, formulation and drug product).？ Prior experience with training, mentoring or managing colleagues.As Specific to Small Molecule:？ Hands-on experience with the development, validation and troubleshooting of the methods for LC/MS quantitation, along with experience implementing HPLC/UPLC/GC separation, sample preparation techniques, mass spectrometry detection platforms and their application in clinical sample analysis.？ Experience with human ADME, protein binding, immunocapturing hybrid assays and technologies such as LCAMS and HRMS.As Specific to Biologics:？ Hands-on experience with the development, validation and troubleshooting of the methods for PK and immunogenicity (including the determination of assay cut points, tolerance, and sensitivity along with experience implementing ACE, BEAD, and SPEAD methodologies) and clinical sample analysis.？ Understanding of critical reagent generation & lifecycle management？ Experience with biosimilars, gene therapy, multi-domain therapeutics, immunocapture, protein binding, cell based assays and technologies such as RT-PCR, qPCR, ELISPOT, AMS and FACs.As Specific to Biomarker:？ Hands-on experience with the development, validation and troubleshooting of the methods commonly used for Biomarkers, including but limited to flow cytometry, FISH, IHC and NGS.

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.