(Senior)Manager,Clinical Pharmacology(Bioanalysis)
再鼎医药（上海）有限公司
- 公司规模：500-1000人
- 公司性质：外资（非欧美）
- 公司行业：制药/生物工程
职位信息
- 发布日期：2020-11-24
- 工作地点：上海-浦东新区
- 招聘人数：1人
- 工作经验：5-7年经验
- 学历要求：博士
- 职位月薪：2.5-3.5万/月
- 职位类别：生物工程/生物制药
职位描述
? Collaborate with line management in setting the BA outsourcing strategy and providing the timeline coordination for clinical studies.
? Partner with QA and CP colleagues to identify and qualify the BA CROs, and coordinate CROs in terms of protocol drafting, study monitoring and report delivery to ensure timely and smooth workflow and in the meantime to ensure guidance are met all along.
? Leading the BA team and engage with CROs for trouble-shooting and continuous improvement to deliver against all agreed BA objectives.
? Provide scientific input and represent clinical pharmacology group in project teams, including timely written and oral communication of program related issues to multidisciplinary teams and raise up the solutions from BA perspective.
? Supporting the regulatory inspections or audits for Zai Lab sponsored studies, and address the queries from regulatory agency timely.
? Contribute to a positive and cohesive work environment that fosters teamwork, innovation and professional development.
职位要求：
Basic Requirements:
1) Master or Ph.D. degree or equivalent in a life/biological science or quality-related field, or equivalent combination of education, training and experience.
2) At least 5 years working experience in pharmaceutical industry and demonstrated BA/PK expertise.
3) Thorough understanding of bioanalytical assays, including the PK, ADA and Nab assays. Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.
4) Excellent interpersonal, leadership & organizational skills to negotiate priorities with stakeholders and help foster a collaborative environment with colleagues across sites and across disciplines.
5) Excellent/accomplished communication skill, facilitation, influencing, and strategic thinking skills within the organization, good at data analysis and presentation.
6) Ability to proactively identify issues, propose solutions and troubleshooting, and work in a team as well as to work independently with limited guidance or supervision
7) Good English (written and spoken) and Chinese
Preferred Requirements:
Relevant to the role, but not critical/essential
? Much experience with regulatory authority inspections
? Experienced for large molecule bioanalysis.
? Experience with clinical pharmacology knowledge.
? Partner with QA and CP colleagues to identify and qualify the BA CROs, and coordinate CROs in terms of protocol drafting, study monitoring and report delivery to ensure timely and smooth workflow and in the meantime to ensure guidance are met all along.
? Leading the BA team and engage with CROs for trouble-shooting and continuous improvement to deliver against all agreed BA objectives.
? Provide scientific input and represent clinical pharmacology group in project teams, including timely written and oral communication of program related issues to multidisciplinary teams and raise up the solutions from BA perspective.
? Supporting the regulatory inspections or audits for Zai Lab sponsored studies, and address the queries from regulatory agency timely.
? Contribute to a positive and cohesive work environment that fosters teamwork, innovation and professional development.
职位要求：
Basic Requirements:
1) Master or Ph.D. degree or equivalent in a life/biological science or quality-related field, or equivalent combination of education, training and experience.
2) At least 5 years working experience in pharmaceutical industry and demonstrated BA/PK expertise.
3) Thorough understanding of bioanalytical assays, including the PK, ADA and Nab assays. Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.
4) Excellent interpersonal, leadership & organizational skills to negotiate priorities with stakeholders and help foster a collaborative environment with colleagues across sites and across disciplines.
5) Excellent/accomplished communication skill, facilitation, influencing, and strategic thinking skills within the organization, good at data analysis and presentation.
6) Ability to proactively identify issues, propose solutions and troubleshooting, and work in a team as well as to work independently with limited guidance or supervision
7) Good English (written and spoken) and Chinese
Preferred Requirements:
Relevant to the role, but not critical/essential
? Much experience with regulatory authority inspections
? Experienced for large molecule bioanalysis.
? Experience with clinical pharmacology knowledge.
职能类别：生物工程/生物制药
公司介绍
Zai Lab is an innovative biopharmaceutical company based in Zhang Jiang, Shanghai focused on bringing transformative medicines for cancer, autoimmune and infectious diseases to patients in China and around the world. Zai Lab focus on innovation to meets the unmet medical needs. Zai has built up a strong pipeline with multiple programs on clinical stages. Zai Lab successfully listed on Nasdaq in Sep. 2017.
再鼎医药是一家总部设立于上海张江，致力于研究、开发和销售创新药物的制药企业。再鼎医药针对目前尚无良好治疗手段的疾病领域开发新药，在肿瘤、抗感染、自身免疫等方面建立了全面的产品线，服务中国和全球病患。再鼎医药于2017年9月在美国纳斯达克成功上市。
再鼎医药是一家总部设立于上海张江，致力于研究、开发和销售创新药物的制药企业。再鼎医药针对目前尚无良好治疗手段的疾病领域开发新药，在肿瘤、抗感染、自身免疫等方面建立了全面的产品线，服务中国和全球病患。再鼎医药于2017年9月在美国纳斯达克成功上市。
联系方式
- 公司地址：地址：span上海浦东张江高科技园区金科路4560号金创大厦3号楼8楼