北京招聘

?    Primary accountability for developing indication selection and translational biomarker strategies in collaboration with Research and Clinical Teams that assess proof of target engagement, and/or pharmacodynamics activity, establish early signs of efficacy, enabling proof of concept studies, and understanding disease progression
?    Partner with drug discovery scientists to design and execute translational research to discover and validate pathways and biomarkers associated with mechanism of action and drug response.
?    Provide key biological validation by leveraging insight gained from patient-derived functional, genetic, and biochemical biomarkers.
?    Develop and coordinate patient selection, biomarker and companion diagnostic strategies for projects across Zai’s growing portfolio
?    Support global regulatory strategy and contribute to the generation of investigator brochures, IND applications, clinical protocols and other regulatory documents as appropriate. Supports scientific input and review of all translational medicine aspects of clinical and regulatory documents, including but not limited to development plans, study protocols, clinical study reports, regulatory submissions and responses to any regulatory questions, etc.
?    Work closely with discovery stakeholders to understand evolving project portfolio, identify knowledge gaps related to target diseases, and prioritize resources needed for specific assets
?    Partner with discovery colleagues on biomarker-related internal studies, consortium work, or academic collaborations as needed
?    Consult with project teams on biomarker discovery, pre-strategic assessment of indications for clinical samples profiling and understanding of mechanism or disease related biology
?    Collaborate with research and clinical colleagues to develop scientifically rigorous translational and exploratory biomarker strategies that assess proof of mechanism, establish early signs of efficacy, enable proof of concept studies, and generate an understanding of the variability in patient response
职位要求：
?    Advanced science degree (PhD,  or MD) with 8 or more years of related experience focused on immunology and or oncology.
?    Minimum of 5 years of hands-on expertise developing and executing preclinical studies/assays.
?    Demonstrated knowledge of designing, implementing and conducting studies for biomarker discovery, validation, and qualification using human biomaterials to produce both timely and good quality data.
?    Strong communication skills (oral, written, and presentations).
?    Up-to-date working knowledge and understanding of regulatory and quality guidance and requirements related to the general principles for development and validation of assays for biological products.
?    Experience with all phases of pre-IND through Phase I/II/III programs and associated regulatory filings.
?    Ability to operate independently with minimal supervision

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。