北京招聘

The job holder design and ensure successful conduct of clinical studies and review study results. He/she is core members in project team and responsible for compound’s development strategy and plan.

· Development strategy and plan (including protocols) for all portfolio projects

· Ensure successful conduct and integrity of all in-scope clinical studies (i.e., providing medical monitoring) · Co-owners of clinical study delivery

· Development documents (CIB, protocol and CSR, ETC) content owner

· Analysis and interpretation of clinical study results in partnership with clinical development functions

· Forming and running advisory board for portfolio projects;

Be responsible for interacting and communicating China KOLs for development strategy and protocol design

· Liaise with safety physician for program-level assessment of safety information, evaluation of safety signals, regulatory compliance of safety reporting including updating safety profile in the Investigator’s Brochure, Risk Management Plan, DSUR, etc.

· Liaise with clinical pharmacologist on PK/PD programs to ensure the deliverables

· Setting strategic direction for addressing medical issues in regulatory submission and communication/interaction · Be a clinical science expert and supporting regulatory filing and registration

· Be a clinical science expert and leading discussions with regulatory officials on clinical science subjects of a given project

· Be the clinical science physician and providing consultation to clinical operation colleagues on protocol design questions and answering protocol related questions from site investigators

· Liaise with other functions to support pre-launch marketing activities, publications, conferences and early market access to the compounds

· Maintain up-to-date medical/scientific knowledge as well as clinical trial landscape and competitive intelligences

Academic / Professional Qualification 学历要求

• Medical Degree

Technical / Skills Training技术资质

• Disease Knowledge
• Patient journey
• Treatment guidance
• Compound knowledge
• Regulatory guidance for the therapy area
• Medical monitoring
• Safety reporting and Risk Management Plan
• CSP/CSR content & data analysis
• Presentation & communication skill
• Prioritize and focus with attentive to detail and excellent analytical skill

Working Experience工作经验

3-5 years of clinical development experience (at least as clinical research physician for 3 years) in pharmaceutical and/or biotech industry

    迪哲医药的前身为阿斯利康亚洲及新兴市场创新研发中心，设立于中国上海，是阿斯利康全球四个研发中心之一（另三个中心分别位于英国剑桥、瑞典哥德堡、美国盖瑟斯堡）；是国际一流、高产出的创新药研发机构，拥有全球领先的转化医学和新药分子设计与筛选技术平台；在恶性肿瘤、自身免疫性疾病、肾病等重大疾病的新药研究方面积累了丰富经验。
    迪哲医药，于2017年10月独立运营，是一家研发驱动型生物医药企业，致力于全球创新药物（First-in-class/ Best-in-class）探索、研发以及商业化。
    详情请点击公司官方网站：**************************/

Dizal Pharma
On Nov. 27th, 2017, through a joint venture between AstraZeneca and China Advanced Manufacturing Fund, Dizal Pharma was co-constructed as a world-leading innovative bio-pharmaceutical enterprise. As a new, unique mode of cooperation between SDIC Fund Management Company Ltd. and worldwide privileged research resources in the field of biological pharmacy, Dizal Pharma can not only accelerate the launch and listing of global new drugs in China, bring Chinese patients access to the latest drugs found across the world at once and thus raise the clinical benefits of patients; At the same time, we also take advantages of the global privileged innovative resources, increase China’s core competitive power in the innovation of new drugs, step in the leading branch of international research and development of new drugs and push China into the role of causing both huge and powerful influence in pharmacy industry.
As a new-style joint venture company, besides the project of the transfer of AstraZeneca’s patents, Dizal Pharma also develops the innovation and creation of global First-in-Class drugs.
The R&D (Research and Development) team of Dizal Pharma was AstraZeneca Asia and Emerging Market Research Center. As one of AstraZeneca’s first four R&D centers across the world, it dedicated to analyze the potential scientific mechanism of those most common diseases in Asia and fulfill the particular medical needs of Asian patients. It was one of the few R&D centers established by transnational pharmacy enterprises in China which had the ability to actually research, develop and produce micro-molecular new drugs, the ability to develop produce new drugs independently and completely, and the first-class medical platform in the world.