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CMO 面议

广州市 10年以上 博士 临床试验
五险一金、定期体检、节假日福利、绩效奖金
立即申请

广州华津医药科技有限公司

企业 | 50-99人

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职位描述
01

岗位职责

Essential Duties and Responsibilities: 1.responsible for the strategy, direction and execution of the company’s clinical development plans. 2.Orchestrate and manage clinical aspects of regulatory strategies and interactions with Health Authorities 3.Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results 4.Lead interactions with academic thought leaders, investigators, cooperative groups, and other clinical stakeholders 5.Provide clinical support and work with other members of the management team to develop and communicate the overall corporate strategy 6.Represent the Company and its programs to external audiences, including the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators/partners 7.In addition to leading and supervising the Clinical Research Department the CMO will have direct line responsibility for the Clinical Operations, Patient Advocacy, Medical Affairs, and Biometrics Departments
02

任职要求

Qualifications and Skills: Must read, write and speak fluent Mandarin 1.Ph.D./M.D. in clinical medicine, oncology or related disciplines 2.15 years minimum experience in clinical practice treating patients and pharmaceutical and/or biotechnology industry experience as a sponsor working on investigational new drugs. 3.Multiple years of management experience leading a clinical group including clinical/medical affairs and clinical operations, 4.A proven success record in Phase I-IV clinical research studies and trial design as well as the successful submission of IND’s and marketing approval-directed filings (BLA’s, NDA’s, and MAA’s) 5.Knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities; experience in interactions with FDA personnel is essential; experience in interactions with other health authorities a plus 6.Experience in global multi-center trials 7.Experience with, or strong knowledge of Oncology drug development 8.Experience or knowledge of Orphan or genetic rare disease drug development a plus 9.Must have a thorough knowledge of clinical research concepts, practices, and GCP and ICH Guidelines. 10.Must have excellent communication skills and will be capable of articulating the Company’s clinical and regulatory strategies and progress to a wide audience including the CEO, the Board of Directors, Company employees, and the investor community. 11.Must have excellent leadership and interpersonal skills; should have proven skills as an effective team player who can engender credibility and confidence within and outside the company; must have outstanding executive presence.
03

工作地点

单位介绍查看所有职位>>

广州华津医药科技有限公司是一家致力于创新型生物抗肿瘤药物开发和生产、以满足全球恶性肿瘤治疗市场需求的生物制药公司。自2016年成立以来,在赵子建博士等四位特聘专家的带领下,通过数十位科研人员共同努力,公司逐步建立了全球首个快速广谱溶瘤细菌技术平台,并完成了核心产品溶瘤细菌桑美威克   的临床前研究、CMC生产工艺开发以及符合GMP标准的规模化生产设施建设。先发核心产品桑美威克已取得了FDA的3项ODD认证;FDA的2项IND批件,国内NMPA的2项IND批件及台湾的TFDA的IND批件。目前美国、台湾已经启动针对多种恶性实体瘤的I/IIa期临床试验,国内也将很快启动临床实验。

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