长沙招聘

Job Description

This senior level CMO, Sr.  VP, Clinical Development, supports Bio-Thera decision-making and product  R&D by leading the company’s global clinical development. We are seeking an  experienced, motivated individual to serve as the Chief Medical Officer. She/he  will take full responsibility for the company’s clinical strategy, development  and operations plan. The Chief Medical Officer will join the company’s senior  leadership group.

  Major Responsibilities:

  ?   Direct and oversee the design and implementation of all  stage clinical projects.

  ?   Ensure that all clinical programs have sound scientific and  medical basis. 

  ?   Prepare and direct overall clinical development plans;  Design scientifically rigorous clinical development programs for the various  indications. 

  ?  Monitor study progress, leading the analyses and data evaluation  process for progress reporting and presentations to internal senior management  team and external advisory and other relative groups.

  ? Prepare briefing and regulatory documents for regulatory agencies, such  as Dossiers, NDAs, INDs, Safety and Annual reports, and communicate with and  responses to regulatory agencies about medical and other related issues.

  

Requirements

            ?   MD  or equivalent, or medical scientist with sub-specialty training in oncology; 

  ?   Experience in clinical protocol design and implementation;

  ?   Eight or more years of biotech or pharmaceutical industry  related experience is required. Must demonstrate knowledge of clinical trial  management, data management, and drug development process, and leadership  skills in various settings of clinical and regulatory processes.  

  ?   Excellent oral and written communication skills, as well as  interpersonal skills.

  ?   Hard working, driven to achieve creative and sound results.

  ?   Previous experience with leadership, collaboration,  teamwork, and proven track record of success in design and implementation of  phase II-III trials, oncology, autoimmune or related areas is a plus.

  ?   Experience in working effectively in multicultural  environments is a plus.  

The company is headquartered in Guangzhou, China, and the position is full-time and based in Guangzhou. International travel is required. Bio-Thera provides competitive compensation package including company stock.

百奥泰生物制药股份有限公司（股票代码：688177）秉承“创新只为生命”的理念，致力于开发新一代创新药和生物类似药，用于治疗肿瘤、自身免疫性疾病、心血管疾病以及其它危及人类生命或健康的重大疾病。公司已推动五款候选药物进入后期临床试验，其中格乐立（阿达木单抗）已在中国获批用于治疗类风湿关节炎、强直性脊柱炎、银屑病、克罗恩病和葡萄膜炎。此外，公司另有多款主攻肿瘤和自身免疫性疾病的候选药物处于不同的临床开发阶段。公司始终以患者的福祉作为首要核心价值，通过创新研发为患者提供安全、有效、可负担的优质药物，以满足亟待解决的治疗需求。欲了解更多信息，请访问公司官网或关注我们的微信公众号“百奥泰”。
Bio-Thera？Solutions, Ltd.a leading commercial-stage biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next-generation antibody discovery and engineering, the company has advanced five candidates into late stage clinical trials, one of which, QLETLI, a biosimilar to？Humira？(adalimumab), is available to patients with rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis,？Crohn's disease or uveitis in China. In addition, the company has multiple candidates in early clinical trials and IND-enabling studies, focusing on innovative targets in immuno-oncology and autoimmune diseases.