CMC Scientific Director - New Biological Entity
Boehringer IngelheimShanghaiUpdate time: September 10,2019
Job Description
CMC Scientific Director - New Biological Entity-199692
Talent@Boehringer Ingelheim
About Human Pharmaceutical Business
With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, we will accelerate the launch of more than 10 innovative medicines to meet the demand of Chinese patients.
Job Responsibilities
- Identify areas of needs and opportunities to build relationships with Chinese regulatory agencies and institutions (e.g. NMPA/CDE/NIFDC/Chinese Pharmacopeia/RDPAC), based on proactive work with BI-China functions (primarily LRA), Global NBE Development functions and industry consortia; build the relevant relationships
- Provide technical input or leverage expertise within Global NBE Development related to CMC topics specific to China
- Monitor, translate, and communicate strategic changes related to CMC aspects of Biologics development in China to key stakeholders within Global NBE Development
- Support RA/CMC RA in preparation of submissions in China and in meetings with the authorities by providing scientific input and support personally and through the relevant experts in the global Development network
- Leverage existing network through RBB/BDL/Venture Funds and expand network by scouting and exploring enabling technologies relevant to biologics Development in China
If selected as the China Explorer Team Lead, additional responsibilities as the Team Lead include:
- Lead China Explorer Team to explore opportunities that have meaningful impact to enhance efficiency and capabilities of new drug development (NCE, NBE + ATMP)
- Liaise with other BI China functions (e.g. RBB, LRA, CoC, BioBU) to effectively create synergy and connections within China and with Global Development
- Liaise with regulatory authorities, governmental labs and relevant working pharma working groups and societies
- Regularly update and align with Development senior management (i.e. GDLT) on progress made by the China Explorer Team and strategic trends that have a strategic impact on Development
- Support Development senior management (e.g. GDLT) to shape future China strategy
- In addition to the above reporting lines, the China Explorer team lead will locally report to Wei Zhang, Head of Medical, TCM and functionally report to Fridtjof Traulsen, Global Head of Development. Travel may increase to 30% or above.
Qualifications
- PhD degree with more than 7 years of professional experience in global pharmaceutical industry, preferably having oversea experiences, and preferably BI experience
- Broad experience in new biological drug development, having expertise in analytical and combination product development is a plus
- Experiences in regulatory science and Health Authority interactions with good understanding of the ICH regulations
- 4+ years of managerial/leadership experience in pharmaceutical industry
- Familiar with CMC technical aspects of the China submission process and requirements for new biological drugs
- Entrepreneurial thinking and attitude
- Excellent interpersonal & communication skills
- Excellent planning and organizational skills
- Willingness to travel on a regular basis (Germany, US, China)
- Fluent in both Chinese and English
工作 - 研发
主要地点 - Africa, Asia, Australasia-CN-上海-上海
组织 - 勃林格殷格翰（中国）投资有限公司
编制 - 全职
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