Head of Development CMC China
- Shanghai
- Permanent
- Full-time
- Set up the Development China functions by recruiting and on-boarding talents
- Manage and retain talents with proper career development mapping
- Provide necessary technical training and input to the function leads and team members
- Ensure the timely and quality delivery of functions within Development China, such as CMC Experts, Science & Technology scouting & external collaborations, CRO management & technical support, and Investigational Medicinal Product (IMP) coordination
- Explore potential Development opportunities in China and drive the implementation
- Regularly update and align with Global Development and local senior management on progress and strategic trends that have strategic impacts on Global Development
- Enable Global Development and local senior management to further refine China strategy
- Lead and/or participate in global and local initiatives to help incorporate China requirements and mandates into Global Development project life cycles
- Leverage expertise and resources in Global Development for project implementation and knowledge sharing in China
- Lead and reinforce the connections to Global Development (and beyond as needed) functions to understand the global strategy and needs
- Lead and reinforce the connections and collaborations with local functions (esp. T.C.M. Medicine and Research Beyond Board, Venture Fund, Business Development & Licensing) to make tangible contributions in activities in China
- Build relationships with Chinese regulatory agencies and consortia (e.g. NMPA/CDE/NIFDC/Chinese Pharmacopeia/RDPAC/DIA) to contribute to improving ecosystem of China pharmaceutical industry
- PhD degree with more than 12 years or MS degree with more than 15 years of professional experience in global pharmaceutical industry, preferably having oversea experiences;
- Broad experience in new chemical entity development
- Experiences in regulatory science and Health Authority interactions with good understanding of the ICH regulations
- 6+ years of managerial/leadership experience in pharmaceutical industry
- Familiar with CMC technical aspects of the China submission process and requirements for new chemical drugs
- Understanding innovation drug research, discovery & development life-cycle
- Entrepreneurial thinking and attitude
- Excellent interpersonal & communication skills
- Excellent planning and organizational skills
- Willingness to travel on a regular basis (ING/BC, US, China)
- Fluent in both Chinese and English
- Capability of working in an international team across the Globe; project leadership capability;
- Self-motivated, hard-working, good learner, detail-minded, clear thinker, quick learner, team player and ability to work independently under pressure.