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
Be responsible for leading China clinical development plans and ensuring effective and efficient execution of the development plan.
- Lead and Drive generation/updating of responsible new compounds /indications' China clinical development plan including integration into global projects, China-lead projects, etc.; Drive local project team to ensure deliverables in clinical development for the T.C.M.
- Build up and maintain close working connections with key stakeholders from internal, including both Corporate and local related cross functions from drug development and commercial; and external HA-reviewers/ external clinical experts, etc.
- Scientifically lead all clinical documents, including but not limited to extended synopsis/protocols, study reports, briefing packages, and other IND application and NDA filing documents from medical perspective, etc.;
- Lead scientific input in interaction with health authorities including CTA/NDA submissions, pre-IND/NDA meetings, panel meetings, response for health authorities, etc.
- For China joining global trials, provide local medical support during trial execution; for China-lead registration trials, lead medical activities for trial execution.
Job Requirements
- At least 7 years or more clinical medicine training background, M.D., Ph.D.
- Over 5 years working experience in clinical practice and/or pharmaceutical experience in medical affairs/clinical development
- Strong willingness of self-learning;
- Outstanding verbal communication and written skills;
- Strong negotiation skills;
- Good teamwork spirit;
- Excellent presentation skills