About this role
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.
Responsibilities - Trial Clinical Pharmacologist-China (TCP-CN) supports the clinical drug development of new drugs and further development of approved drugs by providing clinical pharmacology input and by developing clinical pharmacology part of clinical trial protocols and clinical trial reports as well as by supporting trial conduct (see TCP job profile). TCP-CN also supports Clinical Pharmacology Lead (CPhL)-Asia to plan and execute the clinical pharmacology development strategy in China and supports further development of approved drugs. - TCP-CN supports communication with China regulatory authorities and proofreads official documents (e.g., briefing book, slide deck, CTD Sections 2.7.1 and 2.7.2). - Under the direction of the global Clinical Pharmacology and in cooperation with CPhL-Asia, TCP-CN facilitates the communications with China teams to collect local needs appropriately and ensures that the goals and objectives are met. - TCP-CN may serve as CPhL-Asia (see CPhL-Asia job profile) for assigned projects. Qualifications - Master’s degree in medicine, Pharmaceutics, Clinical Pharmacology, or equivalent area of focus with a minimum of 3 years relevant experience in Clinical Pharmacology in the pharmaceutical industry, regulatory agencies, or academia could be considered for this position.
Doctoral degree (MD or PhD) in Medicine, Pharmaceutics or Clinical Pharmacology or equivalent area of focus with 0-3 years relevant Clin Pharm experience in the pharmaceutical industry, regulatory agencies, or academia preferred. - Very good knowledge in PK and PK/PD, clinical pharmacology, biopharmaceutics, clinical drug development and relevant regulatory guidelines. - Very good knowledge in pharmacokinetic software programs (e.g., Phoenix WNL), and graphic software packages (e.g., SigmaPlot). - Good understanding of pharmacometric tools (modeling and simulation), their opportunities and limitations as well as basic understanding of statistical principles especially with respect to Clin Pharm trial data. - Excellent communication and presentation skills. - Highly independent, diligent. This role requires a high standard in social skills (Good Team-player). Along with efficient analytical thinking and working methods also a great awareness of responsibility and interest in interdisciplinary work is needed. -Good command of English and Chinese