Job Responsibilities - To lead the team of NCS & DMPK (Non-Clinical Safety & Pharmacokinetics) Experts China. - To ensure the scientific contents, timely preparation and submission of NCS & PK dossiers in China for both CTAs and NDAs. - To represent NCS & DMPK in relevant local governance forums. - To support and coordinate the local DMPK analysis activities. - To help ensure the China requirements into the development life-cycle. - To explore and participate in the global NCS & DMPK activities. - To help reinforce the liaison between company and China HA & industrial consortia. - To lead the team to explore the potentials in NCS/DMPK activities in China via various internal and external resources, including innovative technologies and service collaborations. - Lead the team of NCS & DMPK Experts China in providing technical support to CMC dossier related activities for China CTA and NDA submissions; coach and develop team members. - Ensure the NCS & DMPK Experts China team to work closely with Medicine relevant functions (e.g., LRA, TAs, Clin Ops) as well as Local (Early) Asset Teams in ensuring timely and quality submissions. - Fully understand the plan, progress, and status of the pipeline development projects in China and reflect the information properly to global NCS & DMPK relevant functions; manage the resource and workload of the team and prioritize projects/ activities as applicable. - Identify areas of needs and opportunities to build relationships with Chinese regulatory agencies and institutions (e.g., NMPA/CDE/NIFDC), based on proactive work with China functions (primarily LRA), Global NBE/NCE Development functions and industry consortia (e.g., RDPAC/DIA). - Provide technical input or leverage expertise within Global NCS & PK for addressing NDS and DMPK topics specific to China; strategically work with global DMPK in implementing local PK analysis readiness and execution. - Explore to integrate NCS & DMPK Experts China team into Global NCS & DMPK functions; lead the team to take relevant global roles and responsibilities as aligned. - Explore the external industrial and academia opportunities for collaborations on innovative technologies and services..
Job Requirements - PhD (in biochemistry, biology, or chemistry), DVM (Doctor of Veterinary Medicine), MD or equivalent degree from an accredited institution with more than 10 years related experience, or relevant MS degree and more than 13 years related experience. - At least 5 years of experience in regulatory supporting activities in China with regard to non-clinical/clinical safety/ DMPK studies, preferably in pharmaceutical industry. - Demonstrates solid knowledge in field of toxicology and/or DMPK; possessing practical knowledge of pharmaceutical toxicology and/or DMPK including approaches to development toxicology/ DMPK, relevant regulatory guidelines and preparation of submission documentation. - Demonstrated or high potential in technical and people leadership. - Excellent planning and organizational skills. - Demonstrated ability to work effectively in a team environment. - Entrepreneurial thinking and can-do attitude. - Strong interpersonal & communication skills; excellent ability to communicate effectively both orally and in writing in an interdisciplinary environment. - Fluent in both Chinese and English. - Willingness to travel on as needed (Germany, US, China).
