IND-Enabling and Regulatory/Technical Program Management Director and above
- Work in a high motivated team and very dynamic environment, you will extend your potential to limitless. Position level will base on the individual experience and education background.
- Work with clients for preliminary studies selection and preliminary detailed study designs based on compound’s nature, clinical indication, intended clinical trial regime, data from previous studies, and the jurisdiction(s) the sponsor intends to submit.
- Scientific monitoring process of projects: RTPM will scientifically monitor all the process starting from lead optimization, pharmacology, DMPK (drug metabolism and pharmacokinetics), CMC, safety assessment (toxicology, pathology, analytical/bioanalytical), all the way through IND/CTA submission.
- Coordinate with sponsors and internal expertise to design appropriate studies to meet regulatory requirements, ultimately to meet the project needs. Stay on the top of project with continues scientific and technical support. Proactively identify potential issues and input the constructive suggestions.
- With or without supervision, prepare the regulatory submission documents and dossier writing for analytical/bioanalytical, pharmacology, DMPK, or/and safety assessment parts. Search and prepare scientific references for project needs.
- Interact with clients, other key functions/business units within WuXi AppTec to facilitate the project development. Directly communicate (visiting host, holding TC and auditing, etc.) with national and international sponsors.
- Dynamic study results discussion and consultation: Based on the collected updating data/results, RTPM will continually tune up the studies and process during the progress of project for the best outcome.
- Ph.D with 5 years and up or Master with 8 years and up relevant experience in in vitro /in vivo, CMC, or pharmacology, or DMPK, or safety pharmacology, or toxicology, or bioanalytical, experience on biologics will be plus
- Project manager experience (manage the preclinical program) must
- Biological science education background
- Experience in vitro or in vivo studies in research and drug discovery
- Regulatory background
- Regulatory writing experience will be a plus
- Excellent English and Chinese in verbal and writing
- Good interpersonal skill and teamwork spirit
- Capability to research and search information
- Potential for personal development within a short timeframe.
Any applications,pls contact:firstname.lastname@example.org;email@example.com