1. Leading roles in preclinical and early clinical studies, including but not limited to drug analysis in vitro and in vivo, and PK/TK support;
2. Lead cross-functional metabolic project teams (toxicology, pharmacology, clinical development, CMC, and others). Provide important feedback from the DMPK project team;
3. Lead the development of DMPK regulatory activities in Synth Pharmaceuticals, it helps to generate and review materials such as researcher's brochures, CTA, and Blas / MAA and all licensing activities to provide scientific support;
4. Manage cooperation and CRO / CMO outsourcing activities. Provisional and final deliverables in project schedules and budget requirements;
5,Guide experimental methods for the DMPK problem with other preclinical R & D senior staff ;
6. Contribute to departmental development, budgeting, and personnel development as a key member of the system's management team;
7. Responsible for ensuring all reported DMPK related reporting schedules. It is expected to review, edit, and provide critical feedback through CRO or subordinate generated reports.
1. Ph.D. or equivalent degree in related disciplines; at least 6 years of industry experience, experience in large-scale pharmaceutical and biotechnology, and at least 3 years experience as project manager or project representative;
2, Rich DMPK project support experience;
3. Experience in the preparation of regulatory documents, such as IND, CTD, NDA/BLA, etc.;
4, Strong professional knowledge, familiar with DMPK ICH, FDA, EMA guidelines and CFDA-related regulations;
5. Ability to establish cooperative relationships between the entire organization and external partners, such as CRO companies, universities, research institutions, and regulatory agencies;
6, Excellent expression and communication skills.