To support drug R & D in the aspects of preclinical development, including planning, conducting, supervising and reporting the preclinical phase of the drug development. To make sure the in vitro tests and animal studies’ data are comprehensive and robust to support the FIH/trials in human.
- provide PKPD input to R & D of new drugs, and collaborate and support on cross-functional drug development teams and departmental initiatives;
- Oversee the pre-clinical development of new drugs and create the development plan;
- lead the (pre-clinical) pharmacology group in terms of reviewing protocols and documents for regulatory purposes, and CRO selections;
- ensure the pre-clinical studies complaint with the corresponding regulatory guidelines;
- Provide interpretations of data and results and report to cross-function project teams regarding the benefit-risk assessment;
- ensure the pre-clinical development is comprehensive and sufficient to support the FIH/clinical trials;
- Maintain up-to-date knowledge with regard to innovative approaches in PK/PD and bring the knowledge in the group.
Qualifications and abilities:
A qualified candidate should obtain Master degree of pharmacology, pharmacokinetics, pharmaceutical sciences or other medicine related degrees as minimum. The working experiences of drug pre-clinical development, DMPK, PKPD, DDI and/or PBPK with at least 3-5 years in pharmaceutical companies, consultant agencies, regulatory agencies or CROs. Advanced fluency in English in both speaking and writing is needed.
The candidate should have a mindset that patient and cure are the top. He/she is willing to take the responsibility of making go/no-go decision. He/she has a research mind, strong analytical skill and excellent communication skill. He/she likes to work in a team with different backgrounds, and is able to simplify the complex issue. He/she should have a clear mind and can pinpoint out the key issue, explain to the development team and the line manager, and come up with solutions.
Minimum Education: Master degree
Desirable Education: pharmacology, translational medicines,
Languages: Chinese (native), English (reading/writing/speaking).
Experience: ＞3 years.