Website Kanghong Pharmaceutical
DMPK (Director/Senior Director)
Main Job responsibilities:
The primary responsibility of this position is to provide DMPK strategic and technical expertise and representation for discovery and development programs.
1、Responsible for providing DMPK/BA strategies and professional guidance to project teams in all treatment fields.
2、Provide scientific leadership and oversight of the DMPK/BA; working closely with Discovery, Chemistry, Toxicology and Clinical colleagues/CROs.
3、Establish and maintain appropriate quality systems and procedures for outsourcing, managing and reporting for DMPK/BA studies and other activities in support of portfolio programs, and provide submission-ready documentation for the DMPK/BA components of regulatory submissions.
1、10+ years industry-related experience in discovery and development DMPK/BA working within the biotechnology, pharmaceutical or CRO industry.
2、Hands-on experience in all aspects of DMPK study conduct, including: study design, execution, interpretation and reporting, in vitro/in vivo PK & PD and ADME, methods, animal models, inter-species scaling, advanced data analysis, reporting and compliance.
3、Rich experience in external collaboration and supervision of DMPK/BA research.
4、Rich experience in data analysis and BA research.
5、Experience with WinNonLin PK model is preferred; those with experience in PK/PD and PBPK model establishment and design for the first-in-human medicine and isometric exploration are preferred.
6、Candidate experienced in ophthalmology or CNS area is preferred.
7、Highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards.
8、Provide strong management skills and demonstrate ability to manage and lead internal and external resources.
9、PhD in related disciplines.