DMPK Project Leader
Responsibility:
- Develop and integrate the DMPK strategy to maximize value across integrated drug discovery programs.
- Represent DMPK as a key function in drug discovery project teams and understand the aim of the project (indication, pharmacological target and the target product profile).
- Design and ensure appropriate experimental studies and related reporting as support to compound multi-parameter optimization, project progression and preclinical candidate selection.
- Ensure selection and utilization of appropriate in vitro, in vivo, or in silico methods and models to address absorption, metabolism and pharmacokinetic-related DMPK issues.
- Design, outsource and manage non-GLP and GLP DMPK and toxic-kinetic (TK) studies in support of projects from discovery to early development, and write regulatory documents and package towards IND and NDA (e.g. IND, IMPD, IB and NDA).
- Participate in the selection and management of CROs for the conduct of in vitro/in vivo ADME studies, including IND-enabling studies and studies to support clinical development
Requirement:
- PhD in Pharmaceutical Sciences/Chemistry/Biochemistry, with 3-5 year industrial experience
- Strong expertise in DMPK of small molecules (large molecule experience would be an added value) and robust knowledge in PK and PK/PD modelling and application to human efficacious dose prediction
- Significant experience in influencing and impacting project teams in early discovery is considered as critical,
- Excellent oral and written communication skills and an ability to interact and conduct strategic planning with colleagues in other scientific disciplines.
- In-depth knowledge of the overall drug discovery process and demonstrated ability to successfully direct efforts on multiple projects simultaneously.
- Demonstrated capability to mentor junior scientists and manage in a matrix environment
- Fluent in spoken English and good in written.
Violet Wang Tel/Wechat:13386179707,Email: [email protected]