Pharmacokinetics Head (15m-20m JPY)

Exciting global pharmaceutical company setting up in Japan
Work across a diverse range of projects with different drug modalities and a bre

About Our Client

A well-established multinational pharmaceutical business with growing presence in Japan

Lead the strategy, planning, design, and oversight of the execution of in vitro ADME assays and non-clinical studies to understand the PK and ADME of compounds.
Integrate DMPK data/principles with pharmacology and toxicology profiles and will work cross-functionally on project teams, providing scientific leadership and strategic direction.
Monitor work with CROs/external vendors to ensure compliance with agreed protocols, quality standards and timelines.
Review internal/external data, lead the analysis, interpretation and reporting of ADME, and non-clinical and clinical pharmacokinetic and pharmacodynamic data.
Effectively communicate DMPK knowledge and strategy to project teams, functional leaders, and other key stakeholders.
Co-author regulatory submission documents (CTD, Investigator brochure (IB), EOP2 meetings, BLA).

As a member of the global organization, business level English is a very important requirement for this position. Fluency in Japanese is also mandatory.
Higher degree in life sciences (e.g., pharmaceutical sciences, PK, drug metabolism or a related field) with extensive experience in the pharmaceutical industry
Solid knowledge of metabolism and ADME (metabolic stability, DDI, plasma/tissue binding, etc), PK, PK/PD, and bioanalytical principles.
Broad understanding of various DMPK relevant areas such as physiochemical properties, drug metabolizing enzyme and transporter kinetics, mechanistic biotransformation, in silico predictions, and qualitative and quantitative bioanalytical techniques.
Fluency in Model-Informed Drug Development and the ability to integrate in silico, physiochemical, and DMPK data.
Demonstrated track record and ability to manage the DMPK/pharmacokinetic components of development projects.
Up-to-date knowledge on regulatory guidance pertaining to ADME/DMPK.
Proficient and experienced in using common data analysis software packages (such as Phoenix WinNonlin/NLME, Simcyp, R, SAS, and other tools).
Excellent project management skills.
Ability to participate and work effectively on multiple cross-functional teams

Highly visible position in a fast-growing international pharmaceutical company in Japan
Report to Head of R&D in Japan with dotted report line to global

Contact

Ed Marsden

Quote job ref

JN-112021-4541213

Phone number

+813 6832 8981