Pharmacokinetics Head (15m-20m JPY)

    Tokyo 23 Wards Permanent ¥1,500,000 - ¥20,000,000 Foreign Multinational
  • 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

Job Description



  • 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).

The Successful Applicant

  • 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
  • Solid relationship building skills and strong interpersonal skills.

What's on Offer



  • 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

Job summary

Function
Healthcare
Specialisation
Healthcare
Industry
Healthcare / Pharmaceutical
Location
Tokyo 23 Wards
Job Type
Permanent
Consultant name
Ed Marsden
Consultant phone
+813 6832 8981
Job Reference
JN-112021-4541213
Company Type
Foreign Multinational