Senior Director, Drug Metabolism Pharmacokinetics & Modeling

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Job Description

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Objective / Purpose:  

• Represents GI2 (Inflammation & Immunology) DDU, TAU andGI2 project portfolio as an engaged member of the DMPK&M Leadership Team. 

• Regularly and actively participates in appropriate DMPK LT meetings to give briefing updates on therapeutic area status, critical issues, and major milestones. 

• In partnership with DMPK&M lead is responsible for DMPK strategy and its execution for all GI2 DDU and TAU projects. 

• Runs and maintains regular operational/strategy meetings of all DMPK staff involved in supporting GI2 portfolio. 

• Is ultimately accountable for study protocol reviews to support DMPK Project Team Representatives in experimental design and data interpretation. 

• Reviews study reports and regulatory documents for scientific accuracy and consistency of human risk assessment message 

• Provides continuous mentorship and performance feedback to DMPK Project Team Representatives 

• Frequently interacts with the Global Head, DMPK partnership leads, fellow DMPK&M SPOCs and/or Heads of DMPK&M Sub-Discipline Functions to address questions on strategy and to anticipate and resolve potential issues. 

Accountabilities:                                          

• Provides strategic leadership across GI2 (Inflammation & Immunology) DDU and TAU representing DMPK. Makes strategic decisions in consultation with senior leaders to advance research projects from target selection to clinical submission. 

• Provides scientific leadership to ensure selection of clinical candidates with optimal drug development characteristics and appropriate characterization and development of these candidates.  

• Provides scientific and strategic guidance on stage-appropriate questions related to drug metabolism, bioanalysis, quantitative biomarkers, PK, and PK/PD. 

• Guides efficient design and execution of studies in support of drug candidates. 

• Oversees GI2 project portfolio as the DMPK Leadership Team nominee, ensuring that the DMPK strategy is in alignment with other functions in discovery and development.