Senior Director, Drug Metabolism Pharmacokinetics & Modeling

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 leadis 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 TeamRepresentatives 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. 

• Interacts directly with DDU and TAU head (or designee) to determine goals, strategy, and execution of the development of drug candidates. 

• Is actively participating in the DDU and TAU leadership discussions and decision-making.  

• Provides scientific and strategic expertise to DMPK Project Team Representatives for the development of TA drug candidates. 

• Reviews and advises on data, reports, scientific conclusions, and presentations 

• Approves DMPK components of drug strategy for all GI2 projects at appropriate milestones, reviews and approves the appropriate sections of internal project documentation. 

• Is well-informed on the latest trends in the competitive and regulatory landscape, particularly as it relates to specific therapeutic area. 

• Aligns goals and resources with DDU and TAU, and communicates those needs to DMPK Head, and other DMPK functional leaders, as needed. 

• Consults with Head of ADME, Bioanalytical, Biomarker, Translational Partners, and New Modality Support Teams and line function Heads to ensure that appropriate personnel from their lines are assigned to projects at the appropriate time 

• Reviews and approves regulatory documents and correspondence on behalf of DMPK 

Education & Competencies

• PhD with 15+ years’ industry experience or equivalent (MS with 21+ years’ experience, or BS with 23+ years’ experience) 

• Good understanding of the GI2 (Inflammation & Immunology DDU/TAU project portfolio, disease indications, and typical DMPK considerations for patients  

• Experience of working with multiple modalities ideally small molecules, ASOs, gene therapy, cell therapy and biologics 

• Experience in all stages of drug development from discovery to marketed product support 

• Experience in making recommendations to senior management of other line functions regarding key program decisions.  

• Experience in regulatory submission (INDs, CTA, NDAs, MAAs) and in health authority (FDA, EMA, PMDA) interactions, and experience in developing strategies around those interfaces in collaboration with the Regulatory function 

 This position is currently classified as “hybrid” by Takeda’s Hybrid and Remote Work policy.