Director, Development ADME Lead

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Job Description

Objective / Purpose:

The ADME Sciences team at Takeda plays a critical role within the global DMPK&M organization, integrating deep scientific expertise across enzymology and transporters, biotransformation, and biodistribution areas. Together, these functions shape and drive ADME strategies across all stages of drug discovery and development. We are seeking a Development ADME Lead to provide strategic, scientific, and operational leadership across Takeda’s development-stage ADME portfolio. This role is pivotal in advancing programs through thoughtful design, oversight, and execution of ADME strategies, while maximizing the efficiency of internal capabilities and external partnerships. 

• Provide strategic direction and scientific leadership for development ADME activities from candidate nomination through IND-enabling studies and regulatory submissions (e.g., IND, NDA, BLA).
• Serve as the primary point of accountability for outsourced development ADME deliverables, including in vitro ADME, biotransformation, and biodistribution studies.
• Drive continuous improvement initiatives by optimizing development ADME processes and promoting scalable, agile, and sustainable operations.
• Strengthen global ADME collaboration by implementing effective communication strategies and fostering alignment across geographically distributed teams.

Accountabilities:

• Define and lead the external innovation strategy for ADME Sciences. Oversee scientific and operational aspects of external partnerships and CRO collaborations to support early- and late-stage development projects.
• Serve as subject matter expert for development ADME in regulatory submissions, guiding protocol development, troubleshooting studies, reviewing data, directing report generation, and managing timelines.
• Collaborate with internal ADME scientists and DMPK project representatives to enhance global ADME infrastructure, streamline reporting workflows, and improve timeline management.
• Partner with DMPK representatives to prepare and refine ADME sections of regulatory submissions, ensuring clarity, scientific rigor, and compliance with global regulatory standards.
• Manage development ADME resources efficiently to support global ADME objectives and optimize the balance between internal and external capabilities.
• Develop tools and frameworks to enhance global collaboration, ensuring alignment and seamless communication between Takeda’s global ADME teams (e.g., TBOS and TSHO).

Education & Competencies (Technical and Behavioral):

Education Background

• Bachelor’s degree with 18+ years of DMPK experience, specializing in development ADME, with a primary focus on CRO management and direct CRO work; MS with 16+ years of experience; or PhD with 10+ years of experience.

Technical Expertise

• 10+ years of hands-on experience in in vitro development ADME, including report writing for regulatory submissions.
• 10+ years managing preclinical and clinical mass balance and biotransformation studies, with a strong regulatory track record.
• 5+ years of direct regulatory submission experience for DMPK sections (IND, NDA, BLA) with a proven track record of success on multiple approved small molecules and biologics. Advanced knowledge of regulatory guidance for industry applicable to the design and analysis of ADME studies.
• 5+ years managing and conducting preclinical PK/TK studies including NCA analysis and authoring corresponding reports.
• 5+ years of direct experience in regulatory filing with cross-functional interfaces including key partners such as Research, Drug Safety, Clinical Development, Regulatory Affairs, and Medical Writings.

Project and People Management

• 10+ years of project management and coordination experience, demonstrating the ability to drive complex initiatives to completion.
• 5+ years of people management experience including direct supervision of a subfunctional ADME or other DMPK teams.

Analytical and Communication Skills

• Strong analytical abilities to interpret complex data and present findings clearly to diverse audiences.
• Exceptional organizational skills with the ability to multitask, prioritize, and execute efficiently in dynamic environments.
• Executive presence and excellent communication skills, with a collaborative and solution-oriented mindset.

Innovation and Continuous Improvement

• Proven ability to lead innovation initiatives to enhance efficiency, scalability, and impact of internal and external ADME and DMPK operations.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Boston, MA

U.S. Base Salary Range:

$174,500.00 - $274,230.00

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

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