Director, Development ADME Lead Position Available In Suffolk, Massachusetts

Job Description:

By clicking the “Apply” button, I understand that my employmentapplication process with Takeda will commence and that theinformation I provide in my application will be processed in linewith Takeda’s Privacy Notice and Terms of Use . I further attestthat all information I submit in my employment application is trueto the best of my knowledge. Job Description Objective /

Purpose:

The ADME Sciences team at Takeda plays a critical role within theglobal DMPK&M organization, integrating deep scientificexpertise across enzymology and transporters, biotransformation,and biodistribution areas. Together, these functions shape anddrive ADME strategies across all stages of drug discovery anddevelopment. We are seeking a Development ADME Lead to providestrategic, scientific, and operational leadership across Takeda’sdevelopment-stage ADME portfolio. This role is pivotal in advancingprograms through thoughtful design, oversight, and execution ofADME strategies, while maximizing the efficiency of internalcapabilities and external partnerships. Provide strategic directionand scientific leadership for development ADME activities fromcandidate nomination through IND-enabling studies and regulatorysubmissions (e.g., IND, NDA, BLA). Serve as the primary point ofaccountability for outsourced development ADME deliverables,including in vitro ADME, biotransformation, and biodistributionstudies. Drive continuous improvement initiatives by optimizingdevelopment ADME processes and promoting scalable, agile, andsustainable operations. Strengthen global ADME collaboration byimplementing effective communication strategies and fosteringalignment across geographically distributed teams.

Accountabilities:

Define and lead the external innovation strategyfor ADME Sciences. Oversee scientific and operational aspects ofexternal partnerships and CRO collaborations to support early- andlate-stage development projects. Serve as subject matter expert fordevelopment ADME in regulatory submissions, guiding protocoldevelopment, troubleshooting studies, reviewing data, directingreport generation, and managing timelines. Collaborate withinternal ADME scientists and DMPK project representatives toenhance global ADME infrastructure, streamline reporting workflows,and improve timeline management. Partner with DMPK representativesto prepare and refine ADME sections of regulatory submissions,ensuring clarity, scientific rigor, and compliance with globalregulatory standards. Manage development ADME resources efficientlyto support global ADME objectives and optimize the balance betweeninternal and external capabilities. Develop tools and frameworks toenhance global collaboration, ensuring alignment and seamlesscommunication between Takeda’s global ADME teams (e.g., TBOS andTSHO). Education & Competencies (Technical and Behavioral):

Education Background Bachelor’s degree with 18 years of DMPKexperience, specializing in development ADME, with a primary focuson CRO management and direct CRO work; MS with 16 years ofexperience; or PhD with 10 years of experience. Technical Expertise10 years of hands-on experience in in vitro development ADME,including report writing for regulatory submissions. 10 yearsmanaging preclinical and clinical mass balance andbiotransformation studies, with a strong regulatory track record. 5years of direct regulatory submission experience for DMPK sections(IND, NDA, BLA) with a proven track record of success on multipleapproved small molecules and biologics. Advanced knowledge ofregulatory guidance for industry applicable to the design andanalysis of ADME studies. 5 years managing and conductingpreclinical PK/TK studies including NCA analysis and authoringcorresponding reports. 5 years of direct experience in regulatoryfiling with cross-functional interfaces including key partners suchas Research, Drug Safety, Clinical Development, Regulatory Affairs,and Medical Writings. Project and People Management 10 years ofproject management and coordination experience, demonstrating theability to drive complex initiatives to completion. 5 years ofpeople management experience including direct supervision of asubfunctional ADME or other DMPK teams. Analytical andCommunication Skills Strong analytical abilities to interpretcomplex 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 acollaborative and solution-oriented mindset. Innovation andContinuous Improvement Proven ability to lead innovationinitiatives to enhance efficiency, scalability, and impact ofinternal and external ADME and DMPK operations. Takeda Compensationand Benefits Summary We understand compensation is an importantfactor as you consider the next step in your career. We arecommitted to equitable pay for all employees, and we strive to bemore transparent with our pay practices.

For Location:

Boston, MAU.S.

Base Salary Range:

$174,500.00 – $274,230.00 The estimatedsalary range reflects an anticipated range for this position. Theactual base salary offered may depend on a variety of factors,including the qualifications of the individual applicant for theposition, years of relevant experience, specific and unique skills,level of education attained, certifications or other professionallicenses held, and the location in which the applicant lives and/orfrom which they will be performing the job.

The actual base salaryoffered will be in accordance with state or local minimum wagerequirements for the job location. U.S. based employees may beeligible for short-term and/or long-termincentives. U.S.basedemployees may be eligible to participate in medical, dental, visioninsurance, a 401(k) plan and company match, short-term andlong-term disability coverage, basic life insurance, a tuitionreimbursement program, paid volunteer time off, company holidays,and well-being benefits, among others. U.S.based employees are alsoeligible to receive, per calendar year, up to 80 hours of sicktime, and new hires are eligible to accrue up to 120 hours of paidvacation. EEO Statement Takeda is proud in its commitment tocreating a diverse workforce and providing equal employmentopportunities to all employees and applicants for employmentwithout regard to race, color, religion, sex, sexual orientation,gender identity, gender expression, parental status, nationalorigin, age, disability, citizenship status, genetic information orcharacteristics, marital status, status as a Vietnam era veteran,special disabled veteran, or other protected veteran in accordancewith applicable federal, state and local laws, and any othercharacteristic protected by law. Locations Boston, MA Worker TypeEmployee Worker Sub-Type Regular Time Type Full time Job Exempt YesIt is unlawful in Massachusetts to require or administer a liedetector test as a condition of employment or continued employment.

An employer who violates this law shall be subject to criminalpenalties and civil liability.