Senior Director, Drug Metabolism Pharmacokinetics & Modeling

Boston, Massachusetts

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Job Level: Senior
Travel: Minimal (if any)

At Takeda, we strive to provide transformational opportunities for every member of our team, and we empower our people to take charge of their futures. In an environment that fosters lifelong learning and a growth mindset, you’ll have the support you need to thrive — at work and beyond.

Job ID R0122792 Date posted 05/13/2024 Location Boston, Massachusetts

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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 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.

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:

205,100.00 - 322,300.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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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Where you fit in

Our team at Takeda is tackling some of the most challenging problems in drug discovery and development. As the newest member of our Research team, you’ll conduct purposeful, meaningful work on groundbreaking modalities that may lead to breakthrough drugs.

With our deep investment in next-generation technologies, you’ll have the resources and support to do your best work. As a part of our team, you’ll connect with brilliant minds inside and outside of Takeda. We are committed to collaborating with academia and emerging biotech companies to expand our reach and impact in cell therapy, gene therapy and data sciences.

Our team’s wide-ranging expertise includes medicinal chemistry, genomics datasets, immunofluorescence, high content imaging, flow cytometry, transcriptional profiling, multi-step synthesis, multimodal genetics, pharmacokinetics and much more. Whatever area inspires you, your work will support the progression of an innovative, industry-leading discovery pipeline and make an impact that matters to patients and society.

A career in Research at Takeda will give you everything you need to succeed professionally — and make a difference to patients, people and the planet.

Design and carry out experiments
Manage multiple projects
Document data
Mentor other scientists

Along with incredibly passionate colleagues, there’s a clear commitment to invest in the best facilities and the right equipment needed to successfully perform world-class science.

Christina Alves - Head of Biotherapeutics Process Development

I feel especially lucky to be able to work with colleagues across the industry to meet a unified goal.Takeda is paving the way for how research will be conducted in the future.

Daniel Scheibe - Senior Manager Operations, Systems Engineering, Drug Discovery Sciences

Our pipeline

Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.

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What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

Integrity
Fairness
Honesty
Perseverance

Working at Takeda

Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

We're Steadfast In Our Commitment to Four Key Imperatives

Patient

Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People

Create an exceptional people experience.

Planet

Protect our planet.

Data & Digital

Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

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