Job Description
Takeda is a global, values‑based, R&D‑driven, top 10 biopharmaceutical leader committed to discovering and delivering life‑transforming treatments, guided by our commitment to patients, our people, and the planet.
Our Data and Quantitative Sciences Department (DQS) is made up of more than 700 quantitative scientists who harness the insight of data to speed the development of highly innovative treatments. The scientists—ranging from pharmacometrics, quantitative clinical pharmacology, DMPK&M, translational biomarkers and bioanalysis (TB&B), imaging, statistics, programming, outcomes research and epidemiology, to patient safety & pharmacovigilance—bring their expertise to global program teams and reimagine our disciplines. They work with novel data streams, including real‑world data and digital tools, and apply advanced analytics such as AI and automation.
As part of DQS and Quantitative Pharmacology and Translational Science (QPTS), the Pharmacometrics team is a therapeutically agnostic team driving, implementing, and executing an MIDD strategy for each asset from pre‑FIH through life‑cycle management within the global project team.
Position Objectives
- Strategically leads and drives the implementation of model‑informed drug development strategies across the early and late‑phase clinical portfolio to enable robust dose/regimen recommendations, trial designs, and go‑no‑go decisions through the life‑cycle of our products in collaboration with other functions (e.g., QCP, SQS, GEO).
- Drives the implementation of automation and the use of AI in the discipline of pharmacometrics (E2E) to enable increased capacity, quality, and timeline efficiencies.
- Is a recognized expert internally and externally in mechanistic modelling and traditional pharmacometrics with demonstrated experience optimizing clinical drug development.
- Explores and excels in synergistic relationships with experts and leaders in statistics and other key data science disciplines to drive an integrated approach.
- Provides additional portfolio support through program reviews, collaborative decision‑making, infrastructure, and best practice initiatives.
- Serves as an ambassador of Pharmacometrics, QCP, QPTS, and DQS to the R&D organization and the external scientific community through high‑value participation at scientific meetings and impactful publications.
Accountabilities
- Leads and drives a team of in‑house pharmacometricians to deliver all pharmacometrics analyses internally and externally to support the Takeda clinical portfolio and business‑development activities.
- Maintains a network and strong relationship with external vendors to support regulatory pharmacometrics analyses.
- Operates at an enterprise level, defining, leading, and driving cross‑therapeutic area and platform‑level pharmacometrics strategies.
- Leads the evolution of our in‑house modelling platform capabilities with a vision of increased automation, integration of emerging data sources, and use of AI in compliance with GxP.
- Works with colleagues in DMPK&M to enable the transition and implementation of mechanistic modelling (PK‑PD, PBPK‑PD, QSP) into the clinical portfolio as assets progress through IND.
- Key driver of pharmacometrics strategies, including Model‑Informed Drug Development (MIDD) as part of the overall QDM framework.
- Represents Pharmacometrics at global or regional regulatory agency meetings and is responsible for the technical component of the clinical pharmacology summary documents for regulatory submissions.
- Maintains a high standard for good clinical practice, compliance, and ethics.
- Participates as a member of business‑development due diligence, providing evidence‑based risk assessments to the team in a timely manner.
- Promotes and drives the Pharmacometrics vision and mission, identifying opportunities and creating delivery for DQS mission to make R&D business impact.
- Acts as a cross‑functional and collaborative leader.
- Demonstrates leadership in scientific societies and cross‑industry consortiums related to the pharmacometrics work streams.
Education & Competencies (Technical and Behavioral)
- Pharm D. or PhD with 15+ years of experience in a quantitative field, extensive pharmacometrics, mechanistic modelling, statistics, or chemical bio‑engineering, and substantial management and leadership experience.
- MS with 18+ years of experience in a quantitative field, extensive pharmacometrics, mechanistic modelling, statistics, or chemical bio‑engineering, and extensive management and leadership experience.
Desired Technical Skills
- Subject matter expert in multiple areas internally or externally, including leadership of one or more focus groups.
- Robust understanding of pharmacology and statistical principles.
- Recognized expert in pharmacometrics and clinical pharmacology with a passion for innovative applications and technologies, including AI and automation.
- Defines and leads a cross‑therapeutic strategy, directing and overseeing complex pharmacometrics analyses.
- Drives innovative strategies and influences business‑critical decision‑making beyond QCP/Pharmacometrics responsibilities.
- Solid mathematical and pharmacological/mechanistic background and training.
- Experienced drug developer with a comprehensive understanding of R&D cross‑functional strategy from candidate selection through life‑cycle management.
- Significant experience in HA interactions and submissions.
- Extensive experience in implementing MIDD strategies for global filings and approvals.
- Drives efficiency and cost‑effectiveness by implementing robust pharmacometrics plans to optimize trial design, sample size, and assessment timepoints.
- Ability to evaluate benefit‑risk associated with project/asset/TAU decisions and manage expectations.
- Ability to establish external networks to facilitate collaborations across industry, government, and academia.
Desired Behavioral Competencies
- Provides strong scientific and strategic leadership.
- Experienced people manager/leader.
- Strong organizational skills in terms of process and resources.
- Effective communicator on an interpersonal basis and to audiences.
- Mobilizes high‑performance teams.
- Influences beyond QPTS and DQS.
- Manages conflicts and negotiations in matrix cross‑functional teams.
- Prioritizes and delegates.
- Energizes the organization and prepares for the future.
More About Us
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best‑in‑class patient support programs. Takeda is a patient‑focused company that will inspire and empower you to grow through life‑changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy.
Compensation and Benefits Summary
Location: Boston, MA
U.S. Base Salary Range: $208,200.00 – $327,140.00
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‑term incentives, 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.
Employment Details
Locations: Boston, MA
Worker Type: Employee
Worker Sub‑Type: Regular
Time Type: Full time
Job Exempt: Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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