Executive Director, Pharmacometrics Head

Executive Director, Pharmacometrics Head 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, people, and the planet.

Our Data and Quantitative Sciences Department (DQS) comprises more than 700 quantitative scientists who harness data to accelerate the development of highly innovative treatments. The Pharmacometrics team, part of DQS and Quantitative Pharmacology and Translational Science (QPTS), drives, implements, and executes a model‑informed drug development (MIDD) strategy for each asset from pre‑FIH through life‑cycle management within the global project team.

• Strategically lead and implement model‑informed drug development strategies across early and late‑phase clinical portfolios, enabling 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).
• Drive the implementation of automation and AI in pharmacometrics (E2E) to increase capacity, quality, and timeline efficiencies, continuously advancing the field and enabling data‑ and model‑based decision making across all phases of drug development.
• Serve as a recognized expert internally and externally in mechanistic modelling and traditional pharmacometrics, demonstrating experience optimizing clinical drug development and applying MIDD principles to emerging data sources (RWD, natural history registries, omics data, HER data, etc.).
• Explore and excel in synergistic relationships with experts in statistics and other data science disciplines, driving an integrated approach.
• Provide portfolio support through program reviews, collaborative decision making, and best‑practice initiatives, including evaluating probability of technical success and business development opportunities.
• Act as an ambassador of Pharmacometrics, Quantitative Clinical Pharmacology (QCP), QPTS, and DQS to the R&D organization and the external scientific community through scientific meetings and impactful publications.

• Lead and manage a team of in‑house pharmacometricians to deliver all analyses internally and externally supporting the Takeda clinical portfolio and business development activities.
• Maintain relationships with external vendors to support regulatory pharmacometrics analyses.
• Operate at an enterprise level, defining, leading, and driving cross‑therapeutic area and platform‑level pharmacometrics strategies that advance the Takeda portfolio through decision‑making milestones, including product valuation and reimbursement.
• Lead the evolution of our in‑house modelling platform, envisioning increased automation, integration of emerging data sources, and AI with an end‑to‑end mindset, complying with GxP.
• Collaborate with DMPK&M to transition and implement mechanistic modelling and thinking (PK‑PD, PBPK‑PD, QSP) into the clinical portfolio as assets progress through IND, enriching understanding and informing opportunities, populations, dosing, and trial design.
• Drive pharmacometrics strategies, including MIDD, as part of the overall QDM framework, coordinating with QCP and SQS.
• Represent Pharmacometrics in regulatory agency meetings and produce the technical components of clinical pharmacology summary documents for regulatory submissions.
• Maintain high standards for good clinical practice, compliance, and ethics.
• Participate in business development due diligence, providing evidence‑based risk assessments.
• Promote and advance the Pharmacometrics vision and mission, creating delivery for the DQS mission to impact R&D business.
• Serve as a role model for QCP and DQS members and act as a cross‑functional collaborative leader.
• Demonstrate leadership in scientific societies and cross‑industry consortiums related to pharmacometrics (ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, DIA).

• Pharm D or PhD with 15+ years of quantitative experience, including extensive pharmacometrics, mechanistic modelling, statistics, or chemical…