Takeda · 1 day ago
Executive Director, Pharmacometrics Head
Takeda is a global, values-based biopharmaceutical leader committed to delivering life-transforming treatments. The Executive Director, Pharmacometrics Head will strategically lead the implementation of model-informed drug development strategies and drive the use of AI in pharmacometrics to enhance drug development processes.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
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, defines, leads and drives cross therapeutic area and platform level pharmacometrics strategies with the aim of driving the advancement of the Takeda portfolio through various decision-making milestones. Seeks opportunities to extend MIDD based approaches beyond drug development to decisions impacting product valuation and reimbursement
Leads and Drives the evolution of our in-house modelling platform capabilities with a vision of increased automation, integration of emerging data sources in addition to program-level clinical trial data, and use of AI with an end-to-end mindset and process, in compliance with GxP
Works with colleagues in DMPK&M to enable the transition and implementation of mechanistic modelling and thinking (PK-PD, PBPK-PD, QSP) into the clinical portfolio as an assets progress through IND, with the aim of enriching our understanding and potential opportunities, populations, dosing, trial design optimization
Key driver of pharmacometrics strategies, including Model-Informed Drug Development (MIDD) as part of the overall QDM framework integrating pharmacometrics plan in collaboration with QCP and SQS
Represents Pharmacometrics, where required in global or regional regulatory agency meetings and be 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, and provides fir-for-purpose evidence based risk assessments to the team in a timely manner
Promotes and drives the Pharmacometrics vision and mission, identifying opportunities and creates delivery for DQS mission to make R&D business impact
Seen as a role model to member of QCP and DQS
Acts as a cross functional and collaborative leader
Demonstrates leadership in scientific societies and cross-industry consortiums related to the pharmacometrics work streams within ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, and DIA
Qualification
Required
Pharm D. or PhD with 15+ years of working experience in a quantitative field with extensive in pharmacometrics, mechanistic modelling, statistics or chemical bio-engineering with extensive management and leadership experience
MS with 18+ years' working experience in a quantitative field with extensive experience in pharmacometrics, mechanistic modelling, statistics or chemical bio-engineering with extensive management and leadership experience
Established Subject Matter Expert in multiple areas internally or externally including leadership of one or more internal or external focus groups
Robust understanding of pharmacology and statistical principles
Recognized expert internally and externally in the area of pharmacometrics and clinical pharmacology and its criticality in all stages of drug development. Demonstrated passion for innovative applications and technologies, including AI and automation
Defines and leads a cross-therapeutic strategy, directing and overseeing complex pharmacometrics analyses including developing innovative methodology/ in close partnership with other DQS functions and other internal and/or external partners
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 significant understanding of R&D cross functional strategy from candidate selection through life-cycle management
Significant experience in HA interactions and submissions
Extensive experience in the implementation of MIDD strategies as part of global filings and approvals
Drives for efficiency and cost effectiveness in drug development plan by implementation of a robust pharmacometrics plan to optimize trial design, sample size, decisions, timepoints of assessment using innovative processes and methodologies or by building internal capabilities
Ability to evaluate benefit-risk associated with project/asset/franchise and TAU decisions and effectively manage GPT expectations
The ability to establish external networks to facilitate collaborations across industry, government, and academia
Provides strong scientific and strategic leadership
Experienced people manager/leader
Strong organizational skills in terms of process and resources
Good communicator on an inter-personal basis as well as in an audience
Mobilizes high performance teams
Influences beyond QPTS and DQS
Effective communication including influencing others, negotiation skills, and able to manage conflicts in matrix cross-functional teams
Prioritizes and delegates
Energizes the organization and prepares for the future
Benefits
U.S. based employees may be eligible for short-term and/ or long-term incentives.
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.
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Recent News
2026-01-09
2026-01-08
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