Executive Director, Pharmacometrics Head

Takeda•Boston, MA

2d•Hybrid

About The Position

Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver 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 to patients. The scientists (from pharmacometrics, quantitative clinical pharmacology, DMPK&M, Translational biomarkers and bioanalysis (TB&B), Imaging, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance) bring their expertise to our global program teams and reimagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence 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. 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. By being integrated into the AI eco-system, you will be constantly driving the advancement of the field and enabler of data and model-based decision making across all phases of drug development. Is a recognized expert internally and externally in the field of mechanistic modelling and more traditional pharmacometrics with demonstrated experience optimizing clinical drug development. Demonstrated expertise in applying MIDD principles to emerging data sources (RWD, natural history registries, omics data, HER data, etc.) to fully inform development programs. Explores and excels in synergistic relationships with experts and leaders in statistics, and other key data science disciplines driving and integrated approach. Provides additional portfolio support through program reviews, collaborative decision-making, infrastructure and best practice initiatives. Experience in applying quantitative approaches to evaluation of probability of technical success, including evaluating business development opportunities. Serves as an ambassador of Pharmacometrics, Quantitative Clinical Pharmacology (QCP), QPTS and DQS to the R&D organization and the external scientific community through high-value participation at scientific meetings and impactful publications.

Requirements

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.

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.

Benefits

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.

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