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TakedaPharmaceutical Nordics AB · 22 hours ago

Executive Director, Pharmacometrics Head

Boston, MA

Full-time

Hybrid

Director/Executive

$208K/yr - $327K/yr

15+ years exp

TakedaPharmaceutical Nordics AB is a leading biopharmaceutical company committed to discovering and 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 automation and AI in pharmacometrics to enhance drug development processes.

Pharmaceuticals

Responsibilities

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 the field of mechanistic modelling and more 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 driving and integrated approach

Provides additional portfolio support through program reviews, collaborative decision-making, infrastructure and best practice initiatives

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

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

PharmacometricsMechanistic modellingStatisticsAIAutomationQuantitative analysisTeam mobilizationLeadershipCommunicationOrganizational skillsNegotiation skills

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