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Company

Takeda · 5 hours ago

Associate Director, Pharmacometrics Lead

United States

Full-time

Remote

Director/Executive

8+ years exp

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BiotechnologyHealth Care

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Hiring Manager

Rania E.

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Responsibilities

Explores and excels in synergistic relationships with experts in clinical pharmacology, digital health, global outcomes/epidemiology, biostatistics, and other key data science disciplines.

Serves as an ambassador of Quantitative Clinical Pharmacology/Pharmacometrics (QCP/Pmx) and Data Sciences Institute (DSI) to the R&D organization and the external scientific community through high-value participation at scientific meetings and impactful publications.

Provides scientific and strategic pharmacometric leadership for multiple projects on Global Program Teams and associated scientific and operational sub-teams with limited supervision.

Independently drives and leads the formulating and delivery of the pharmacometrics component of the QP Plan.

Key contributor and driver of pharmacometrics strategies, including Model-Informed Drug Development (MIDD) practices and advanced modeling and simulation approaches (e.g., QSP, MBMA, CTS) to inform internal decisions and external regulatory interactions.

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.

Oversees and/or independently performs PK, PD, and pharmacometric analyses including the interpretation of PK/PD data in close partnership with DSI and external partners.

Maintains a high standard for good clinical practice, compliance, and ethics.

Mentors junior staff to promote scientific excellence and individual achievement.

Participates as a member of Business Development due diligence, when requested.

Contributes to infrastructure initiatives and/ or cross-functional best practice initiatives.

Has scientific influence outside QCP and Takeda through presentations and publications and active contribution to scientific societies and cross-industry consortiums related to pharmacometrics such as working groups or sessions at ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, and DIA.

Qualification

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PharmacometricsMechanistic modellingStatisticsChemical bio-engineeringRNonMemSTANSASPhoenixMathematical backgroundStatistical backgroundGlobal regulatory expectationsDrug developmentPK/PD analysisBusiness understandingCollaborative mindset

Required

Pharm D. or PhD with 5+ years of working experience in a quantitative field with working experience in pharmacometrics, mechanistic modelling, statistics or chemical bio-engineering OR MS with 8+ years' working experience in a quantitative field working experience in pharmacometrics and/or mechanistic modelling.

Established skills in pharmacometrics and its application in early & late stage drug development programs.

Able to oversee the technical aspects of out-sourced pharmacometrics work in collaboration with the QCP lead.

Expert in use of some of the relevant software e.g. R, NonMem, STAN, SAS, Pheonix.

Solid mathematical and/or statistical background.

Able to communicate results at both a technical and strategic level to non-experts.

Comprehensive understanding of global regulatory expectations, stages of drug development and opportunities of the application of pharmacometrics within the drug development paradigm.

Expert knowledge of regulatory guidance for industry applicable to pharmacometrics.

Advanced knowledge and/or hands-on applications in integration of PK, PD, efficacy, and safety data from multiple sources for dose selection and decision-making.

Independently works by delivering, and prioritizing QCP/Pmx activities across projects with minimal supervision.

Effectively drives and influences project teams towards objectives while enabling and making decisions.

Focuses on priorities and delivers on commitments.

Strong communication skills and ability to translate effectively across functional lines.

Possess collaborative mindset, inspire teamwork, and is effective at building alliance across functions.

Assess benefit/risk of options.

Develop understanding of business beyond QCP/Pharmacometrics.