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Clinical Pharmacometrician

Ort Gaithersburg, Maryland, USA Waltham, Massachusetts, USA Anzeigen-ID R-151175 Veröffentlichungsdatum 27/10/2022

Associate Director, Clinical Pharmacometrician

This is a scientific job with responsibility for pharmacometrics (PMx) activities including population PK, PKPD, exposure-response, disease modelling, and simulations in all clinical development phases. With support from the Post Market and Lifecycle Management Group Director and the Therapy Area Head, the incumbent will be responsible for integrating and analysing internal and external data to support interpretation and decision making at both study level and project level.

The individual will drive the application of foundational and cutting-edge pharmacometrics techniques, in combination with business domain knowledge, to develop and apply advanced modelling to generate business and scientific insights. They coordinate the creation, maintenance and/or improvement of advanced pharmacometric models for ongoing and ad hoc review and analysis. The individual will provide coaching, task management and support to junior staff and promote best practice across multiple domains, and/or stakeholder groups.

Responsibilities:

  • Accountable for expert data integration, analysis, interpretation, and reporting of M&S results at the study level

  • Accountable for executing state-of-the-art M&S techniques with direct value for the project

  • Use of M&S to influence study designs and go/no go decisions

  • Development of drug-disease models to support projects within a specific disease domain

  • Contribute to regulatory documents and interactions (written)

  • Presentation of M&S results in internal and external forum

  • Contribute to internal initiatives to develop the pharmacometrics discipline including its processes

  • Participation in peer review of ongoing activities, reports and presentations

  • Compliance with Good Clinical Practice (GCP) regulations as well as internal/external guidance’s

Requirement

  • Demonstrated expertise in pharmacometrics, including PK, PK/PD and/or statistics

  • Strong quantitative skills (e.g. experience in population modelling, statistics, systems and translational pharmacology modelling).

  • Expert knowledge of pharmacokinetics and Model-Informed Drug Development (MIDD)

  • Demonstrated broad translational and clinical development expertise and experience exemplified by 3-6 Years of drug development experience, with emphasis on Clinical Pharmacometrics

  • Demonstrated ability to identify, develop and execute Pharmacometrics activities at a project level

  • Good oral and written communication skills

  • Good knowledge of global regulatory, compliance, processes, standards and issues specific to clinical pharmacology

  • PhD degree preferred or equivalent (M.Sc./Pharm.D.) with relevant experience required

  • Relevant regulatory experience (written)

  • Training and experience with PK, pharmacometric and statistical software (R, nonmem, monolix, nlmixr, stan, winbugs, phoenix/nlme)

Desirable

  • Scientific publishing in the field on pharmacometrics

  • Early or late phase clinical development experience/awareness

  • Knowledge in pharmacology, drug targets and core disease areas



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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