Senior / Principal Scientist Pharmacometrics

The Position

Tasks and responsibilities

• In your new role, you will develop the pharmacometric strategy and identify opportunities where pharmacometrics approaches can further the understanding of pharmacological activity, efficacy and safety of a drug.
• Furthermore, you will join cross-functional clinical development teams as the PMx lead, where you work in close alignment with other team members and are responsible for the PMx data and data analysis strategy and advising clinical development teams on opportunities and limitations of MIDD approaches.
• You will be responsible for the planning and execution of relevant pharmacometric analyses to support internal decision making, disease understanding and successful approval.
• Moreover, you will ensure the timely delivery of analysis-related documentation (e.g., dataset specification, analysis plans, and reports) and documents where you are co-author (e.g., asset evidence plan, pediatric investigational plan, submission documents).
• You will organize and manage projects with external organizations such as CROs or academic institutions.
• In addition, you will also represent TMCP Clinical Pharmacology/PMx in internal and external initiatives/working groups such as focus groups in your therapeutic area of expertise, across department initiatives, process harmonization, IMI calls, ISoP groups, Open Systems Pharmacology.
• You will continuously evaluate and implement novel pharmacometric approaches and may support or drive the development of quantitative methodological approaches, pharmacometrics (software) tools, and related business processes.

Requirements

• PhD, MD or master’s degree from an accredited institution in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics or relevant area of focus with multi-years of relevant experience in Pharmacometrics in the pharmaceutical industry, CROs, regulatory agencies, or academia
• Several years of relevant experience in working in clinical development teams
• Solid knowledge in applying PMx software (e.g., NONMEM, Monolix, R, PBPK software) and approaches (e.g. population pharmacokinetics, pharmacokinetics/pharmacodynamics, exposure response, disease progression modeling, model-based meta-analysis as well as PBPK)
• Broad knowledge in applying PMx software and approaches as well as broad knowledge in other data science fields, clinical pharmacology, clinical drug development, MID3, and regulatory guidelines
• Strong team player, who is able to successfully act in the global context
• Good interpersonal skills with the ability to interact effectively with people, internally and externally
Ability to pro-actively identify issues and solutions

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