Senior Principal Scientist - Pharmacometrics

THE POSITION

Are you passionate about applying your pharmacometric skills, strategic thinking, and practical experience in data science? Would you like to join cross-functional clinical development teams, and do you feel like expanding your influence and deepening your knowledge in data science approaches beyond pharmacometrics?

You will also have the exciting prospect of acting as the pharmacometrics lead (PMx lead) in our clinical development project teams to fulfill our vision of turning data into knowledge. As PMx lead, you'll have the chance to shape and contribute to projects already prior to first-in-man clinical trials.

This position can be filled in Ingelheim or Biberach.

Tasks & responsibilities

• As a Senior Principal Scientist in Pharmacometrics, you will develop the pharmacometric strategy and identify opportunities where pharmacometrics and other advanced data analytic approaches can further the understanding of pharmacological activity, efficacy and safety of a drug.
• You will join cross-functional clinical development teams as the PMx lead where you work in close alignment with other team members and data science subject matter experts and are responsible for the PMx data and data analysis strategy and advising clinical development teams on opportunities and limitations of pharmacometrics approaches.
• You will be responsible for complex clinical development projects up to submission representing pharmacometrics at important regulatory meetings such as advisory boards.
• Furthermore, you will be responsible for the planning and execution of relevant pharmacometric analyses to support internal decision making, disease understanding and successful approval.
• 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., clinical development plans).
• Moreover, you will continuously evaluate or develop, implement, and promote innovative pharmacometric methodologies, approaches, (software) tools and related business processes.
• You will provide consultancy and expert advice for other scientists and stakeholders across therapeutic areas as an internally and externally recognized scientist.
• You will lead and/or contribute to internal and external initiatives/working groups (e.g. focus groups in your therapeutic area of expertise, across department initiatives, process harmonization, IMI calls, ISoP groups, Open Systems Pharmacology), organize and manage projects with external organizations and establish and maintain contacts to key opinion leaders in the field of pharmacometrics and data science in general.

Requirements

We expect a strong team player, who is able to successfully act in a global and remote context. Good interpersonal skills with the ability to effectively interact internally as well as externally and the ability to pro-actively identify issues and provide solutions are a pre-requisite.

• PhD. or master's degree in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics or relevant area of focus
• Long-standing experience in Pharmacometrics/Data Science in the pharmaceutical industry, regulatory agencies, CRO or academia with relevant experience in working in clinical development teams
• Comprehensive 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)
• In-depth knowledge in other data science fields, clinical pharmacology, clinical drug development, MID3, and regulatory guidelines

Ready to contact us?

If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330 or via mail: hr.de@boehringer-ingelheim.com

Unser Unternehmen

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