Senior Principal Scientist, Clinical Expert in Pharmacokinetics - all genders - #2646074

About the job

As Quantitative Pharmacology Project Expert within our Translational Medicine Unit, you’ll lead pharmacology programs supporting global R&D projects from research phase or in-licensing through registration. Ready to get started?

Based in Germany, you'll join our R&D organization where we leverage deep scientific expertise and cutting-edge pharmacology to advance our innovative pipeline. This position offers the opportunity to develop and monitor the execution of pharmacology strategies in global R&D projects.

Main responsibilities:

• Develop the strategy and monitor the execution of the Quantitative Pharmacology programs of the Translational Medicine Unit to support in-licensing, global research & development projects and the registration of products.


• Lead global Translational Medicine and/or Quantitative Pharmacology sub-teams. Monitor related activities, e.g., modelling & simulation, assay development, development of non-clinical and clinical study designs. Drive the selection of dose and dosing regimen, and de-risk the potential of drug-drug interactions.


• Development and/or review of protocols, analysis plans, and study reports; review and/or conduct of PK, PK/PD, population PK, population PK/PD, and/or PBPK analyses.


• Provide input to the preparation of regulatory documents and participate in interactions with health authority at key milestones.

About you

Experience:

• Experience in pharmaceutical development.


• Experience with regulatory interactions (especially FDA and EMA) and submissions.


• Experience in pharmacokinetic/statistical analysis of clinical data with common software packages (e.g. Phoenix).


• Experience in software for physiology-based PK modelling (preferably PK-Sim or SimCyp), and population modeling for analyzing PK/PD data (NonMem, R) would be of advantage.

Education:

• PhD in pharmacokinetics, pharmacometrics, clinical pharmacology, or other suitable post-graduate qualifications.

Languages:

• Fluency in English required.

Why choose us?

• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.


• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.


• Help improve the lives of millions of people globally by making drug development quicker and more effective.


• Enjoy opportunities to collaborate beyond your area of expertise, working with diverse teams across science, clinical, and digital fields to spark new ideas and drive breakthroughs.


• Accelerate your professional development with structured career paths designed for both scientific and leadership advancement. Grow in ways you never imagined through bold moves that stretch your potential, cross moves into other business areas, and short-term gigs that build your scientific expertise.


• Enjoy outstanding benefits, including flexible working options, comprehensive healthcare, and well-being programs designed to help you thrive.

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