7 дней назад
Senior Principal Scientist, Clinical Expert in Pharmacokinetics
88 800 - 118 400€
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Principal Scientist, Clinical Expert in Pharmacokinetics (Quantitative Pharmacology): Developing and monitoring pharmacology strategies for global R&D projects from research and in-licensing through product registration with an accent on PK, PK/PD, population PK, and PBPK analyses. Focus on leading Translational Medicine sub-teams, selecting doses and dosing regimens, de-risking drug-drug interactions, and supporting regulatory interactions with the FDA and EMA.
Location: Frankfurt am Main, Germany; hybrid working
Salary: €88,800–€118,400 per year
Company
is a biopharmaceutical company developing medicines through patient-informed research, advanced pharmacology, AI, data, and digital platforms.
What you will do
- Develop quantitative pharmacology strategies supporting in-licensing, global R&D projects, and product registration.
- Lead global Translational Medicine and Quantitative Pharmacology sub-teams and monitor program execution.
- Coordinate modelling and simulation, assay development, and non-clinical and clinical study design activities.
- Drive dose and dosing-regimen selection and assess potential drug-drug interactions.
- Develop or review protocols, analysis plans, and study reports.
- Conduct or review PK, PK/PD, population PK, population PK/PD, and PBPK analyses and contribute to regulatory documents and health-authority interactions.
Requirements
- PhD in pharmacokinetics, pharmacometrics, clinical pharmacology, or a suitable postgraduate discipline.
- Experience in pharmaceutical development and regulatory interactions, particularly with the FDA and EMA.
- Experience analyzing clinical pharmacokinetic and statistical data with common software packages such as Phoenix.
- Fluency in English is required.
Nice to have
- Experience with physiology-based PK modelling software such as PK-Sim or SimCyp.
- Experience with population modelling of PK/PD data using NonMem or R.
Culture & Benefits
- Collaboration across scientific, clinical, and digital disciplines.
- Flexible working options, comprehensive healthcare, and well-being programs.
- Structured career paths supporting scientific and leadership development.
- Opportunities to contribute to innovative drug discovery and patient-informed study design.
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