Dein persönlicher KI-Karriere-Agent
Principal Scientist / Senior Principal Scientist (m/w/x)
In silico mutagenicity assessments for global drug development projects. Expertise in prediction software and derisking strategies required. Comprehensive benefits and wellbeing package.
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Anforderungen
- PhD in Chemistry, Biology, Biochemistry, or comparable scientific degree with relevant professional experience, or Master's degree in Biology or Computer Science
- Solid knowledge of mutagenicity, structural reactivity, and genetic toxicology
- Expertise in in silico mutagenicity prediction, software tools, derisking strategies, and genetic toxicology assays
- Experience in literature research and scientific databases
- Knowledge of pharmaceutical development and genetic toxicology principles in drug development
- Ability to coordinate stakeholders, work under pressure, and communicate scientific findings in German and English
- Extensive experience in applying and interpreting in silico mutagenicity assessments in pharmaceutical development
- Capability to lead complex scientific topics and coordinate cross-functional global stakeholders
- Experience representing scientific positions to health authorities, scientific committees, or expert forums
Aufgaben
- Assess mutagenic risks
- Support global development projects
- Influence development and regulatory decisions
- Coordinate, evaluate, and conduct in silico mutagenicity assessments (ICH M7), including literature searches
- Develop and support derisking strategies for mutagenic impurities and metabolites
- Prepare scientific reports with expert judgment
- Contribute to regulatory submission documents
- Advise R&D teams on mutagenic impurities, metabolites, and exposure limits
- Represent scientific results and recommendations in international project teams
- Discuss implications of scientific results
- Support informed risk-based decision-making
- Manage and respond to health authority inquiries (ICH M7)
- Coordinate global project requirements
- Ensure compliance with regulations and procedures
- Lead global genotoxicity strategy implementation and development
- Lead complex, time-critical issues with regulatory impact
- Provide recommendations to international stakeholders
- Contribute to scientific committees and expert forums
- Foster scientific exchange
- Drive advancement of scientific standards and best practices
Berufserfahrung
Ausbildung
Sprachen
Tools & Technologien
Benefits
- Comprehensive benefits and wellbeing package
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