Principal Scientist / Senior Principal Scientist

• Coordinate, evaluate, and conduct in silico assessments to predict mutagenicity in accordance with ICH M7
• Scientifically evaluate related literature searches
• Develop and support derisking strategies for mutagenic impurities and metabolites across project development stages
• Prepare scientific reports, including expert judgment on the relevance of findings
• Contribute to regulatory submission documents
• Advise Research & Development teams on mutagenic impurities, mutagenic metabolites, and acceptable exposure limits for mutagenic carcinogens
• Represent scientific results and recommendations in international project teams
• Discuss implications and support informed risk-based decision-making
• Independently manage and respond to health authority inquiries related to ICH M7 topics
• Coordinate global project requirements and ensure compliance with regulatory expectations and internal procedures
• Senior Principal Scientist: lead implementation and further development of the global genotoxicity strategy
• Senior Principal Scientist: lead complex and time-critical issues with significant regulatory impact
• Senior Principal Scientist: provide recommendations to international stakeholders
• Senior Principal Scientist: contribute to scientific committees and expert forums, foster scientific exchange, and advance scientific standards and best practices

Requirements

• 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, including relevant software tools, derisking strategies, and associated genetic toxicology assays
• Experience in literature research and the use of scientific databases
• Knowledge of pharmaceutical development and the application of genetic toxicology principles in a drug development environment
• Ability to coordinate multiple stakeholders, work effectively under pressure, and communicate complex scientific findings in German and English
• Senior Principal Scientist: extensive experience in applying and interpreting in silico mutagenicity assessments within pharmaceutical development
• Senior Principal Scientist: demonstrated capability to lead complex scientific topics and coordinate cross-functional global stakeholders
• Senior Principal Scientist: experience representing scientific positions in interactions with health authorities, scientific committees, or expert forums

Core Competencies

Demonstrates expertise in in silico mutagenicity prediction and genetic toxicology, with a strong ability to coordinate global project requirements and communicate complex scientific findings in both German and English. Proven leadership in managing cross-functional teams and contributing to regulatory submissions and scientific committees.

Highest-signal resume keywords

• In Silico Mutagenicity Prediction
• Genetic Toxicology
• Regulatory Submission Experience
• Stakeholder Coordination
• Literature Research

Hard Skills

• Mutagenicity Assessment
• Structural Reactivity
• Genetic Toxicology Assays
• Pharmaceutical Development
• Derisking Strategies

Soft Skills

• Effective Communication
• Leadership
• Decision-Making
• Collaboration
• Pressure Management

Industry Keywords

• ICH M7
• Health Authority Inquiries
• Scientific Committees
• Expert Forums
• Drug Development Environment

Tools & Technologies

• Scientific Databases
• Relevant Software Tools