Principal Scientist / Senior Principal Scientist

Jobtailor; Biberach an der Riß; Vor Ort; EUR 120.000 - 180.000; Vollzeit

Zusammenfassung

Jobtailor is seeking a Senior Principal Scientist to lead the global genotoxicity strategy, overseeing in silico mutagenicity assessments and derisking across development stages.

You will coordinate with international stakeholders, contribute to regulatory submissions, and represent scientific positions in health authority interactions, shaping best practices in genetic toxicology.

Qualifikationen

• PhD or Master in a relevant scientific field with professional experience.
• Strong knowledge of mutagenicity, structural reactivity and genetic toxicology.
• Experience in in silico mutagenicity prediction and related assays.
• Experience in literature research and use of scientific databases.
• Knowledge of pharmaceutical development and genetic toxicology in drug development.
• Ability to coordinate multiple stakeholders and communicate findings in German and English.
• Expertise in coordinating cross-functional global stakeholders.

Aufgaben

• Coordinate in silico assessments of mutagenicity and derisking strategies across project stages.
• Prepare scientific reports and provide expert judgment on findings.
• Contribute to regulatory submission documents and regulatory interactions.
• Advise R&D teams on mutagenic impurities, metabolites, and exposure limits.
• Represent scientific results in international project teams and health authority discussions.

Kenntnisse

In Silico Mutagenicity Prediction

Genetic Toxicology

Regulatory Submission Experience

Stakeholder Coordination

Literature Research

Ausbildung

PhD in Chemistry/Biology/Biochemistry or comparable degree, or Masters in Biology/Computer Science

Tools

Scientific Databases

Relevant Software Tools

Jobbeschreibung

• 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