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Principal Scientist, Toxicology(m/w/x)
Description
As a Principal Scientist in Toxicology, you will lead nonclinical safety strategies for drug development, collaborate with cross-functional teams, and ensure compliance with regulatory standards while managing safety risks throughout the process.
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Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •PhD, DVM, or equivalent in Toxicology, Pharmacology, or related field
- •5-8 years of experience in pharmaceutical or biotech industry
- •Proven track record in nonclinical safety assessment and regulatory submissions
- •Strong understanding of GLP regulations, ICH guidelines, and global regulatory requirements
- •Excellent communication, leadership, and cross-functional collaboration skills
- •Experience with CSL’s disease therapeutic areas
- •Experience across multiple therapeutic areas and modalities
Education
Work Experience
5 - 8 years
Tasks
- •Lead and manage nonclinical safety strategies for drug development projects
- •Serve as the primary toxicology representative on interdisciplinary project teams
- •Lead the Nonclinical Expert Team (NCET)
- •Provide scientific leadership from early discovery to regulatory submission
- •Design and monitor nonclinical safety studies in GLP and non-GLP environments
- •Compile toxicological risk assessments for drug development projects
- •Prepare and review regulatory nonclinical submission documents
- •Collaborate with pharmacology, PK, clinical, regulatory, and CMC teams
- •Present integrated safety assessments to senior management
- •Identify and manage safety risks early in development
- •Compile risk assessments for impurities, extractables, leachables, and excipients
- •Stay updated on toxicology guidelines and risk assessment methodologies
Languages
English – Business Fluent
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Principal Scientist, Toxicology(m/w/x)
The AI Job Search Engine
Description
As a Principal Scientist in Toxicology, you will lead nonclinical safety strategies for drug development, collaborate with cross-functional teams, and ensure compliance with regulatory standards while managing safety risks throughout the process.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •PhD, DVM, or equivalent in Toxicology, Pharmacology, or related field
- •5-8 years of experience in pharmaceutical or biotech industry
- •Proven track record in nonclinical safety assessment and regulatory submissions
- •Strong understanding of GLP regulations, ICH guidelines, and global regulatory requirements
- •Excellent communication, leadership, and cross-functional collaboration skills
- •Experience with CSL’s disease therapeutic areas
- •Experience across multiple therapeutic areas and modalities
Education
Work Experience
5 - 8 years
Tasks
- •Lead and manage nonclinical safety strategies for drug development projects
- •Serve as the primary toxicology representative on interdisciplinary project teams
- •Lead the Nonclinical Expert Team (NCET)
- •Provide scientific leadership from early discovery to regulatory submission
- •Design and monitor nonclinical safety studies in GLP and non-GLP environments
- •Compile toxicological risk assessments for drug development projects
- •Prepare and review regulatory nonclinical submission documents
- •Collaborate with pharmacology, PK, clinical, regulatory, and CMC teams
- •Present integrated safety assessments to senior management
- •Identify and manage safety risks early in development
- •Compile risk assessments for impurities, extractables, leachables, and excipients
- •Stay updated on toxicology guidelines and risk assessment methodologies
Languages
English – Business Fluent
About the Company
CSL Behring
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein globaler Marktführer in der Biotherapeutik, der innovative Therapien für Patienten mit immunologischen, hämatologischen, kardiovaskulären und anderen Erkrankungen entwickelt.
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Principal Biostatistician(m/w/x)
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Sr. Dir., Global Regulatory Team Leader – Hematology & LCM Europe(m/w/x)
Full-timeOn-siteSeniorGlattbrugg