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Principal Scientist, Toxicology(m/w/x)
Designing nonclinical safety strategies for biotherapeutic drug development. 5-8 years pharma/biotech experience with GLP and regulatory submissions required. 4-week workation option.
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
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
Work Experience
- 5 - 8 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
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Principal Scientist, Toxicology(m/w/x)
Designing nonclinical safety strategies for biotherapeutic drug development. 5-8 years pharma/biotech experience with GLP and regulatory submissions required. 4-week workation option.
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
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
Work Experience
- 5 - 8 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
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.
Not a perfect match?
- CSL Plasma
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Principal Scientist, Regulatory Toxicology(m/w/x)
Full-timeOn-siteSeniorGlattbrugg - CSL Behring
Senior Scientist, Regulatory Toxicology(m/w/x)
Full-timeOn-siteSeniorOpfikon - CSL Behring
Principal Scientist, Pharmacokinetics (PK)(m/w/x)
Full-timeOn-siteSeniorGlattbrugg - CSL Behring
Senior Scientist, Pharmacokinetics (PK)(m/w/x)
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