PSI CRO
Clinical Research Associate / Senior Clinical Research Associate (m/w/x)
Vollzeitmit HomeofficeSenior
München
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Bioanalytical activities for cancer immunotherapies, supporting clinical and non-clinical programs. 2-5 years industry experience in bioanalysis required. Partial remote work, flexible arrangements.
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Anforderungen
- Ph.D., M.Sc., or equivalent degree in relevant discipline
- 2-5 years industry experience in bioanalysis
- Experience supporting bioanalytical programs
- Experience working with external laboratories
- Experience working with external service providers
- Experience with PK assay development, validation, and analysis
- Experience with ADA assay development, validation, and analysis
- Experience with NAb assay development, validation, and analysis
- Experience with PD assay development, validation, and analysis
- Experience with non-clinical study analysis
- Experience with clinical study analysis
- Knowledge of FDA bioanalytical guidelines
- Knowledge of EMA bioanalytical guidelines
- Knowledge of ICH bioanalytical guidelines
- Knowledge of FDA immunogenicity guidelines
- Knowledge of EMA immunogenicity guidelines
- Knowledge of ICH immunogenicity guidelines
- Experience managing external laboratories
- Experience managing outsourced studies
- Knowledge of biologics
- Knowledge of immunology
- Knowledge of oncology
- Knowledge of immuno-oncology
Aufgaben
- Contribute to planning, execution, and oversight of bioanalytical activities
- Collaborate with Translational Research and Clinical Biomarkers
- Collaborate with Clinical Pharmacology
- Collaborate with Non-Clinical Safety
- Collaborate with Clinical Operations
- Collaborate with Clinical Development
- Collaborate with Regulatory Affairs
- Collaborate with external laboratories
- Provide scientific and operational oversight of PK, immunogenicity, and PD assays
- Contribute to development and execution of bioanalytical strategies
- Lead bioanalytical activities independently
- Address scientific and operational challenges proactively
- Support selection, development, qualification/validation, and implementation of PK, immunogenicity, and PD assays
- Provide scientific input to clinical and non-clinical development documentation
- Ensure bioanalytical activities align with program objectives and best practices
- Ensure bioanalytical activities align with regulatory expectations
- Support bioanalytical assay strategy discussions
- Ensure bioanalytical activities comply with GxP requirements
- Serve as primary scientific contact for external bioanalytical laboratories
- Support external vendor selection and qualification
- Monitor laboratory performance, data quality, and timelines
- Support issue resolution with external vendors
- Manage outsourced assay development and validation
- Manage outsourced clinical and non-clinical sample analysis
- Review and approve method validation reports
- Review and approve clinical and non-clinical sample analysis plans
- Review and approve data transfer specifications
- Evaluate bioanalytical results
- Provide scientific recommendations for program decision-making
- Support integrated interpretation of PK, ADA, NAb, and PD data
- Contribute to internal decision-making
- Contribute to cross-functional discussions
- Contribute to study reports
- Contribute to regulatory documentation
- Contribute to scientific publications
- Act as scientific interface between internal stakeholders and external providers
- Ensure alignment on assay strategy with external providers
- Ensure alignment on study execution with external providers
- Ensure alignment on data interpretation with external providers
- Work closely with Translational Research and Clinical Biomarkers
- Work closely with Clinical Pharmacology
- Work closely with Non-Clinical Safety
- Work closely with Clinical Operations
- Work closely with Clinical Development
- Work closely with Regulatory Affairs
- Work closely with external subject matter experts and consultants
- Present bioanalytical strategies to project teams
- Present bioanalytical results to project teams
- Present bioanalytical recommendations to project teams
- Present bioanalytical strategies to management
Berufserfahrung
2 - 5 Jahre
Ausbildung
Doktor / Ph.D.
Sprachen
Englisch – verhandlungssicher
Benefits
Attraktive Vergütung
- Competitive compensation
Flexibles Arbeiten
- Flexible working arrangements
- Partial remote work
Sicherer Arbeitsplatz
- Permanent employment contract
Sonstige Vorteile
- Attractive employee benefits
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens CatalYm erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei CatalYmÜber das Unternehmen
CA
PharmaceuticalsMünchen
CatalYm is a biotech company developing innovative immunotherapies to transform cancer patients’ lives.
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