21 ago
|
Alexion Pharmaceuticals
|
Barcelona
21 ago
Alexion Pharmaceuticals
Barcelona
Experteer Overview
In this Barcelona-based role, you will lead non-clinical activities in early drug development to support preclinical programs. You will work with cross-functional teams and CROs to ensure high-quality, timely studies and data interpretation. Your expertise will drive regulatory-compliant study execution and clear communication of results to project teams. This position offers a hands-on opportunity to shape preclinical strategies within a global Rare Disease program. You will combine scientific leadership with collaboration in a fast-paced, onsite environment three days a week.
Compensaciones / Ventajas
• Oversee design, execution, management and reporting of preclinical studies (PK, toxicology, reproduction toxicology, genotoxicity, carcinogenicity, safety pharmacology)
• Select and manage CRO partnerships considering expertise, quality, cost and timelines
• Serve as primary CRO contact for contracts, invoicing, study setup, monitoring, site visits and reporting
• Identify and resolve scientific, technical, logistical or quality issues in studies
• Ensure studies comply with GLP,
regulatory and quality requirements
• Review and interpret data; coordinate high-quality report review and finalization
• Summarize and communicate results to project teams and management
• Coordinate activities with other departments (finances, CMC, bioanalysis, regulatory)
• Monitor developments in the field and ensure alignment with regulatory changes
Responsabilidades
• PharmD, VetD, or Master’s degree in biology, animal sciences, toxicology or related fields
• 3–5 years of experience as a toxicology study director/monitor in pharma, biotech or CRO settings
• Expertise in management of nonclinical studies and GLP data interpretation
• Experience delivering studies within budgets and timelines
• Strong interpersonal and communication skills with internal and external stakeholders
• Good organizational, planning and project management abilities
• Proficiency in English (written and spoken)
Requisitos principales
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📌 Non-Clinical Toxicology Manager (Barcelona)
🏢 Alexion Pharmaceuticals
📍 Barcelona