23 oct
|
Almirall
|
San Feliú de Llobregat
23 oct
Almirall
San Feliú de Llobregat
Experteer Overview
In this role you will lead ADME/DMPK investigations to support non-clinical and clinical development of NBEs, including innovative modalities like mRNA LNPs. You will work within cross-functional project teams to inform decisions, design translational strategies, and ensure regulatory-ready PK/PD deliverables. You’ll communicate findings to stakeholders and contribute to regulatory submissions. The work combines scientific leadership with collaborative execution to advance dermatology-focused therapies.
Compensaciones / Ventajas
• Represent the ADME/DMPK function in cross-functional projects and external collaborations to drive informed decisions
• Oversee studies to enhance ADME/DMPK knowledge across non-clinical and clinical development
• Manage bioanalytical needs (PK, ADA, Nab, biomarkers) for non-GLP/GLP ADME/DMPK studies
• Contribute to pre-clinical/clinical translational strategy design and MIDD approaches
• Ensure PK, PK/PD, and dose prediction deliverables meet best-practice standards and regulatory needs
• Provide high-quality data and presentations for internal and partner updates
• Author regulatory-supportive reports and documents (INDs, CTAs, MAA, BLA as needed)
• Evaluate external assets for ADME/DMPK and communicate findings to stakeholders
• Maintain up-to-date knowledge of scientific literature and regulatory guidance
Responsabilidades
• MSc/PhD in Pharmacy, Chemistry, Biochemistry, Biology, biomedicine or related Life Sciences
• ≥5 years of experience in ADME/DMPK/Bioanalysis of Biologic Drugs
• Experience with mRNA LNPs and NCE projects is valued
• Strong knowledge of regulatory bioanalytical aspects for biotherapeutics including clinical immunogenicity
• Understanding of translational medicine to connect preclinical/clinical ADME/DMPK with Modelling u0026 Simulation concepts
• Comprehensive knowledge of regulatory requirements for ADME/DMPK and de-risking submissions
Requisitos principales
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📌 SENIOR SCIENTIST (San Feliú de Llobregat)
🏢 Almirall
📍 San Feliú de Llobregat