ADME & DMPK SENIOR SCIENTIST (San Feliú de Llobregat)

ADME & DMPK SENIOR SCIENTIST (San Feliú de Llobregat)

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 within Almirall’s Ru0026amp;D to support non-clinical and clinical development of NBEs, including novel modalities like mRNA LNPs. You will work across cross-functional teams to drive data-driven decisions, design translational strategies, and ensure regulatory-compliant bioanalysis. This is a hands-on position that shapes translational science and contributes to regulatory submissions. You will partner with external collaborators and internal stakeholders to advance patient-focused therapies. Compensaciones / Incentivos
• Represent the function in cross-functional teams to deliver data and drive decisions
• Coordinate studies to improve ADME/DMPK knowledge across non-clinical and clinical development
• Lead bioanalytical needs (PK, ADA, Nab, biomarkers) for non-GLP/GLP studies and ensure regulatory adherence
• Contribute to pre-clinical and clinical translational strategies and MIDD approaches
• Ensure PK, PK/PD,



and dose prediction deliverables meet best-practice standards for studies and submissions
• Provide high-quality data and presentations for progress updates
• Author reports and support regulatory documents (INDs, CTAs, MAAs, BLAs) as needed
• Evaluate external assets (DDs) for nonclinical and clinical ADME/DMPK and communicate findings to stakeholders
• Maintain up-to-date knowledge of literature and regulatory guidance Responsabilidades
• MSc/PhD in specified Life Sciences fields
• 5+ years in ADME/DMPK/Bioanalysis of Biologic Drugs
• Experience with mRNA LNPs and NCE projects valued
• Knowledge of regulatory bioanalytical aspects for biotherapeutics including immunogenicity
• Understanding of translational medicine and Modeling u0026 Simulation concepts
• Strong knowledge of regulatory requirements for ADME/DMPK and regulatory de-risking of submissions Requisitos principales •

📌 ADME & DMPK SENIOR SCIENTIST (San Feliú de Llobregat)
🏢 Almirall
📍 San Feliú de Llobregat

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