Experteer Overview In this role you will lead ADME/DMPK investigations within Almirall's Ru**amp;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 u*
* Simulation concepts
• Strong knowledge of regulatory requirements for ADME/DMPK and regulatory de-risking of submissions Requisitos principales •