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 m RNA 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 guidanceResponsabilidades -
MSc/Ph D in specified Life Sciences fields -
5+ years in ADME/DMPK/Bioanalysis of Biologic Drugs -
Experience with m RNA 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 submissionsRequisitos principales -