OverviewIn this role you will lead ADME/DMPK investigations within Almirall's R&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.
ResponsabilidadesRepresent 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
Requisitos principalesMSc/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 & Simulation concepts
Strong knowledge of regulatory requirements for ADME/DMPK and regulatory de-risking of submissions
Analytical and critical thinking
Ability to work independently and in cross-functional teams
Excellent communication and scientific writing
ADME/DMPK and bioanalysis of biologics
PK, PK/PD, dose prediction
Bioanalytical assays (PK, ADA, Nab, biomarkers)

📌 Adme & Dmpk Senior Scientist - Almirall (España)
🏢 Almirall
📍 España