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 (Barcelona)
🏢 Almirall
📍 Barcelona