28 oct
|
Almirall
|
Barcelona
28 oct
Almirall
Barcelona
Experteer Overview In this role you will lead ADME/DMPK investigations to support non-clinical and clinical development of NBEs, including innovative modalities like mRNA LNPs.
You will work within cross-functional project teams to inform decisions, design translational strategies, and ensure regulatory-ready PK/PD deliverables.
You'll communicate findings to stakeholders and contribute to regulatory submissions.
The work combines scientific leadership with collaborative execution to advance dermatology-focused therapies.
Compensaciones / Incentivos • Represent the ADME/DMPK function in cross-functional projects and external collaborations to drive informed decisions • Oversee studies to enhance ADME/DMPK knowledge across non-clinical and clinical development • Manage bioanalytical needs (PK, ADA, Nab, biomarkers) for non-GLP/GLP ADME/DMPK studies • Contribute to pre-clinical/clinical translational strategy design and MIDD approaches • Ensure PK, PK/PD,
and dose prediction deliverables meet best-practice standards and regulatory needs • Provide high-quality data and presentations for internal and partner updates • Author regulatory-supportive reports and documents (INDs, CTAs, MAA, BLA as needed) • Evaluate external assets for ADME/DMPK and communicate findings to stakeholders • Maintain up-to-date knowledge of scientific literature and regulatory guidance Responsabilidades • MSc/PhD in Pharmacy, Chemistry, Biochemistry, Biology, biomedicine or related Life Sciences • ?5 years of experience in ADME/DMPK/Bioanalysis of Biologic Drugs • Experience with mRNA LNPs and NCE projects is valued • Strong knowledge of regulatory bioanalytical aspects for biotherapeutics including clinical immunogenicity • Understanding of translational medicine to connect preclinical/clinical ADME/DMPK with Modelling u**** Simulation concepts • Comprehensive knowledge of regulatory requirements for ADME/DMPK and de-risking submissions Requisitos principales •
📌 (Senior) Research Scientist (Barcelona)
🏢 Almirall
📍 Barcelona