In this senior scientist role, you lead ADME/DMPK investigations within Almirall’s R&D; to support non-clinical and clinical development of NBEs, including mRNA LNPs. You collaborate with cross-functional teams and external partners to deliver data-driven decisions and ensure regulatory-aligned bioanalytical strategies. You will shape translational plans, contribute to PK/PD deliverables, and communicate progress to stakeholders and regulatory bodies.
Responsabilidades
- Lead cross-functional or partner-enabled projects to deliver ADME/DMPK data aligning with project goals
- Coordinate non-clinical and clinical ADME/DMPK studies and outsourcing to deepen knowledge
- Oversee bioanalytical needs (PK, ADA, Nab, biomarkers) for ADME/DMPK studies across development with regulatory compliance
- Contribute to pre-clinical/clinical translational strategy and MIDD approaches
- Ensure PK/PK–PD deliverables and dose prediction work meet best-practice standards for studies and submissions
- Deliver high-quality data and presentations to internal teams and external partners
- Author reports and support regulatory documents (INDs, CTAs, MAAs, BLA filings as needed)
- Evaluate external assets for ADME/DMPK and communicate findings to stakeholders
- Maintain up-to-date knowledge of literature, regulatory guidance and best practices
Requisitos principales
- MSc or PhD in Life Sciences or related field
- 5+ years in ADME/DMPK/Bioanalysis of Biologic Drugs
- Experience with mRNA LNPs and NCE projects valued
- Strong knowledge of regulatory bioanalytical aspects for biotherapeutics
- Understanding of translational medicine and MIDD concepts
- Knowledge of regulatory requirements for ADME/DMPK and risk de-risking for submissions
- Strong analytical and critical thinking
- Independent working style and cross-functional collaboration
- Excellent communication and scientific writing
- ADME/DMPK
- Bioanalysis
- PK/PK–PD
📌 SENIOR SCIENTIST (Sant Feliu de Llobregat)
🏢 Almirall
📍 Sant Feliu de Llobregat
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