ADME & DMPK SENIOR SCIENTIST

An ADME&DMPK Senior Scientist plays a key role in Almirall's R&D organization by leading scientific investigations and contributing to the development of innovative therapeutic solutions. In this position a senior scientist will be a member of R&D project teams to provide ADME & DMPK guidance across the non-clinical and clinical development of NBEs, including new drug modalities such as mRNA LNPs, in a multidisciplinary environment.

Responsibilities

Represent the function in cross-functional teams or in collaboration with external partners, to deliver data and drive informed decision-making aligned with project goals; Ensure the proper flow of information between the project, the function, and key stakeholders; Participate in, direct, or outsource studies to improve knowledge of ADME/DMPK across non-clinical and clinical development; Be responsible for bioanalytical needs (e.g. PK, ADA, Nab or biomarker assays) to support non-GLP or GLP ADME/DMPK studies, ensuring adherence to global regulatory standards (e.g., FDA, EMA); Contribute to the design of pre-clinical and clinical translational strategies and MIDD approaches; Ensure PK, PK/PD, dose predictions or other related non-clinical or clinical PK deliverables are undertaken to best practice standards for study design and regulatory submissions; Provide high-quality data and presentations, internally and to potential partners, to ensure regular progress updates; Author high-quality reports, including support to regulatory documents such as INDs, CTAs, MAA or BLA filings when needed; Evaluate external assets (DDs) for nonclinical and clinical ADME/DMPK and communicate findings and recommendations to stakeholders; Maintain up-to-date knowledge of relevant scientific literature, regulatory guidance and best practice

Requirements

MSc/PhD in Pharmacy, Chemistry, Biochemistry, Biology, biomedicine or related Life Sciences; 5+ years of experience in the field of ADME/DMPK/Bioanalysis of Biologic Drugs; Good knowledge of the regulatory bioanalytical aspects for biotherapeutics, including clinical immunogenicity activities during development; Good understanding of translational medicine aspects to connect Preclinical/Clinical ADME&DMPK, including adequate knowledge of Modelling&Simulation concepts; Comprehensive knowledge of regulatory requirements and guidelines related to ADME/DMPK, enabling effective de-risking of regulatory submissions

Nice to have

Experience with mRNA LNPs and NCE projects; Strong analytical and critical thinking skills; Ability to work independently and in cross-functional teams; Excellent communication and scientific writing abilities; Fluent in both oral and written English; Strategic thinker and ability to build and maintain professional networks; Collaborative team player who values diverse perspectives; Demonstrates ownership, accountability, and the courage to challenge the status quo; Results-oriented and agile, able to simplify complexity and make effective decisions; Excellent inter-cultural understanding