ADME & DMPK Senior Scientist

ADME & DMPK Senior Scientist Almirall Sant Feliu de Llobregat, France MISSION 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. CORE 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 that the proper flow of information between the project, the function, and key stakeholders is in place; Participation, performance, direction or outsourcing of studies to improve the knowledge of ADME/DMPK across non-clinical & clinical development; Responsible for the bioanalytical needs (e.g. PK, ADA, Nab or biomarker assays) to support non-GLP or GLP ADME/DMPK studies across drug development, as well as ensure adherence to global regulatory standards (e.g., FDA, EMA); Contribute to the design of pre-clinical and clinical translational strategies and MIDD approaches in collaboration with non-clinical and clinical departments; Ensure that PK, PK/PD, dose predictions or other related non-clinical or clinical PK deliverables are undertaken to best practice standard for study design and regulatory submissions; Provide high-quality data and presentations, both internally and to potential partners, to ensure regular progress updates on ongoing projects; Author high-quality reports, including support to regulatory documents, such as INDs, CTAs, MAA of BLA filings when needed; Evaluate external assets (DDs) for nonclinical and clinical ADME/DMPK, and clearly communicate findings and recommendations to stakeholders; Maintain an up-to-date knowledge of the relevant scientific literature as well as regulatory guidance and best practice. REQUIRED EDUCATION AND EXPERIENCE 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. Experience with mRNA LNPs and NCE projects will be valued; 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, which includes adequate knowledge of Modelling&Simulation concepts; Comprehensive knowledge of regulatory requirements and guidelines related to ADME/DMPK, enabling effective de-risking of regulatory submissions. PREFERRED SKILLS AND COMPETENCIES 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 to support collaborative efforts; Collaborative team player who values diverse perspectives and supports collective success; 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. Apply Now