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ADME & DMPK Senior Scientist
hace 2 meses
We are seeking a highly skilled ADME/DMPK Senior Scientist to join our team at Almirall. As a key member of our Research and Development (R&D) project teams, you will provide expert support across the project lifecycle, focusing on ADME profiling, PK/PD, MS, and human dose predictions.
Key Responsibilities- Selection, setup, supervision, or incorporation of in-vitro/in-vivo models to address ADME/DMPK aspects at all stages from feasibility to candidate nomination and early clinical development.
- Responsible for outsourcing and coordination of experimental ADME/DMPK in vitro or in vivo studies when needed.
- Responsible for all bioanalytical needs, in-house or from external vendors, to support ADME/DMPK studies.
- PK/PD support and use of modeling simulation tools for human PK predictions enabling human dose projection or safety evaluation.
- Provide quality data, written reports, and presentations, internally or to possible partners, to ensure regular progress updates of ongoing projects.
- Author high-quality reports, including support to regulatory documents, when needed.
- Collaborate with and support other disciplines across the R&D organization.
- Maintain an up-to-date knowledge of the relevant scientific literature as well as regulatory guidance and best practice.
- PhD in Pharmacy, Chemistry, Biochemistry, or Biology.
- In-depth understanding of the ADME processes applied to NCEs and in the screening strategies from feasibility to candidate nomination.
- Knowledge of the ADME/DMPK processes for NBEs is a plus.
- Good knowledge of bioanalysis and expertise in the use of the LC-MS/MS platforms.
- Specific bioanalytical knowledge applied to both small and large molecules (e.g., using LBA) is a plus.
- Experience in the use of pharmacokinetic analysis software, such as Phoenix, and good understanding of the PK and PK/PD principles to interpret results.
- Good knowledge of the tools and strategies for human PK predictions based on preclinical data and in the mechanistic PK/PD data interpretation.
- Additional knowledge in the use of tools for modeling and simulation of dynamic systems (such as SimBiology) is a plus.
- Experience of 5+ years in the field of ADME/DMPK/Bioanalysis of Small Molecule Drugs.
- Experience or specific knowledge applied to the ADME/DMPK of therapeutic proteins is a plus.
- Teamwork and personal leadership.
- Ability to work in a matrix environment, multi-task, meet deadlines, and deal with evolving priorities.
- Excellent communication and written skills in English.
- Care: we listen, empathize, value diverse perspectives, backgrounds, and help each other succeed.
- Courage: we challenge the status quo, take full ownership, and learn from our success and failures.
- Innovation: we put the patient and customer at the center, create novel solutions, and empower entrepreneurial mindsets.
- Simplicity: we act decisively, avoid over-analysis, understand why before we act, and are agile and keep things simple.
