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We are seeking a highly skilled Senior Scientist to join our Research and Development team at Almirall. As an ADME & DMPK expert, you will play a critical role in providing expert support across the project lifecycle, from early stages of drug discovery to candidate nomination and early clinical development.
Key Responsibilities- Design and execute ADME profiling, PK/PD, MS, and human dose predictions to best practice standards for study design and decision making.
- Develop and implement in-vitro/in-vivo models to address ADME/DMPK aspects at all stages from feasibility to candidate nomination and early clinical development.
- Coordinate and oversee experimental ADME/DMPK in vitro or in vivo studies, as needed.
- Provide bioanalytical support, in-house or from external vendors, to support ADME/DMPK studies.
- Support PK/PD modeling and simulation tools for human PK predictions, enabling human dose projection or safety evaluation.
- Author high-quality reports, including support to regulatory documents, as needed.
- Collaborate with and support other disciplines across the RD organization.
- PhD in Pharmacy, Chemistry, Biochemistry, or Biology.
- In-depth understanding of ADME processes applied to NCEs and screening strategies from feasibility to candidate nomination.
- Knowledge of ADME/DMPK processes for NBEs is a plus.
- Good knowledge of bioanalysis and expertise in the use of LC-MS/MS platforms.
- Experience in pharmacokinetic analysis software, such as Phoenix, and good understanding of PK and PK/PD principles.
- Good knowledge of tools and strategies for human PK predictions based on preclinical data and mechanistic PK/PD data interpretation.
- 5+ years of experience in ADME/DMPK/Bioanalysis of Small Molecule Drugs.
- Experience or specific knowledge applied to 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.