Mission: Be a member of R&D project teams to provide expert ADME & DMPK support across a project lifecycle in a multidisciplinary environment with special focus between the early stages of drug discovery through candidate nomination and early clinical development.
Ensure that ADME profiling, PK/PD, M&S, human dose predictions or other related deliverables are undertaken to best practice standards for study design and decision making to move candidates to preclinical/clinical development.
Tasks and Responsibilities:
Selection, set-up, supervision or incorporation of the appropriate 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.
Education:
PhD in Pharmacy, Chemistry, Biochemistry or Biology.
Specific Knowledge:
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:
5+ years of experience 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.
Competencies:
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.
Values:
Care: we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.
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