Job Description
The successful candidate will be a member of R&D project teams, providing expert ADME&DMPK support across the project lifecycle in a multidisciplinary environment. Key responsibilities include ensuring ADME profiling, PK/PD, M&S, and human dose predictions are undertaken to best practice standard for study design and decision making.
Key Tasks
* Select, set up, supervise or incorporate the appropriate in-vitro/in-vivo models to address ADME/DMPK aspects at all stages from feasibility to candidate nomination and early clinical development.
* Be responsible for outsourcing and coordination of experimental ADME/DMPK in vitro or in vivo studies when needed.
* Provide bioanalytical support for ADME/DMPK studies, either in-house or through external vendors.
* Support PK/PD analysis using modeling & simulation tools for human PK predictions enabling human dose projection or safety evaluation.
* Deliver high-quality reports and presentations to ensure regular progress updates of ongoing projects.
* Collaborate with other disciplines across the R&D organization.
* Maintain an up-to-date knowledge of the relevant scientific literature and regulatory guidance.
Requirements
* PhD in Pharmacy, Chemistry, Biochemistry, or Biology.
* In-depth understanding of ADME processes applied to NCEs and screening strategies from feasibility to candidate nomination.
* Good knowledge of bioanalysis, including expertise in LC-MS/MS platforms.
* Experience in pharmacokinetic analysis software, such as Phoenix, and good understanding of PK and PK/PD principles.
* Knowledge of tools and strategies for human PK predictions based on preclinical data and mechanistic PK/PD data interpretation.
Desired Qualifications
* 5+ years of experience in ADME/DMPK/Bioanalysis of Small Molecule Drugs.
* Experience in 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.