Be a member of R&D teams to provide an expert DMPK & Bioanalysis support to Large Molecule therapy projects.
Implementation and validation of adequate bioanalytical strategies, with focus on PK assays, PD assays and immunogenicity assays, across the project lifecycle in a multidisciplinary environment.
Coordinate sample analysis including non-regulated or regulated pre-clinical and clinical studies.
Supervision and monitoring of external bioanalytical and ADME/DMPK studies.
Tasks and Responsibilities
Participation, performance, direction or outsourcing of studies to improve the knowledge of ADME/DMPK of drugs under development.
Implement, develop, optimize, validate, or outsource Ligand Binding Assays for PK, PD or Immunogenicity testing.
Take responsibility of all bioanalytical needs in house or from external vendors to support non-clinical and clinical studies.
Responsible for the analysis, interpretation and reporting of data generated both internally and from external vendors.
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.
Ensure the correct fulfillment of GLPs for regulated bioanalytical activities and the alignment with international regulations when necessary.
Preparation and approval of SOPs (Standard Operating Procedures) in the field of Bioanalysis and Pharmacokinetics/Metabolism.
Collaborate with and support Non-Clinical, Clinical, Regulatory, Project Management or other R&D disciplines.
Author high quality reports, including support to regulatory documents including INDs, CTAs and NDA filings when needed.
Education
PhD in Pharmacy, Chemistry, Biochemistry or Biology
Specific Knowledge
Good knowledge of regulatory bioanalysis and excellent expertise/hands-on in the development/validation of Ligand Binding Assays for PK, PD or Immunogenicity testing.
Experience in Biomarker assays using LBA or other bioanalytical platforms will be valued.
Specific bioanalytical knowledge applied to both small and large molecules (LC-MS/MS) is a plus.
Experience in the use of pharmacokinetic analysis software, such us Phoenix, and good understanding of the PK and PK/PD principles to interpret results.
Experience
5+ years of experience in the field of ADME/DMPK/Bioanalysis of Large Molecule Drugs.
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.
Courage: we challenge the status quo, we take full ownership and we learn from our success & failures
Innovation: we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets.
Simplicity: we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.
