Required Translational and Bioanalytical Research Associate
Job Description
The Translational and bioanalytical research associate will oversee the Companys translational and bioanalytical activities that are essential for drug development activities, preclinical and clinical. This typically includes bioanalytical methods development and use for pharmacokinetic and immunogenicity evaluation, as well as methods needed for pharmacodynamic exploration, such as cytokines, receptor occupancy, immunophenotyping, and a support for drug manufacturing development activities (CMC). The candidate will ensure the methods are developed, validated, and used with the highest degree of quality and compliance with international regulations.
The candidate will work with cross functional teams across the organization (preclinical biomarker/translational research, clinical development, clinical operations, CMC, regulatory, clinical data management) to ensure the successful PK and PD sample analysis for investigational drugs in our pipeline.
Be responsible for the bioanalytical methods required for our various therapeutic programs at preclinical and clinical development stage. This includes assay set-up, optimization, validation, execution, tracking of program and study timelines, review of bioanalytical protocols and reports
Propose format and strategy for pharmacokinetic and pharmacodynamic assays, immunogenicity assays such as ADA and NAb assay, flow cytometry immunophenotyping panels, Receptor occupancy assays, etc.)
Support the selection and the oversight of external advisors/Contract Research Organizations, including participating to quality assurance audits
Monitor internal and external work on bioanalytical methods
Collaborate with scientific colleagues in the R&D units from discovery to clinical teams
Maintain an up-to-date understanding of the state-of-the-Art literature, requirements, and regulatory guidelines for bioanalytical methods used in drug development
Present written and oral reports to preclinical units and management
Contribute to Project Management activities such as definition of activities, timelines, and costs/budgets
Contribute to the data analysis and summaries of results derived from pre-clinical and clinical sample analysis
Contribute to preclinical and clinical documentation definition and writing for the sections related to bioanalytical methods.
Requirements: Bachelors degree with 2 4 years of experience or Masters degree with 0 2 years of experience in relevant disciplines
Ability to select and work with international Contract Research Organizations of various size
Knowledge of Regulatory requirement for the preclinical and clinical development of drugs
Knowledge of Good Quality Practices, mainly GLP and GCP
Prior experience in oncology or immune-oncology early clinical development and/or bioassays/ biomarker or PK/PD would be a plus
Knowledge and experience with ligand biding assays flow cytometry-based technologies, functional assays, immunogenicity exploration (ADA, Nab Assays)
Knowledge of mass spectrometry technology applications to bioanalysis of proteins would be a plus
Ability to act proactively and effectively applying creative problem-solving skills
Good planning, organizational and communication skills (including, written and oral presentation skills)
Ability to generate and maintain highly ordered and efficient processes, including critical Bioassays reagents follow up, monitoring, resupply, and QC
Team player Ability to work within multidisciplinary matrix team, internal and external, including advisors/consultants.
This position is open to all candidates.