Translational and Bioanalytical Associate Scientist

Job Description:

The Translational and Bioanalytical Associate Scientist will oversee the Company’s translational and bioanalytical activities that are essential for drug development activities, preclinical and clinical. This typically includes bioanalytical methods development and use for pharmacokinetic (PK) and immunogenicity evaluation, as well as methods needed for pharmacodynamic (PD) 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 Compugen pipeline.

Qualification:

• Be responsible for the bioanalytical methods required for Compugen’s 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 PK and PD 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 preclinical and clinical sample analysis
• Contribute to preclinical and clinical documentation definition and writing for the sections related to bioanalytical methods

Responsibilities:

• Master's degree with 2 - 4 years of experience or Ph.D. degree with 0 - 2 years of experience in relevant disciplines
• Ability to select and work with international Contract Research Organizations of various sizes
• 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 immuno-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 Bioassay’s reagents follow up, monitoring, resupply, and QC
• Team player - Ability to work within multidisciplinary matrix team, internal and external, including advisors/consultants