The companyOur client is a professional Pharmaceutical organisation, based in Zuid-Holland Netherlands. Our client is a professional Pharmaceutical and Biotechnology organisation, based in Zuid-Holland Netherlands. Janssen Vaccines & Prevention, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to bringing meaningful innovation to global health. The teams focus on the discovery, development, manufacture and marketing of vaccines and antibodies to protect people worldwide from infectious diseases.
Role descriptionThe Clinical Immunology department is responsible for the immunological evaluation of vaccine candidates in clinical trials. In close collaboration with the Biomarker group and Clinical Development group, the Clinical Immunology department executes the immuno strategies and ensures the development, and validation of the required immunological assays as well as clinical sample analysis and data reporting. Typical assays to determine the immunogenicity of vaccines are the antibody ELISA, T cell ELISpot, Intracellular Cytokine Staining, and virus neutralization assays. The Clinical Immunology department offers Janssen Vaccines with services in scientific and operational excellence, with high standards of quality and compliance.
The Project Scientist is the main point of contact between Clinical Immunology (CI) and all parties involved in the execution of a clinical trial. These parties can be internal -Operations, Analytical Project Managers or Subject Matter Experts (SMEs)-; or external -Biomarkers, Global Clinical Development Organization, Data Management etc.
ResponsibilitiesWithin Clinical Immunology, the project scientist is responsible for the day-to-day coordination of one or several clinical studies, starting from the planning of a clinical protocol to the close-out and reporting immunological assay data to the statistical department for analysis. He/she translates the needs of the stakeholders into departmental goals and requests resources to address them. He/she provides input in all documentation required to plan and complete clinical studies. He/she also works with the SMEs and outsourcing labs to ensure the availability and suitability of assays for clinical studies; and with the Analytical Project Managers to oversee the shipment of samples, sample analysis and the data transfer to Data Management for analysis and reporting.
Outside Clinical Immunology, the project scientist is responsible for the Clinical Immunology input in the immunostrategies and documentation of clinical studies. He also estimates and communicates timelines for the delivery of immunological data. He updates the team regarding the quality status of the required assays, the actions needed to ensure assay suitability, the readiness of the sample processing labs, the shipment and analysis of samples and the availability of results.
Besides his project responsibilities, the Project Scientist must also use his scientific expertise to understand the needs of the stakeholders in terms of immunological readouts, the principles of the assays in his studies, and the rationale behind their development, qualification or validation.
Requirements- PhD in biological/medical sciences or equivalent, with strong immunology or virology background;
- At least 1 year of experience in business or research;
- Scientific and project management skills, team work, problem solving abilities.
- Experience in multi-color flow cytometry, virus neutralization assays, ELISA, ELISPOT, assay development and validation requirements, and knowledge of FDA/EMA/ICH regulatory guidelines is a plus.
- Experienced in working under quality standards such as GCLP, GCP or GMP is a plus.
- Fluent in English
Other informationDo you have at least one year of experience within a pharmaceutical company leading clinicial trials?
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Hélène de Vries.