- Leiden, South Holland
Hours per week: 40
The 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 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 (APMs) or Subject Matter Experts (SMEs)-; or external -Biomarkers, Global Clinical Development Organization, Data Management etc.
Within CI, 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 APMs to oversee the shipment of samples, sample analysis and the data transfer to Data Management for analysis and reporting.
Outside CI, the project scientist is responsible for the CI input in the immunostrategies and documentation of clinical studies. He/she also estimates and communicates timelines for the delivery of immunological data. He/she 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/her project responsibilities, the Project Scientist must also use his/her scientific expertise to understand the needs of the stakeholders in terms of immunological readouts, the principles of the assays in his/her studies, and the rationale behind their development, qualification or validation.
* PhD in biological/medical sciences or equivalent, with strong immunology or virology background
* 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.
* Excellent communication skills, fluent in English.
* Experienced in working under quality standards such as GCLP, GCP or GMP is a plus.
Are you the new Scientist? Apply now online or to speak to Michelle Smit via 020 522 15 88 or m.smit[a]realstaffing.com