As Assistant Project Lead you will support one or more Project Leads in Clinical Immunology with activities relating to coordination of clinical study sample analysis at Janssen Vaccines & Prevention in Leiden.
- 15 februari 2021
- vacaturenummer: 446316
Salary between 2700-4000
Free online training through GoodHabitz
A workday between 36-40 hours a week
You have experience with working in the pharmaceutical industry, particularly in clinical development of vaccines or large molecules will be a great advantage. You also meet the following qualifications:
- MSc in biological/medical sciences or equivalent, ideally with a strong immunology component. (Or a bachelors degree with relevant experience)
- Experience in working under quality standards such as GCLP, GCP or GMP is beneficial
- Excellent communication skills, fluent in English.
The Assistant Project Lead supports one or more Project Leads in Clinical Immunology with activities relating to coordination of clinical study sample analysis. These activities include preparation and update of documentation required to plan and complete clinical studies, writing of memos and meeting minutes, and drafting update slides under supervision of a PL. The Assistant Project Lead may also connect with internal partners on operational/logistic processes. As documentation and discussions will often be of a technical nature, a background in a relevant scientific subject is necessary.
The required activities must be executed, documented and reported according to Good Clinical Laboratory Practice (GCLP) quality requirements.
The Assistant Project Lead will report to a Senior PL, and work as part of a team of PLs covering the Emergency Programs.
The Clinical Immunology department is responsible for the immunological evaluation of vaccine candidates in clinical trials. In close collaboration with the Biomarkers 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. Within CI, Project Leads (PLs) are 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 immuno assay data.
After receiving your application, you will hear from us within 24 hours. If we find you suitable based on your CV and motivation, we will call you for a selection interview by telephone and ask you for two references. If the outcome of the selection interview is positive, we will introduce you to Janssen Vaccines & Prevention.