One of our leading Biotech clients has an opening for an Assistant Project Lead in Leiden. We are looking for someone who has experience with immunology/clinical development and GCLP/GLP/GCP/GMP in the pharmaceutical industry.
The Clinical Immunology (CI) 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 this company 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 immunoassay data.
- Supporting one or more Project Leads (PLs) 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.
- Connecting 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 an accelerated and breakthrough designated program.
- MSc in biological/medical sciences or equivalent, ideally with a strong immunology component.
- Experience working in the pharmaceutical industry, particularly in clinical development of vaccines or large molecules would be a great advantage.
- Experience in working under quality standards such as GCLP, GCP or GMP is beneficial.
- Excellent communication skills, fluent in English.
The right candidate is:
- Organized, with an eye for details and a passion for delivering high-quality work.
- Flexible and able to remain calm and positive under pressure.
- A team player, able to work simultaneously on multiples projects and work with other team members to prioritize activities.
- Independent thinker, and not afraid to challenge the status quo to find efficiencies.
PROJECT START DATE
12 months + possible extension / perm
If you are interested in the above description, please apply with your CV and a letter of motivation by clicking on the ‘apply’ button below.
PS: Did you also know that we offer a generous referral scheme, because great people know other great people, right?
For further information, please contact Ralph Looijen at +31 (0)20 20 44 502 or by email at firstname.lastname@example.org