The Project Scientist is the main point of contact between Clinical Immunology and all internal & external parties involved in the execution of a clinical trial. the Project Scientist uses his/her scientific expertise to understand the needs of the stakeholders in terms of immunological readout
Janssen Vaccines & Prevention is a leading biotechnology company developing vaccines against infectious diseases. LabResource has been elected as their top supplier for the second year in a row and has been contracted to recruit for this position.
The Project Scientist is the main point of contact between Clinical Immunology and all internal & external parties involved in the execution of a clinical trial. the Project Scientist uses 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.
- 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.
- Translating the needs of the stakeholders into departmental goals and requests resources to address them.
- Providing input in all documentation required to plan and complete clinical studies.
- Working with outsourcing labs to ensure the availability and suitability of assays for clinical studies.
- Input in the immunostrategies and documentation of clinical studies.
- Estimating & and communicating timelines for the delivery of immunological data.
- updating 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.
- 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.
- Full time preferred, 32 hours discussable
Salary and Benefits
Contract: 1 year, realistic long term perspectives
Salary: ranging from 3800 - 4300 gross monthly
Interesse, klik op de solliciteerknop om direct te solliciteren. Ook kun je telefonisch contact opnemen met LabResource via T.: 020 - 406 9750 of een CV per e-mail toesturen naar email@example.com.
Solliciteer op deze functie