Project Scientist Clinical Immunology (Yacht Life Sciences)
YACHT
Leiden
13 dagen geleden

Over de functie

Yacht Life Sciences has a vacancy for a Project Scientist Clinical Immunology.

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 of immunological assay data to the statistical department for analysis. The Project Scientist translates the needs of the stakeholders into departmental goals and requests resources to address them.

  • The Project Scientist provides input in all documentation required to plan and complete clinical studies. The Project Scientist 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.

    The Project Scientist also estimates and communicates timelines for the delivery of immunological data. The Project Scientist 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.

    Skills :

  • 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
  • Competences : The right candidate is :

    The right candidate is :

  • Quality minded and flexible
  • Able to remain calm and positive under pressure
  • A team player with good interpersonal skills, able to motivate and empower others
  • Good planning and coordinating skills
  • Excellent communication skills
  • Arbeidsvoorwaarden

    We will offer a competitive benefits package in line with the seniority of the position. You will become a member of a strong professional network who shares your education, ambitions and competencies.

    This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry.

    You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-

    to-date : boosting your career through personal and scientific growth.

    Bedrijfsinformatie

    A global biotech company that focuses on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases.

    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 the company services in scientific and operational excellence, with high standards of quality and compliance.

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