Clinical Scientist

Clinical Scientist

argenx

Gent, Belgium

For the expansion of our Clinical team, argenx is looking for a Clinical Scientist who is responsible for the implementation of a clinical program to meet corporate and clinical research goals.

He/she will be the clinical/scientific contact for the clinical trial team of a rheumatology indication (a cross-functional team that includes Clinical Operations, Medics, Data Management, Statistics, Drug Safety, Regulatory Affairs, Medical Affairs, Clinical Quality Assurance, Sample Management, Market Research and Project Management).

He/she operationalizes scientific aspects of the clinical trial protocol and combines knowledge acquired from non-clinical research (in cell cultures and/or animal models) with clinical and biomarker research on human samples, to improve the treatment of patients and boost our understanding of disease.

This role is based in Zwijnaarde (Ghent) and expects regular presence in the office.

Key Accountabilities/Responsibilities:

The Clinical Scientist will have the following key responsibilities:

• Review and provide clinical and scientific input to the study protocol, Informed Consent Form (ICF), Statistic Analysis Plan, Monitoring Plans, Risk Management Plan, Clinical Study Reports, Case Report Forms (CRFs), edit specifications/checks, CRF completion guidelines, Study Charters and relevant regulatory documents, as required;
• Assist in the identification and review of protocol deviations during study conduct;
• Monitor clinical study data to ensure data quality and consistency;
• Perform ongoing resolution of issues arising from patient clinical management e.g. patient eligibility and study conduct;
• Supports the development of the scientific section of study-specific guidelines;
• Ensure that clinical study milestones are aligned from a clinical/scientific perspective and consistent with the clinical program;
• Review and supports external content development such as scientific posters, manuscripts, …;
• Perform analysis of biomarker, non-clinical and clinical study data in order to develop a deep scientific understanding of our drug candidates;
• Participate in the outreach for medical and regulatory advice and address any clinical / scientific issues arising from regulatory authorities and ethics committees;
• Support the study team with scientific expertise at study site initiation and subsequent motivational visits, as required.
• Conduct trial specific biomarker and translational research

Desired Skills and Experience:

• PhD in Immunology or Molecular Biology with at least 3 years of relevant research/industry experience, or Master degree with extensive industry experience in the fields of rheumatology and/or immunology;
• Knowledge of clinical research, including basic statistics, pharmacodynamics and pharmacokinetics;
• Knowledge of GCP and ICH Guidelines is a plus; Experience in non-clinical and clinical research is a plus;
• Ability to analyze and assimilate technical and scientific data and to apply knowledge;
• Good communication skills and good written and oral English language skills;
• Excellent interpersonal skills;
• Detail-oriented and well-organized.

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