Clinical Scientist

☞ Argenx

Ver: 120

Dia de atualização: 26-11-2025

Localização: Ghent East Flanders

Categoria: Gestão executiva

Indústria:

Tipo de empregos: Full-time

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Conteúdo do emprego

For the expansion of our Clinical team, argenx is looking for a Clinical Scientist who directs the planning and implementation of clinical programs to meet corporate and clinical research goals.
He/she will be the primary clinical/scientific contact for one or multiple clinical studies and provides clinical research expertise within the cross-functional team (that includes Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory Affairs, Clinical Quality Assurance, Translational Medicine, Market Research and Project Management).
He/she participates on various committees and in the Clinical Development planning for assigned compounds in specific disease areas.
This position is based in our office in Zwijnaarde, Belgium.
Key Accountabilities/Responsibilities:

The Clinical Scientist will have the following key responsibilities:
  • Contact Key Opinion Leaders and perform/participate in advisory board meetings, in collaboration with the Clinical Research Physician (CRP)
  • Perform analysis of study data in order to develop a deep scientific understanding of our drug candidates
  • Participate in document template design and SOP writing.
  • Participate in the outreach for medical and regulatory advice Address any clinical / scientific issues arising from regulatory authorities and ethics committees.
  • Review and provide clinical and scientific input to the study protocol, Informed Consent Form (ICF), Statistic Analysis Plan, Monitoring Plans, Risk Management Plan, Case Report Forms (CRFs), edit specifications/checks, CRF completion guidelines, Study Charters and relevant regulatory documents, as required.
  • Ensure that clinical study milestones are aligned from a clinical / scientific perspective and consistent with the clinical program.
  • Identify membership and provide input into the charters of the Data Monitoring Committee (DMC), Steering Committee (SC) and other committees as required.
  • Participate and Present at external Investigator Meetings and at internal and external meetings.
  • Support the study team with scientific expertise at study site initiation and subsequent motivational visits, as required.
  • Perform ongoing resolution of issues arising from patient clinical management e.g. patient eligibility and study conduct.
  • Provide input into safety data reconciliation.
  • Assist in the identification and review of protocol deviations during study conduct.
  • Participate as a key meeting contributor in the DMC, SC, Clinical Data Review Plan, Risk Management and any related meetings, as appropriate.
  • Review and provide input into Clinical Study Reports and relevant clinical sections of the Investigator Brochure, as required.
Desired Skills and Experience:
  • Profound medical/scientific knowledge, especially in the fields of immunology, neurology, nephrology and/or hematology
  • Knowledge of clinical research, including basic statistics, pharmacodynamics and pharmacokinetics;
  • Ability to analyze and assimilate technical and scientific data and to apply knowledge;
  • Knowledge of GCP and ICH Guidelines;
  • Good written and oral English language skills;
  • Excellent communication skills;
  • Excellent interpersonal skills;
  • Detail-oriented and well-organized;
  • Relevant advanced scientific or medical degree (e.g. PhD, MD);
  • Experience in clinical research development or equivalent is a plus
Offer:
  • A competitive salary package with extensive benefits;
  • A work environment in a successful, dynamic, rapidly growing biotech company.
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Data limite: 10-01-2026

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