Clinical Scientist

Clinical Scientist

argenx

Ghent, Belgium

As part of the expansion of our neuromuscular clinical team, argenx is seeking a Clinical Scientist to direct the strategy, planning, and implementation of clinical programs that align with our corporate and clinical research goals.

The Clinical Scientist will act as the primary clinical and scientific contact for one or more clinical studies, providing expertise within a cross-functional team that includes Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory Affairs, Clinical Quality Assurance, Translational Medicine, Market Research, and Project Management.

This role also involves participation in various committees and contributing to clinical development planning for assigned compounds in specific disease areas. You will operationalize the scientific aspects of clinical trial protocols, integrating clinical data and biomarker research on human samples to improve patient treatment and advance our understanding of disease.

You are passionate about transforming patients’ lives through innovative treatments. At argenx, you’re empowered to take initiative and achieve critical milestones through collaboration. Curiosity, creativity, and science drive you to push boundaries and deliver meaningful solutions.

Key Accountabilities/Responsibilities

The Clinical Scientist will be responsible for:

• Engaging Key Opinion Leaders and participating in advisory board meetings, in collaboration with the medical lead;
• Reviewing and providing clinical and scientific input to study documents, including protocols, Informed Consent Forms (ICFs), Statistical Analysis Plans, Monitoring Plans, Risk Management Plans, Clinical Study Reports, Case Report Forms (CRFs), CRF completion guidelines, Study Charters, regulatory documents, and other study-specific guidelines, as required;
• Providing scientific expertise to the study team during site initiation and subsequent monitoring visits, as needed;
• Assisting in identifying and reviewing protocol deviations during study conduct;
• Resolving issues arising from patient management (e.g., eligibility, study conduct) to ensure data quality and consistency;
• Contributing to medical and regulatory interactions and addressing clinical or scientific questions from regulatory authorities and ethics committees;
• Participating in and presenting at Investigator Meetings, as well as internal and external meetings;
• Providing input for safety data reconciliation;
• Ensuring clinical study milestones are scientifically sound and aligned with overall clinical program goals;
• Reviewing and supporting the development of external scientific content, such as posters and manuscripts;
• Co-developing and conducting trial-specific biomarker and translational research to deepen the scientific understanding of our drug candidates.

Desired Skills and Experience

• Advanced scientific degree (PhD) with relevant industry experience;
• Profound scientific knowledge, particularly in neurology, neurodegeneration, and/or neuromuscular diseases;
• Experience in clinical research development;
• Understanding of clinical research principles, including basic statistics, pharmacodynamics, and pharmacokinetics;
• Strong analytical skills and ability to assimilate and apply technical and scientific data;
• Excellent communication skills, with strong written and spoken English proficiency;
• Strong interpersonal skills;
• Detail-oriented and well-organized;
• Knowledge of GCP and ICH guidelines is an advantage.