Clinical Scientist

argenx

Ghent, Belgium

Job Description

We are seeking a highly motivated Clinical Scientist to support our neuromuscular portfolio.

He/she will be the primary scientific contact for a neuromuscular indication and clinical study. He/she will provides clinical research expertise within the cross-functional team, during the clinical development of the asset.

This position is based in our facilities in Zwijnaarde (Ghent, Belgium).

What will you do:

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.
Assist in the identification and review of protocol deviations during study conduct.
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.
Provide input into safety data reconciliation.
Ensure that clinical study milestones are aligned from a clinical/scientific perspective and consistent with the clinical program.
Review and provide input into Clinical Study Reports.
Review and supports external content development such as Scientific posters, manuscripts.
Perform analysis of study data in order to develop a deep scientific understanding of our drug candidates.
Participate in the outreach for medical and regulatory advice.
Address any clinical/scientific issues arising from regulatory authorities and ethics committees.
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.
Contact Key Opinion Leaders and perform/participate in advisory board meetings, in collaboration with the trial physician.
Participate as a key meeting contributor in the Clinical Trial team (CTT), DRC, Clinical Data Review Plan, Risk Management and any related meetings, as appropriate.
Develop and conduct trial specific biomarker and translational research.

Who are you:

You are passionate about transforming patients' lives with innovative treatments. At argenx, you're empowered to take action and achieve critical milestones through collaboration. Curiosity, creativity, and science drive you to push boundaries and find solutions that make a real difference.

At argenx, we thrive on collaboration and a patient-centric approach, ensuring our work directly addresses unmet medical needs. We operate with accountability, integrity, and agility, acting swiftly and adapting to challenges with resilience.

We value continuous learning and encourage experimentation and growth, fostering an inclusive environment where creative problem-solving is key. Ownership and empowerment are central to our culture, giving you the freedom and responsibility to shape the future of medicine alongside a dedicated team.

Your Skills and Experience:

Relevant advanced scientific degree (PhD).
Profound medical/scientific knowledge, especially in the fields of neurology and/or neurodegeneration.
Experience in clinical research development or equivalent.
Knowledge of clinical research, including endpoints, basic statistics, pharmacodynamics and pharmacokinetics.
Ability to analyze and assimilate technical and scientific data and to apply knowledge.
Knowledge of GCP and ICH Guidelines is a plus;
Good written and oral English language skills.
Excellent writing and communication skills.
Detail-oriented and well-organized.

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