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Clinical Scientist

argenx
Arrondissement Gent, Oost-Vlaanderen
Full time
3 dagen geleden

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. 

For the expansion of our Clinical teams, argenx is looking for a highly motivated Clinical Scientist who will be responsible for the implementation of a clinical program to meet corporate and clinical research goals.
You will be the primary clinical/scientific contact for one or multiple clinical studies and will provide clinical research expertise within the cross-functional team (which includes Medics, Translational Research, Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory Affairs, Medical Affairs, Clinical Quality Assurance, Sample Management, Market Research, and Project Management).
You will operationalize the scientific aspects of the clinical trial protocol, combining clinical data and biomarker research on human samples, to improve the treatment of patients and advance our understanding of disease.
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.
 

This role is based in Zwijnaarde (Ghent) and requires regular presence in the office.
Please include your motivation for this position along with your CV.


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), Statistical Analysis Plan, Monitoring Plans, Risk Management Plan, Clinical Study Reports, Case Report Forms (CRFs), CRF completion guidelines, Study Charters, relevant regulatory documents, and other study-specific guidelines, as required
•    Support the study team with scientific expertise at study site initiation and subsequent monitoring visits, 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, to ensure data quality and consistency
•    Participate in outreach for medical and regulatory advice and address any clinical/scientific issues arising from regulatory authorities and ethics committees
•    Participate in and present at external Investigator Meetings and at internal and external meetings
•    Contact Key Opinion Leaders and participate in advisory board meetings, in collaboration with the trial physician
•    Provide input into safety data reconciliation
•    Ensure that clinical study milestones are aligned from a clinical/scientific perspective and consistent with the clinical program
•    Perform analysis of biomarker and clinical study data to develop a deep scientific understanding of our drug candidates
•    Review and support the development of external content such as scientific posters, manuscripts, etc
•    Co-develop and conduct trial-specific biomarker and translational research
 

Desired Skills and Experience:
•    Relevant advanced scientific degree; PhD preferred, but a Master's degree with at least 5 years of relevant industry experience will also be considered
•    Profound scientific knowledge, especially in the fields of neurology, neurodegeneration, neuromuscular diseases, endocrinology, and/or immunology
•    Knowledge of clinical research, including basic statistics, pharmacodynamics, and pharmacokinetics
•    Ability to analyze and assimilate technical and scientific data and apply knowledge
•    Strong communication skills with good written and oral English language proficiency
•    Excellent interpersonal skills
•    Detail-oriented and well-organized
•    Experience in clinical research development or equivalent is a plus
•    Knowledge of GCP and ICH Guidelines is a plus
 

Offer:
•    Full-time position in a collegial, dynamic, and growing company
•    A competitive salary package with extensive benefits
•    A work environment in a successful, dynamic, rapidly growing biotech company
•    Possibility to work remotely in combination with multiple scheduled working days per week onsite in Zwijnaarde (Ghent)

We plan to start scheduling the introduction interviews from August 7 onwards.

#LI-Onsite

At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.

Before you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates (“argenx”) will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at [email protected].

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