Clinical Scientist
il y a 2 jours
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
- 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
- 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 envi
-
Clinical Scientist
il y a 2 jours
Gent, Belgique Argenx Temps pleinFor 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...
-
Clinical Scientist
il y a 3 heures
Gent, Belgique Argenx Temps pleinFor 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...
-
Clinical Scientist
il y a 2 jours
Gent, Belgique Argenx Temps pleinFor 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,...
-
Clinical Science Coordinator
il y a 2 jours
Gent, Belgique Argenx Temps pleinJoin 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...
-
Scientist for Customer Applications
il y a 3 heures
Gent, Belgique Oxford Global Resources Temps pleinLocation: Ghent, Belgium - Contact: Dardo Helpers - Job type: Permanent - Contact phone: +32 15 445 852 - Industry: Medical Device & Diagnostics You have a background in the biomedical or bio-engineering field? Use your knowledge in u customer forward position, communicating and aiding end users of specialised pre-clinical equipment. **Job...
-
Senior Scientist
il y a 2 jours
Gent, Belgique Eurofins Belgium BioPharma Services Temps plein**Company Description** Eurofins CDMO is a leading international Contract Development and Manufacturing Organization (CDMO) based in Europe. Our company focuses on drug product development and manufacturing for chemical/biological entities and drug substance development and manufacturing for biological entities. We support small and major biopharmaceutical...
-
Principal Investigator Positions in Inflammation Research
il y a 4 heures
Gent, Belgique VIB Temps pleinThe **VIB Center for Inflammation Research (IRC)** is seeking **2-3 outstanding Principal Investigators** to establish ambitious and independent research groups in the broad field of **inflammation biology**. We welcome scientists with innovative, high-impact ideas that **complement and expand IRC’s expertise**. **About VIB & IRC**: The **VIB Center for...
-
(Associate) Director Bioanalytics, Franchise Lead
il y a 2 jours
Gent, Belgique Argenx Temps pleinFor the expansion of the bioanalytical team, argenx is looking for a (Associate) Director Bioanalytics, with profound experience in late-stage drug development of large molecules. The level and title will depend on the experience of the incumbent. He/she will conduct and lead bioanalytical support in all aspects for one of the argenx indication franchises....
-
Senior Data Scientist
il y a 2 semaines
Gent, Belgique myNEO Temps pleinWe are continuously on the look-out for interesting profiles. Be invited to send in your CV and we will review it for future open positions!_ Are you passionate about actively helping in implementing new personalised cancer treatments, alongside accomplished biotech experts? Are you looking for an ambitious new project to test and grow your...
-
Group Leader Analytical Sciences
il y a 2 semaines
Gent, Belgique Ardena Temps plein**About us** **Ardena** is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing,...