Clinical Scientist
Il y a 8 mois
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.
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)-
- Participate in the outreach for medical and regulatory advice Address any clinical / scientific issues arising from regulatory authorities and ethics committees.- Develop and conduct trial specific biomarker and translational research- 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 neurology, neurodegeneration, and/or immunology- Knowledge of clinical research, including basic statistics, pharmacodynamics and pharmacokinetics;-
- 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);- Knowledge of GCP and ICH Guidelines is a plus;- 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.
LI-Onsite
-
Clinical Scientist
Il y a 8 mois
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 4 mois
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 3 mois
Gent, Belgique Argenx Temps pleinJob 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...
-
Biostatistics & Bioinformatics Scientist
Il y a 8 mois
Gent, Belgique BioLizard Temps plein**Job description **Biostatistics & Bioinformatics scientist** **Who we are** BioLizard is a consultancy company providing bioinformatics, data science and data management solutions for our customers in biotech, pharma and diagnostics. Typically, a lizard adjusts to its surroundings. That is exactly what we do: we adapt to our customers’ data...
-
Senior Scientist Bioanalytical
Il y a 6 mois
Gent, Belgique Argenx Temps pleinFor the expansion of our Bioanalytical team, argenx seeks a highly motivated Senior Scientist in Bioanalytics with specialized expertise in immunogenicity assay development/validation for large molecules and/or clinical immunogenicity risk assessment and data interpretation. The Senior Scientist will spearhead the implementation of bioanalytical and...
-
Senior Scientist Bioanalytics
Il y a 6 mois
Gent, Belgique Argenx Temps pleinOperating under an outsourced model, argenx collaborates with bioanalytical vendors. The Senior Scientist will serve as the representative of the Bioanalytical team within one or multiple project teams, fostering close collaboration with internal and external stakeholders. Responsibilities include implementing bioanalytical strategies and contributing to...
-
Scientist Bioanalytics
Il y a 8 mois
Gent, Belgique Argenx Temps pleinargenx is a fast-growing clinical-stage biopharmaceutical company developing innovative potential therapies to help improve the lives of people suffering from severe autoimmune diseases. Our global team is committed to living by our values of collaboration, empowerment, humility, innovation and excellence. As we continue to expand our therapeutic franchises,...
-
Biomarker Associate Scientist
Il y a 2 mois
Gent, Belgique Argenx Temps pleinargenx is a fast-growing clinical-stage biopharmaceutical company developing innovative potential therapies to help improve the lives of people suffering from severe autoimmune diseases. Our global team is committed to living by our values of collaboration, empowerment, humility, innovation and excellence. As we continue to expand our therapeutic franchises,...
-
Scientist Discovery
Il y a 4 mois
Gent, Belgique Argenx Temps pleinFor the expansion of our Flowcytometry Expert Team, argenx is looking for a Supportive Scientist who oversees the activities related to flowcytometry, the organization of the flowcytometry CORE and implements developing state-of-the-art technologies. This position will be the primary scientific contact and will provide flowcytometry expertise and guidance...
-
Cmc Scientist
Il y a 6 mois
Gent, Belgique Argenx Temps pleinTo further strengthen our CMC team, we are looking for an experienced and motivated CMC scientist/ senior Scientist. The scientist/ senior scientist CMC will play a lead role supporting cell line development, drug substance (DS) manufacturing process development and analytical method development with external manufacturing partners (CMOs) to enable clinical...
-
Senior Scientist Purification/downstream Processing
Il y a 6 mois
Gent, Belgique Eurofins Belgium BioPharma Services Temps pleinCompany Description **Eurofins CDMO** is a leading international Contract Development and Manufacturing Organization (CDMO) based in Europe. Our company focuses on drug product development for chemical/biological entities and drug substance development for biologics. We support small and major biopharmaceutical companies in an innovative way to help them...
-
Associate Analytical Scientist
Il y a 6 mois
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,...
-
(Senior) Scientist Parenterals
Il y a 2 mois
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,...
-
Senior Scientist Cmc
Il y a 6 mois
Gent, Belgique MindCapture Temps pleinSENIOR SCIENTIST CMC - Biotechnology- GhentWHAT IS OFFERED - Competitive salary package with extensive benefits. - Opportunity to contribute to the development of therapeutic antibodies and make a tangible impact on patient care. - Dynamic work environment within a rapidly growing biotech company. - Collaborative culture that fosters creativity, innovation...
-
Senior Scientist Cmc
Il y a 7 mois
Gent, Belgique Argenx Temps plein1. PURPOSE OF THE FUNCTION A senior scientist CMC plays a key role supporting Chemistry, Manufacturing and Controls (CMC) development of Argenx drug products, ensuring that projects move forward in time and within budget. He/she drives internal and external efforts with the aim of developing, producing and characterizing these differentiated antibody...
-
Biomarker Scientist
Il y a 2 mois
Gent, Belgique Argenx Temps pleinargenx is a fast-growing clinical-stage biopharmaceutical company developing innovative potential therapies to help improve the lives of people suffering from severe autoimmune diseases. Our global team is committed to living by our values of collaboration, empowerment, humility, innovation and excellence. As we continue to expand our therapeutic franchises,...
-
Scientist for Customer Applications
Il y a 6 mois
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...
-
Group Leader Formulation
Il y a 6 mois
Gent, Belgique Ardena Temps plein**About us** As a leading contract development and manufacturing organization (CDMO) within the pharmaceutical industry, **Ardena** is dedicated to supporting pharmaceutical companies, from virtual biotech to major players, in bringing their valuable molecules to the clinic and market. Our commitment extends to providing a comprehensive and integrated...
-
Associate Scientist: Biochemical Analysis R&d
Il y a 6 mois
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...
-
Therapeutic Area Expert Cell
Il y a 8 mois
Gent, Belgique Cerba Research Nederland Temps plein**Who we are** We are Cerba Research and we provide the highest quality specialized laboratory and diagnostic solutions while leveraging patient data and scientific insight to shape and advance clinical trials. With our global footprint and access to leading regional labs, data, patients, technology, and partnered resources, we support global biotech,...