Clinical Operations Lead
il y a 6 heures
**11 FEB ’22**:The organisation is a clinical-stage Biopharmaceutical organisation focused on the discovery and development of innovative liver biotherapeutics and currently looking for a Clinical Operations Lead. These therapeutics are based on the human microbiome and is based on a ‘Center of Expertise’ for microbiome research and development in the biotech cluster in Ghent, Belgium. At the moment, they are looking for their first Clinical Operations lead to join and reinforce the Clinical Development team, where you translate pre-clinical and translational research into novel and differentiating products and, ultimately, breakthrough microbial strategies for the treatment of conditions associated to impaired intestinal health and immune, metabolic or CNS diseases.
Details
- Biotechnical
- Clinical Research
- Ghent
- 40 hours p/week
Leer ons kennen
**Jouw consultant**:
- Aron Berhane
- +31 23 754 86 60
Over jouw rol
**Zo maak jij het verschil**:
As the Clinical Operations Lead, you will have the opportunity to become a key team member in the organisation’s clinical development team to bring breakthrough live bacterial consortia to the patient in different diseases with high unmet medical needs. The focus will be on the clinical program related to gut-inflammation-associated disorders but you will also be closely involved in the progression to the clinic of other pipeline programs.
The responsibilities won’t stop there as you will be working on the operational aspects during the planning, start-up, conduct and close-out phase of the given trials while ensuring the quality and integrity of the data. This in addition to act as a first point of contact for clinical operations related questions for the several trials you work on. To make sure everything goes as planned, you will contribute to timely development and review of trial-specific documentation, provide updates on trial evolution to the clinical development team and ensure the timely selection and qualification of CRO’s and vendors, their training and management throughout the study to ensure timely and quality deliverables.
Wat nodig is
**Wat jij mee brengt**:
- At least a Bachelor degree in a medical or biomedical discipline
- Excellent knowledge of ICH, European directives and FDA guidelines related to GCP
- Strong experience with clinical development processes where known with immunology, gut, auto-immune diseases or living biological products will be seen as an asset
- Good organisational skills for seamless interactions with Study Teams, Investigators, Clinical staff, Vendors etc. Team player with good communication skills, personal leadership in matrix teas, flexibility and resilience, positive approach, forward thinking, conflict handling and problem solving skills, sense of innovation. Willing and capable to go the extra mile if needed.
- Fluent in Dutch and English, both in written speech
Wat wij bieden
**Jouw voordelen**:
The organisation is also able to offer you the following:
- Annual base salary between €60,000 and €75,000 including holiday allowance and 13th month
- Competitive package with fringe benefits
- Excellent personal and growth package
Terug naar het vacatureoverzicht
-
Clinical Operations Excellence Lead
Il y a 2 mois
Gent, Belgique Argenx Temps pleinROLES AND RESPONSIBILITIES: - Ensure oversight of the adequacy of processes in Global Clinical Operations. Ensure regulatory requirements and commitments are reflected in the procedural documents - Identify and drive continuous improvement of processes and systems within Global Clinical Operations organization - Ensure quality risk management principles are...
-
Clinical Operations Excellence Lead
Il y a 7 mois
Gent, Belgique Argenx Temps pleinThis position reports into the Head Clinical Operations Excellence. We want to fill in the position in Europe or the United States. Roles & Responsibilities - Ensure oversight of the adequacy of processes in Global Clinical Operations. Ensure regulatory requirements and commitments are reflected in the procedural documents. - Identify and drive continuous...
-
Clinical Operations Development Lead
Il y a 7 mois
Gent, Belgique Argenx Temps pleinWe are currenty looking for a Clinical Operations Development Lead (CODL) to strengthen the Global Clinical Trial Operations team. - The Clinical Operations Development Lead is responsible for the oversight of the clinical related activities within a specific therapeutic indication for an asset (CODL) or across all indications for an asset (X-indication...
-
Clinical Operations Lead
il y a 2 semaines
Gent, Belgique MRM Health Temps plein**Clinical Operations Lead** **Company Overview** **Position description** MRM Health is looking for a Clinical Operations Lead to join and reinforce its Clinical Development Team in Ghent, Belgium, and translate pre-clinical and translational research into novel and differentiating products and, ultimately, breakthrough microbial strategies for the...
-
Clinical Operations Development Lead
Il y a 4 mois
Gent, Belgique Argenx Temps pleinFor the expansion of our Global Clinical Trial Operations team, argenx is looking for a Clinical Operations Development Lead. Key Accountabilities/Responsibilities: The Clinical Operations Development Lead (CODL) is responsible for the oversight of the clinical related activities within a specific therapeutic indication for an asset (CODL) or across all...
-
Clinical Operations Development Lead
Il y a 7 mois
Gent, Belgique Argenx Temps pleinDue to the exponential growth of argenx worldwide, we are currently looking for several _Clinical Operations Development Leads (CODL) _to strengthen the Global Clinical Trial Operations team. Ideally, location would be based in Belgium._ - The Clinical Operations Development Lead is responsible for the oversight of the clinical related activities within a...
-
Clinical Operations Development Lead
il y a 2 semaines
Gent, Belgique Argenx Temps pleinThe Clinical Operations Development Lead (CODL) is responsible for the oversight of the clinical related activities within (a) specific therapeutic indication(s) (CODL) or across asset indication (X-indication CODL). Together with the Medical Development Lead (MDL), the CODL co-leads the Clinical Development Team (CDT) and co-owns the Clinical Development...
-
Franchise Clinical Operations Development Lead
Il y a 9 mois
Gent, Belgique Argenx Temps pleinTo strengthen our Global Clinical Trial Operations team, we are currently looking for a Franchise Clinical Operations Development Lead (Franchise CODL). The Franchise CODL is responsible for the strategizing, planning, leading and execution of the operational path for all indications within a franchise from first in human studies through authorization and...
-
Clinical Trial Lead
Il y a 4 mois
Gent, Belgique Argenx Temps pleinThe Global Clinical Trial Operations team is expanding and is looking for a Clinical Trial Lead. - The Clinical Trial Lead (CTL) is a cross-functional leader with global accountability for all operational deliverables of clinical studies from Final Protocol Concept Sheet to Clinical Study Report (CSR) and applicable results disclosure. The CTL provides...
-
Clincal Development Operations
Il y a 7 mois
Gent, Belgique Meet Recruitment Temps plein110000 EUR - 110000 EUR - Ghent, Belgium - Permanent **About**: Our client is a leading, innovative biotechnology company dedicated to developing cutting-edge antibody products to transform patients' with autoimmune disease lives. They are at the forefront of the immunology space, pioneering groundbreaking treatments for various diseases. Their mission is...
-
Clinical Trial Manager
Il y a 4 mois
Gent, Belgique Argenx Temps pleinTo support the expansion of our Global Clinical Trial Operations team, we are currently looking for a Clinical Trial Manager. - The Clinical Trial Manager (CTM) operates cross-functionally with global accountability for operational deliverables of clinical studies from Final Protocol Concept Sheet to Clinical Study Report (CSR) and applicable results...
-
Clinical Operations Manager
il y a 3 jours
Gent, Belgique Workplace Options Temps pleinFounded in 1982, WPO is the largest independent provider of holistic wellbeing solutions. Through our customized programs, and comprehensive global network of credentialed providers and professionals, we support individuals to become healthier, happier and more productive both personally and professionally. Trusted by 51% of Fortune 500 companies, we deliver...
-
Clinical Operations Manager
il y a 3 jours
Gent, Belgique Workplace Options Temps pleinFounded in 1982, WPO is the largest independent provider of holistic wellbeing solutions. Through our customized programs, and comprehensive global network of credentialed providers and professionals, we support individuals to become healthier, happier and more productive both personally and professionally. Trusted by 51% of Fortune 500 companies, we deliver...
-
Clinical Scientist
Il y a 9 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 9 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 5 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...
-
Operations Readiness Lead Tl Phase 2
Il y a 3 mois
Gent, Belgique Johnson & Johnson Temps pleinJohnson & Johnson is currently seeking an Operations Readiness Lead to join our highly engaged team located in Ghent. Do you want to contribute to the manufacturing of innovative, life-changing cell therapy products for our patients and be part of an inclusive team at Johnson & Johnson Innovative Medicines Supply Chain Ghent? As Operations Readiness Lead...
-
Car-t Operations Support Lead
Il y a 7 mois
Gent, Belgique Legend Biotech EU Temps plein**Company Information** Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma. **ROLE OVERVIEW** The CAR-T Operations...
-
Patient Recruitment
Il y a 7 mois
Gent, Belgique Argenx Temps pleinThis role is part of the Site and Patient Engagement team within Trial Operations at argenx. The Patient Recruitment & Retention Strategy Lead encompasses strategic leadership and oversight of patient recruitment efforts across multiple clinical trials/indications across argenx This role will work with the global clinical team and leaders to understand...
-
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...