Clinical Development Leader
il y a 2 semaines
Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices across Europe and headquartered in Belgium (Mechelen) . We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happeners’. We are looking for a Clinical Development Leader to join our team in Basel (Switzerland) or Mechelen (Belgium). Scope of the job Physician leading the creation and execution of the clinical development plan for drug candidates at Galapagos. Your role Lead the Clinical Development Team to define the clinical development strategy as well as design and execute the Clinical Development Plan from FIH through registration according to approved plans including budget and timelines Drive the process of expanding the indication spectrum beyond the initial indication by building a strong preclinical and clinical rationale for additional diseases or conditions Support the identification of opportunities to grow & sustain the GLPG portfolio Provide scientific guidance and contribute to regulatory interactions including applications for marketing authorization Contribute, review, and approve Briefing documents and the IB and contribute and review IMPD, study protocol, CSR and other documents Closely collaborate with multidisciplinary project team members and other subject matter experts Oversee and manage the interactions with external experts, collaborators, alliance partners, participate in Due Diligences Participate to the safety management team and contribute to the risk assessment and mitigation strategy for drug candidates in all phases of clinical development Support to attract, retain and develop top talent for the Clinical Development group Line Manager role (as applicable) Function as Clinical Program Head (CPH) delegate (as applicable)
-
Business Development Manager – Western Europe
il y a 2 semaines
Mechelen, Belgique SGS Temps pleinJob DescriptionYour MissionAs our Business Development Manager, you’ll be the driving force behind identifying and securing new business opportunities in the (bio)pharmaceutical sector. You’ll build strong relationships, close impactful deals, and help shape the future of clinical research at SGS.What you’ll do: Lead business growth by identifying...
-
Head of Preclinical Safety Leaders
il y a 2 semaines
Mechelen, Belgique Galapagos Temps pleinPleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices across Europe and headquartered in Belgium (Mechelen) . We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to...
-
Medical Writing Leader
il y a 2 semaines
Mechelen, Belgique Galapagos Temps pleinPleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in US, headquartered in Mechelen, Belgium. We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We pioneer...
-
Senior Clinical Affairs Specialist
il y a 2 semaines
Mechelen, Belgique Nipro Europe Group Temps plein: You will be working in a team that develops clinical evaluation reports (CERs) per MEDDEV 2.7.1 Rev 4 and MDR regulations (MDCG 2020-6). Your work will support CE Mark applications, recertifications, and proposed indication/labeling changes, ensuring EU product conformance. You will also develop and review Post Market Clinical Follow-up (PMCF) strategies,...
-
Head of Clinical Project Management
il y a 2 semaines
Mechelen, Belgique SGS Temps pleinJob DescriptionYour MissionAs HCPM, you’ll be the driving force behind our clinical project management team. You’ll lead, coach, and empower Clinical Project Managers to deliver high-quality research projects that truly make a difference. You’ll collaborate closely with senior leadership to ensure optimal resource allocation, training, and strategic...
-
Head of Clinical Project Management
il y a 1 semaine
Mechelen, Belgique SGS Temps pleinJob DescriptionYour MissionAs HCPM, you’ll be the driving force behind our clinical project management team. You’ll lead, coach, and empower Clinical Project Managers to deliver high-quality research projects that truly make a difference. You’ll collaborate closely with senior leadership to ensure optimal resource allocation, training, and strategic...
-
Key Account Manager
il y a 2 semaines
Mechelen, Belgique SGS Temps pleinJob Description Your Role: Key Account Manager – Clinical ResearchAs a Key Account Manager, you’ll be the trusted partner for a select group of strategic clients. You’ll drive growth, build long-term relationships, and act as the vital link between our clients and SGS’s global Clinical Research Organization.What You’ll Do:Be the go-to contact for...
-
Business Development Manager Biometrics
il y a 2 semaines
Mechelen, Belgique SGS Temps pleinJob DescriptionAs Business Development Manager you will be responsible for identifying and exploring strategic business development opportunities with a focus on biometrics activities within the Clinical Research business to maximize organization growth.Concretely this means:that with your extensive knowledge of current market evolutions and conditions you...
-
Senior Clinical Affairs Specialist
il y a 1 jour
Mechelen, Belgique Science Talents Temps plein**Introductie**: To reinforce our client's clinical affairs team we are looking for a Senior Clinical Affairs Specialist - Medical Devices. **Jobomschrijving**: Clinical Evaluation (35%) - Develop and maintain Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) - Perform systematic literature reviews to support clinical evaluations and...
-
Clinical Trial Assistant
il y a 1 jour
Mechelen, Belgique SGS Temps plein**Company Description** SGS is a place to learn, develop and grow your full potential with career opportunities across different sectors and services that help to create a better world. Share our ambition to enable a better, safer, and more interconnected world and be active in almost every industry, touching nearly every area of human activity! In the...