In Vitro Diagnosis Expert
Ver: 144
Día de actualización: 21-03-2024
Ubicación: Bulle Fribourg FR
Categoría: Otra
Industria: Pharmaceutical Manufacturing
Posición: Mid-Senior level
Tipo de empleo: Full-time
Contenido de trabajo
To strengthen our Device and Packaging team, we are looking for a high caliber, self-motivated, In vitro Diagnosis Expert based inBraine l’Alleud, Belgium
At UCB everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” We do that by connecting our ground-breaking science with patients and their families around the world living with the physical and social burdens of autoimmune and neurological disorders. Those connections offer new perspectives, drive innovation, and offer the hope of a new generation of therapies that will help improve lives on a global scale.
You like to work in an environment where you will be:
- Responsible for delivering necessary IVD biomarker solutions for the assigned programs
- Drive IVD biomarker adoption in clinical studies and provide necessary support to UCB’s clinical development teams and CROs
- Promote IVD awareness and good practices
- Work closely with Early Solutions Translational Medicine Biomarker and global clinical development teams and identify the biomarkers requiring development as IVD medical devices. Identify gaps in relation to TPVP and clinical study design and recommend additional IVD biomarker discovery efforts.
- Drive IVD biomarker adoption in clinical studies and provide necessary support to UCB’s clinical development teams and CROs
- Actively engage with Medical Device Regulatory Affairs, Quality Assurance, Safety, functions to ensure the biomarkers meet cross-functional requirements and are compliant
- Drive and/or support partnership contracting with biomarker technology companies. Manage day-to-day technical engagement with the partners
- Engage with academic, clinician or patient bodies on necessary research
Interested? For this position you’ll need the following education, experience and skills:
- Experience in IVD biomarkers is essential. Hands-on experience in companion diagnostics is highly desirable.
- Experience in the regulatory aspects of IVD biomarkers is essential.
- Experience in the technical aspects of molecular biology technologies is highly desirable.
- Pharmaceutical business experience and familiarity with competitive landscape of devices and pharmaceuticals, drug development process, regulatory requirements, and market access/reimbursement processes
- Experience in Gene Therapy/Cell Therapy is a plus
- Proven track record in project management
- Experience working in internal and external project teams
- Experience working in strategic projects and initiatives
- Experience in global projects, ideally with USA or EU operational experience
- Experience in evaluating external projects and technologies
Why you should apply
At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.
If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.
Plazo: 05-05-2024
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