In Vitro Diagnostics Lead

il y a 1 semaine


Brainel'Alleud, Belgique UCB S.A. Temps plein

**Make your mark for patients.**

We’re here because we want to build the future and transform patients’ lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?

To strengthen our Device and Packaging team, we are looking for a high caliber, self-motivated**, In vitro Diagnosis Expert** based in** Braine 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.

**About us.**

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.

At UCB, everything we do start with a simple question: “How will this create value for people living with severe disease?”. We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.


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