We are seeking a dynamic and experienced (Senior) Expert in Clinical Performance Studies to join our team, specializing in In Vitro Diagnostics (IVD). In this role, you will be designing, executing, and overseeing clinical performance studies for Companion Diagnostics (CDx) in vitro diagnostic (IVD) products. You will be ensuring that clinical performance studies are executed efficiently, accurately, and in accordance with established protocols, regulations contracts. You will play a key role in driving project success, maintaining high-quality standards, and building strong relationships with customers and partners.

If you're ready to make a significant impact in a role that combines scientific expertise, organizational skills, and customer engagement, we invite you to join our team and help us drive the future of clinical performance studies.

What do we expect from you as a Clinical Performance Studies Expert?

• Lead Clinical Performance Studies for CDx devices: Design, implement, and oversee clinical performance studies, ensuring that they meet both regulatory, scientific and contractual requirements.
• Build strong partnerships with key stakeholders to align study objectives with business goals and regulatory requirements.
• Collaborate with clinical, regulatory, and quality teams to initiate and conduct studies that meet both scientific and regulatory expectations.
• Ensure appropriate monitoring, data integrity, and reporting throughout the study lifecycle.
• Define, establish, and document a comprehensive process for planning and conducting clinical performance studies specific to CDx.
• Stay abreast of evolving regulatory requirements and guidance globally, ensuring processes are compliant with the latest standards.
•  Develop study protocols and project plans while ensuring alignment with project objectives, budget and regulatory requirements.
• Data Analysis & Reporting: Analyze complex clinical performance data, interpret results and draft high quality clinical performance study documentation.
• Regulatory Compliance: Ensure all studies are conducted in compliance with international regulations, including IVDR, ISO 20916, and other relevant guidelines.
• Training & Mentoring: Provide training and guidance to study sites and junior team members, fostering a culture of continuous learning and development within the team.
• Support our marketing activities, such as writing blogposts, white papers, present webinars, …

Who are we looking for?

• Bachelor’s, Master’s, or Ph.D. in a relevant scientific discipline (e.g., Biomedical Sciences, Biotechnology, Bioscience Engineering, ...)
• At least 10 (sr expert) / 5 (expert) years of experience with development activities of IVDs of which 2 in the field of Companion Diagnostics
• Strong knowledge of IVD clinical performance study design, and of the interplay between CDx performance studies and clinical trials
• Expertise in the field of oncology and precision medicine
• Demonstrated ability to collaborate with diverse teams and manage relationships across multiple stakeholders.
• Excellent written and verbal communication skills, with the ability to present complex information clearly and persuasively.
• Experience managing cross-functional projects from conception to completion, with strong organizational and time-management skills

A true QbD’er can be recognized by the following qualities:

• Resilient: Your strong and positive attitude helps you overcome any challenge
• Hungry for knowledge: You are always open to learning
• No non-sense mentality: you can be straightforward in a respectful way
• Innovative: You are constantly looking for new and better solutions
• (Not too) serious: your job is serious, but you don’t take yourself too serious.

What’s in it for you?

• QbD Group offers you an attractive and competitive salary package, that will be tailored to individual needs, considering legal requirements and local laws and regulations.
• Join us to build a sustainable career, where job security is ensured, and lasting, meaningful connections are formed.
• As we’re a knowledge-based company, you’re guaranteed to embark on a continuous journey of learning and development.
• Be part of our global success story. As an award-winning company we value everyone’s contribution and celebrate achievements together

Our promise to you:

• As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.
• Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals.
• In short … We stand for? JPEG: Joy in Partnership, going for the Extra mile to Get things done!
  

Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!