This role within the Clinical Science team of Clinical Affairs will serve as a Clinical Expert contributing towards gathering clinical evidence and presenting it to regulatory bodies in support of the In-vitro Diagnostic (IVD) product range within QIAGEN, primarily focused on the Oncology portfolio. The post-holder is accountable for managing performance evaluation for IVDs as well as contributing to clinical strategy, study protocols, study reports and post market surveillance activity. The post-holder will coordinate the efforts and activities of diverse internal and external stakeholders, ensuring compliance with organizational SOPs and international regulations.
– Managing the delivery of clinical/performance evaluation plans, scientific validity reports clinical/performance evaluation reports to support Global Clinical Affairs activities around medical device (MD)/IVD development, registration and marketing, ensuring accuracy of information, data and referencing for the documents produced.
– Manage external contractors and vendors, ensuring projects are delivered within budget and to timeline.
– Collaborate with internal project stakeholders (including but not limited Medical Affairs, Product Development, Quality, Regulatory) and external partners.
– Review/contribute to non-clinical QIAGEN documents and represent Clinical Affairs on multi-functional teams to ensure requirements are met for IVDR/FDA and ROW compliance.
– Update, review and contribute to SOPs and drive continuous improvement within the Clinical Affairs team including training other staff and representing QIAGEN in industry working groups.
– Master’s degree (preferably PhD) in Life Sciences with a minimum 3 years’ employment experience with in vitro diagnostic devices and/or a clinical setting. Experience within oncology and/or companion diagnostics is preferred.
– Working knowledge of regulatory requirements and clinical practice guidelines e.g. FDA CFR, ICH GCP, ISO20916, ISO14971, ISO13485, MDR, IVDR, MedDev, MDCG, CLSI guidelines, CTS, GHFT/IMDRF.
– Good understanding of project management, proficiency in prioritizing work under tight and challenging deadlines within budget and in compliance with organizational SOPs and international regulations.
– Willingness and availability to travel nationally and internationally: 10-20%.
– Proficient in reading, analyzing and interpreting scientific and technical information, learning and understanding new therapeutic areas quickly and comprehensively.
What we offer
At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.
– Possibility to develop in an international company
– Attractive pension
– Private Healthcare
– Private Dentalcare
– Gym membership contribution
– Access to an Employee Assistance Programme
– A range of retail discounts and offers
– Opportunity to join internal QIAGEN communities
– Enhanced maternity package
– Flexible working options
– 25 days annual leave (potential to increase linked to service)
QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.
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