QIAGEN
Clinical Study Lead – In Vitro Diagnostics
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Overview
At QIAGEN, we are driven by a simple but powerful vision: making improvements in life possible.
We’re dedicated to revolutionizing science and healthcare for the better. From our entrepreneurial roots to our current global presence, we've grown into a force for positive change. With thousands of employees across six continents, collaboration is our greatest strength. We’re always striving to identify talented individuals to join our exceptional teams.
We have played a pivotal role in shaping modern science and healthcare, and we're just getting started. If you're someone who thrives on new challenges, values diversity and wants to make a tangible difference in people's lives, then QIAGEN is the place for you.
At QIAGEN, every day is an opportunity to make a real-life impact.
Join us, grow with us, and together, let's shape the future of biological discovery.
About The Opportunity
Join QIAGEN as a Clinical Study Lead (CSL) and play a pivotal role in bringing innovative in vitro diagnostic (IVD) solutions to market within our Oncology and Biopharma Companion Diagnostics portfolio. In this position, you will lead global clinical performance studies that support the development and regulatory approval of cutting-edge diagnostics that directly impact patient outcomes.
Working within a cross-functional, international environment, you will collaborate closely with pharmaceutical partners, clinical sites, and internal stakeholders to ensure studies are delivered to the highest scientific, regulatory, and operational standards. This is an opportunity to influence high-impact clinical programmes while collaborating with world-class partners and contributing to meaningful advancements in precision medicine.
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Your tasks
- Lead the design, strategy, and planning of QIAGEN-sponsored clinical performance studies, including timelines, resource allocation, and budget.
- Develop and execute all study documentation (protocols, investigator brochures, informed consent forms, contracts, and reports) in line with regulatory requirements and internal SOPs.
- Oversee site selection, study start-up, conduct, and close-out, coordinating with CTAs, CRAs, and cross-functional teams to deliver high-quality clinical validation for companion diagnostics.
- Author clinical study reports and regulatory submission documents for health authorities, IRBs, and local agencies; manage responses to regulatory queries.
- Ensure compliance with global regulatory frameworks, including FDA and IVDR requirements, and collaborate with internal and external stakeholders to meet regulatory deliverables.
- Support internal and external audits as required.
Your profile
- Advanced degree in Life Sciences, Molecular Biology, Biomedical Engineering, or related field; PhD or equivalent experience preferred.
- Proven experience within an in vitro diagnostics (IVD) organisation, ideally in Clinical Affairs or Clinical Operations. Experience in oncology and/or companion diagnostics is highly desirable.
- Demonstrated experience authoring clinical study documents such as protocols, investigator brochures, and informed consent forms.
- Strong working knowledge of regulatory and industry standards, including FDA CFR, ICH GCP, ISO14155, ISO20916, ISO13485, IVDR, and CLSI guidance.
- Familiarity with clinical operations systems such as eDC, eTMF and CTMS.
- Ability and willingness to travel internationally up to 20% to support global study activities.
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What We Offer
- Attractive pension
- Private Healthcare and Dentalcare
- Gym membership contribution
- A range of retail discounts and offers
- Enhanced maternity package
- Flexible working options
- Bonus/commission
- 25 days annual leave (potential to increase linked to service)
- Employee Assistance Program and internal QIAGEN communities
- Hybrid work (conditional to your role)
Our people are the heartbeat of everything we do. Passion drives us as we push boundaries to innovate and evolve. We inspire with our leadership and make an impact with our actions. We cultivate a collaborative, supportive environment where each individual and team can flourish. We champion accountability and encourage entrepreneurial thinking.
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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