(Senior) Clinical Study Lead - Companion/ Complementary Diagnostics

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, 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.

This is a Global role, we are looking for a candidate to be located within UK, EU, USA or Canada.

The (Senior) Clinical Study Lead (CSL) serves as a key member of the project core team with the goal to significantly contribute towards efficient launch of new or improved products.

Key responsibilities:

- Study design, strategy, planning (timeline, required resources and budget) for QIAGEN sponsored clinical studies. Lead a clinical sub-team and coordinate activities with internal and external stakeholders e.g pharma partners, central labs, test sites and provide regular status updates.

- Development and execution of all study associated documentation including protocols, investigator brochure, informed consent, contracts and clinical study reports.

- Coordinate site management activities e.g study startup and site preparation, compliance, close out procedures. Work with stakeholders e.g Product Development, Statistics, QA, Regs etc to ensure compliance with relevant regulations, guidelines and SOPs.

- Oversight of performance study applications for compliance with IVDR and other regulatory requirements. Support submission and addressing of RFIs from NCA/ECs. Support submission of documents to regulatory authorities, IRBs and local agencies in line with their requirements and respond to queries.

- Support during audits e.g. BIMO, pharma partner, FDA

- MSc in Life Sciences, Biomedical Engineering or similar; or equivalent experience. PhD is preferred.

- Significant employment experience within an in vitro diagnostic devices company, ideally in a Clinical Affairs related role; other devices or pharmaceutical experience will be considered. Experience with companion/ complementary diagnostics would be highly preferable.

- Working knowledge of regulatory requirements and industry working practices e.g. FDA CFR, ICH GCP, ISO14155, ISO20916, ISO13485, IVDR, CLSI guidance, design control.

- Understanding of electronic Data Capture (eDC), eTMF and Clinical Trial Management System (CTMS) or similar clinical operations systems.

- Experience of authoring clinical study documents e.g. Protocols, Investigator Brochure, Informed Consent Documents is desirable.

- Willingness and availability to travel nationally and internationally as required: up to 10%

The estimated base salary range for this position is $100,000 - $140,000. Compensation will be based on the candidate's experience, skills, geographic location, and other job-related factors. In addition to base salary, we offer a total compensation package that includes a bonus plan and generous benefits.

- Bonus/Commission
- Local benefits
- Referral Program
- Volunteer Day
- Internal Academy (QIALearn)
- Hybrid work (conditional to your role)
- Employee Assistance Program and internal QIAGEN communities

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 an inclusive 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.