Staff Clinical Research Scientist

Leica Biosystems’ mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. We’re a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. Our associates know that every moment matters when it comes to cancer diagnostics. When you come to work, you’re helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people, and be inspired to grow every day.

Leica Biosystems is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges. 

The Staff Clinical Research Scientist for Leica Biosystems is responsible for developing and executing comprehensive clinical evidence plans to support global growth initiatives across multiple functions within Medical Device and IVD.

This position is part of the Global Clinical Affairs organization and will be on-site following the hybrid model at our Vista, CA OR Deer Park, IL locations. At Leica Biosystems, our vision is to advance cancer diagnostics and improve lives.

You will be a part of the Clinical Affairs Strategy team and report to the Director, Clinical Affairs. If you thrive in a dynamic clinical programs leadership role and want to work to build a world-class clinical trials organization—read on.

In this role, you will have the opportunity to:

• Apply Good Clinical Practice (GCP) expertise in the design of global evidence initiatives to support new product development, in vitro diagnostic device, medical device and companion diagnostic programs, pre- and post-market studies, and internal evidence development processes.

• Drive execution of clinical evidence strategy plans through synthesis of Voice of Customer requirements into recommended evidence investments for all priority products and markets to meet customer needs and drive market awareness/adoption.

• Lead the development of study design documentation – protocol writing, enrollment strategy, collaboration on statistical analysis plan, data management plan, monitoring plan, etc., as well as the delivery of robust study outcomes – data analysis and presentation to internal and external stakeholders, clinical performance study/clinical investigation report writing, and peer-reviewed publications.

• Collaborate with internal project stakeholders (Product Management, R&D, Regulatory, Quality, Medical Affairs, Design Transfer, etc.) and external partners (such as pharma, co-development collaborators and CROs).

• Support the clinical operations team with the conduct of clinical studies.

The essential requirements of the job include:

• Significant experience in evidence planning, clinical strategy, study design/execution and study monitoring for clinical diagnostics, medical devices, and/or pharmaceutical products in a regulated environment.

• Demonstrated experience in effectively negotiating with regulators (such as the U.S. Food and Drug Administration, European Medicines Agency, EU Notified Bodies) regarding high-classification clinical programs resulting in successful global commercial releases.

• Demonstrated ability to secure appropriate internal or external technical expertise required, build strong alliances, and coordinate efforts to resolve difficult technical and/or compliance issues that may arise during clinical trials.

• Demonstrated ability to understand complex scientific and business concepts.

It would be a plus if you also possess previous experience in:

• Oncology, histopathology, IHC RNA, ISH and DNA ISH assays and reagents, digital pathology imaging.

• Clinical research certification.

• A global matrix work environment

At Leica Biosystems we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work remotely from your home. Additional information about the work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Leica Biosystems can provide.

The salary range for this role is $150K-$170K (California). This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.