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 Medical Director, Companion Diagnostics and Advanced Assays for Leica Biosystems is responsible for providing medical and clinical leadership in the development of novel diagnostic and companion diagnostic assays and platforms to support precision medicine initiatives, positioning Leica Biosystems (LBS) as cutting-edge cancer diagnostics provider and pharma partner.
This position is part of the Medical and Scientific Affairs and will be fully remote. At Leica Biosystems, our vision is to advance cancer diagnostics and improve lives.
You will serve as critical leader for the teams involved in the development of Advanced Assays, Companion Diagnostic and Pharmaceutical Partnerships, and you'll be expected to provide pathology input to cross-functional teams and projects related to novel diagnostics. The role reports to the Senior Medical Director, Companion Diagnostics. If you thrive in a fast-paced, global role and want to work to build a world-class Diagnostics and Companion Diagnostics platform at LBS-read on.
In this role, you will have the opportunity to:
- Partner cross-functionally to collect, evaluate and communicate key clinical, medical and scientific data. You will be the Subject Matter Expert to direct R&D projects, clinical studies, and regulatory submissions in support of diagnostic and companion diagnostic assays. You will be responsible for providing strategic insight to support new product development and innovation opportunities, prioritizing opportunities based on clinical value and strong medical understanding of pharma, physician and patient needs.
- Actively support pharma partnerships (companion diagnostics), clinical evidence generation partnerships, and strategic growth efforts through collaboration with internal teams and cultivation of relationships in pathology practice (academic and community) and pharma.
- Play an integral role in building LBS’s brand as a pharma partner and thought leader in advanced assays. Provide internal and external education and expertise to support product innovation and market adoption of best practices and new technologies in a variety of settings, including conferences, webinars, and site visits.
- Provide pathology expertise and medical insight for the development of assay design specifications; design and execution of IVD and CDx studies; creation of training materials and interpretation guides; contribution to regulatory strategy and submissions; participation in meetings with regulators (e.g. FDA); review of marketing and promotional materials.
- Provide medical input to device risk analyses, health hazard evaluations (HHE), adverse event review, and risk/benefit reporting.
The essential requirements of the job include:
- M.D. degree
- American Board of Pathology certification in Anatomic Pathology (AP) (for US applicants) or FRCPath Parts 1 and 2 in Histopathology (for UK applicants)
- >4 years of experience in diagnostics, laboratory, biopharma, medical device, or related industry.
- Experience in the development of in vitro diagnostic products including interactions with regulatory agencies.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
- Ability to travel – 30% travel, including international
It would be a plus if you also possess previous experience in:
- Additional training in pathology subspecialty such as molecular genetic pathology, hematopathology, or clinical informatics; other organ-specific Histopathology specialty training in area such as GI, GU, or breast.
- Experience in computational pathology and clinical informatics, machine learning, and artificial intelligence as applied to digital pathology research and practice.
- Experience with risk management / safety assessment in medical device or biopharmaceutical industry.
- Experience with product development and/or business development and strategy in medical device or biopharmaceutical industry.
At Leica Biosystems we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote 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 US $200,000 – 250,000/UK $125,000-150,000. 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.
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.
