Overview
In this role you lead medical and clinical efforts to develop novel diagnostic and companion diagnostic assays and platforms for precision medicine at Leica Biosystems. You will guide cross-functional teams on pathology input, R&D projects, clinical studies, and regulatory submissions, shaping strategies to advance cancer diagnostics and pharma collaborations. You will act as a medical thought leader, educating internal teams and external partners while building Leica’s presence as a pharma partner. This hybrid site role in Newcastle provides the chance to impact patient outcomes through innovative diagnostics.
Pay / Benefits
- remote work arrangement
- flexible working arrangements
- comprehensive benefits
- paid time off
Responsibilities
- Direct R&D projects, clinical studies and regulatory submissions for diagnostic and companion diagnostic assays
- Provide pathology input to cross-functional teams and projects related to novel diagnostics
- Offer strategic medical insights to prioritize new product development based on clinical value
- Support pharma partnerships and evidence generation for companion diagnostics
- Promote Leica Biosystems as a pharma partner and thought leader in advanced assays
- Deliver internal and external education on new technologies through conferences, webinars, and site visits
- Contribute to assay design specifications, IVD and CDx study design, and regulatory strategy/submissions
- Participate in regulator meetings (e.g., FDA) and review marketing materials
- Provide medical input to device risk analyses, health hazard evaluations, and risk/benefit reporting
- Collaborate with internal teams to cultivate relationships in pathology practice and pharma to drive growth
Key requirements
- PhD-qualified Pathologist with published work
- FRCPath Parts 1 and 2 board certification in Histopathology
- Full GMC registration and Specialist Register in Histopathology
- >2 years of experience in diagnostics, biopharma, medical devices or related industry
- Experience in developing in vitro diagnostic products and interactions with regulatory agencies
- Strong written and verbal communication
- Ability to influence and act as a change agent
- Relationship management and cross-functional collaboration
- Computational pathology and clinical informatics
- Machine learning and artificial intelligence as applied to digital pathology
- Regulatory strategy and submissions for IVD/CDx
Medical Director, Companion Diagnostics and Advanced Assays employer: Danaher Corporation
Abcam is an exceptional employer that prioritises the well-being and professional growth of its employees. Located in the vibrant city of Cambridge, the company fosters a collaborative work culture where innovation thrives, offering numerous opportunities for career advancement and skill development. With a strong commitment to environmental health and safety, Abcam provides a meaningful work environment where you can make a real impact while enjoying a supportive team atmosphere.
