CDx Strategy Lead — Associate Director

BioSpace; North Chicago (IL); On-site; USD 180,000 - 240,000; Full time

Job summary

AbbVie seeks an Associate Director, Companion Diagnostics Strategy Lead to advance global diagnostic strategies supporting CDx development across oncology, immunology, and neuroscience. You will work in a highly collaborative, multidisciplinary setting and guide co-development with external partners to meet project timelines.

The role emphasizes leadership, deep biomarker knowledge, regulatory savvy, and strong communication to enable global development and commercialization of targeted

Qualifications

• PhD in science or related field with 8+ years of experience.
• Experience in technical and regulatory aspects companion diagnostic development.
• Cross-functional experience in commercial and/or medical aspects of companion diagnostics is a plus.
• Demonstrated excellence in independently leading and conducting research and ability to evaluate, interpret and present complex scientific data.
• Experience in human translational research with biomarker application in clinical trials and awareness of challenges implementing diagnostic technologies in clinical settings.

Responsibilities

• Lead the development and implementation of diagnostic strategies for individual projects and/or therapeutic areas.
• Direct the development, outsourcing and validation of clinically applicable companion diagnostic assays for FIH and registrational studies.
• Design, implement and oversee diagnostic testing and data analysis.
• Provide expertise to development project teams to ensure access to state-of-the-art diagnostic thinking and validation status.
• Lead joint development teams between AbbVie and Dx partners to ensure fit-for-purpose CDx development and timelines.
• Serve as SME in biomarker testing technologies (IHC, FISH, NGS, PCR, flow cytometry).
• Lead interactions with global health authorities regarding CDx development and submissions.

Skills

CDx development

Biomarker testing

Immunohistochemistry

FISH

NGS

PCR

Flow cytometry

Cross-functional leadership

Scientific data analysis

English communication

Education

PhD in Science or related field

Job description

AbbVie seeks an Associate Director, Companion Diagnostics Strategy Lead to advance global diagnostic strategies supporting CDx development across oncology, immunology, and neuroscience. You will work in a highly collaborative, multidisciplinary setting and guide co-development with external partners to meet project timelines.

The role emphasizes leadership, deep biomarker knowledge, regulatory savvy, and strong communication to enable global development and commercialization of targeted