Director, Diagnostics: Rare-Disease CDx Strategy

Alexion; Boston (MA); Hybrid; USD 181,000 - 271,000; Full time

Job summary

AstraZeneca is seeking a Director, Diagnostics to lead the Diagnostics Center of Excellence for rare diseases. You will shape end-to-end diagnostic approaches from late discovery through lifecycle management, coordinating translational science, IVD development, and global regulation to accelerate enrollment and regulatory readiness.

You will own trial-level diagnostic strategies, drive CDx development with partners, and build capabilities and partnerships that shorten the diagnostic odyssey

Qualifications

• Advanced degree in a relevant scientific field with 10+ years in precision medicine/diagnostics.
• Proven track record leading diagnostic strategy and CDx development with regulatory approvals.
• Experience with global regulatory pathways (FDA IDE/PMA; EU IVDR CPS) and design control.

Responsibilities

• Strategy and Portfolio Leadership: define disease-specific diagnostic strategies and prioritize portfolio impact.
• Clinical Trial Diagnostics and CDx: own trial-level diagnostic strategies and CDx development timelines.
• Regulatory Excellence: partner for global submissions and ensure design controls compliance.
• Translational Integration: translate hypotheses into robust biomarkers and endpoints.
• Technology and IVD SME: guide assay selection and commercialization readiness.
• External Partnerships: manage diagnostic partners, budgets, and milestones.
• Operating Model and Governance: establish processes and dashboards for initiatives.
• Budget and Resource Management: optimize budgets and timelines across programs.
• Horizon Scanning: monitor emerging tests and regulatory changes to stay competitive.

Skills

Diagnostics leadership

CDx development

Regulatory strategy

Cross-functional leadership

Biomarker validation

Program management

Vendor management

Delivery mindset

Office-based with flexibility

Education

PhD or equivalent in relevant field

Job description

AstraZeneca is seeking a Director, Diagnostics to lead the Diagnostics Center of Excellence for rare diseases. You will shape end-to-end diagnostic approaches from late discovery through lifecycle management, coordinating translational science, IVD development, and global regulation to accelerate enrollment and regulatory readiness.

You will own trial-level diagnostic strategies, drive CDx development with partners, and build capabilities and partnerships that shorten the diagnostic odyssey