Director, Diagnostics — Rare Disease CDx Strategy

AstraZeneca; 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 strategy across our rare disease portfolio, shaping end-to-end diagnostic approaches from late discovery through lifecycle management.

You will own clinical trial diagnostic strategy, drive co-development of companion diagnostics, and partner with external organizations to accelerate enrollment and regulatory readiness, impacting patient access and program value.

Qualifications

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

Responsibilities

• Strategy and Portfolio Leadership: define disease-specific diagnostic strategies and prioritize portfolio impact.
• Clinical Trial Diagnostics and CDx: drive CDx development and trial inclusion criteria to meet milestones.
• Regulatory Excellence: lead global submissions and maintain design control compliance.
• Translational Integration: align biomarkers/endpoints with strategy and validation plans.
• Technology and IVD SME: guide assay selection and commercialization readiness.
• External Partnerships: manage diagnostic partners, budgets, deliverables, and milestones.
• Operating Model and Governance: establish processes and dashboards for initiative governance.
• Budget and Resource Management: optimize resources and timelines across programs.
• Horizon Scanning: monitor emerging tests and guideline changes to maintain competitive edge.

Skills

Cross-functional leadership

Regulatory knowledge

Biomarker validation

Strategic portfolio leadership

External partnerships

Ambiguity management

Education

PhD or equivalent in a relevant field

10+ years in precision medicine/diagnostics

Job description

AstraZeneca is seeking a Director, Diagnostics to lead the Diagnostics Center of Excellence strategy across our rare disease portfolio, shaping end-to-end diagnostic approaches from late discovery through lifecycle management.

You will own clinical trial diagnostic strategy, drive co-development of companion diagnostics, and partner with external organizations to accelerate enrollment and regulatory readiness, impacting patient access and program value.