Director, Diagnostics & CDx Strategy — Rare Disease

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

Job summary

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

You will own trial‑level diagnostic strategies, drive CDx co‑development with partners, and build capabilities and partnerships to shorten diagnostic odysseys and enable precision medicine at scale.

Qualifications

• Advanced degree (PhD or equivalent) in a relevant scientific field and 10+ years in precision medicine/diagnostics across discovery to launch.
• Proven track record leading diagnostic strategy and execution for clinical programs, including CDx development and PMA approval in partnership with diagnostic companies.
• Hands‑on experience with global regulatory pathways (FDA IDE/PMA; EU IVDR CPS/performance requirements), design control, and quality system expectations.
• Deep expertise in biomarker validation (analytical/clinical) and IVD development across modalities (genomics, proteomics, metabolomics; immunoassays, NGS).
• Strong portfolio thinking to translate disease biology into actionable diagnostic strategies and business cases.
• Exceptional cross‑functional leadership and stakeholder management across discovery, clinical development, regulatory, and commercial teams.
• Proven ability to build new capabilities, processes, and partnerships; comfortable operating in ambiguity and delivering tight timelines.
• Experience managing external vendors/alliances and complex budgets with disciplined risk management.
• Self‑starter with a delivery mindset; able to set direction and roll up sleeves when needed.

Responsibilities

• Define disease‑specific diagnostic strategies grounded in patient journey and healthcare systems; prioritize portfolio impact and resource allocation.
• Own trial‑level diagnostic strategies (assays, algorithms, inclusion criteria) and lead CDx development with partners to meet enrollment milestones.
• Partner with regulatory experts to deliver timely global submissions and sustain design‑control compliance.
• Translate targets into fit‑for‑purpose biomarkers and endpoints; ensure validation plans support labeling and clinical utility claims.
• Guide assay selection, analytical performance, and commercialization readiness for scale.
• Identify, select, and manage diagnostic partners; set budgets, deliverables, and success metrics.
• Establish governance processes and dashboards for diagnostic initiatives; align with senior leadership for fast decisions.
• Secure budgets and optimize internal and vendor resources; monitor timelines and risks to maximize ROI.
• Maintain horizon scanning to adapt strategies to scientific and regulatory shifts.

Skills

Diagnostics strategy

CDx development

Regulatory know‑how

Biomarker validation

Cross‑functional leadership

Vendor management

Education

PhD or equivalent

Job description

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

You will own trial‑level diagnostic strategies, drive CDx co‑development with partners, and build capabilities and partnerships to shorten diagnostic odysseys and enable precision medicine at scale.