Director, Diagnostics: Rare Disease CDx Strategy & Global

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

Job summary

AstraZeneca seeks a Director, Diagnostics in the US to lead the Diagnostics Center of Excellence strategy across the rare disease portfolio, shaping end-to-end diagnostic approaches from late discovery through registration and lifecycle management.

You will own the clinical trial diagnostic strategy, drive companion diagnostic co-development, and build capabilities and partnerships to shorten the diagnostic odyssey and enable precision medicine at scale.

Qualifications

• Advanced degree (PhD or equivalent) in a relevant scientific field; 10+ years in precision medicine/diagnostics within pharma/biotech, spanning 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; familiarity across modalities and methodologies (genomics, proteomics, metabolomics; immunoassays, biochemical assays, NGS, etc.).
• Strong portfolio thinking with the ability to translate disease biology and patient journey insights into actionable diagnostic strategies and business cases.
• Exceptional cross-functional leadership, communication, and stakeholder management across discovery, clinical development, regulatory, commercial, and medical affairs.
• Demonstrated success building new capabilities, processes, and partnerships; comfortable leading in ambiguity and delivering against aggressive timelines.
• Experience managing external vendors/alliances and complex budgets; disciplined in risk management and governance.
• Self-starter with a delivery mindset; able to both set direction and roll up sleeves as needed.
• Ability to work in an office-based environment and perform essential functions with or without accommodation.

Responsibilities

• Strategy and Portfolio Leadership: Define disease-specific diagnostic strategies grounded in deep understanding of the patient journey, clinical practice, and healthcare systems; prioritize for portfolio impact and resource allocation to deliver near-term trial readiness while setting the long-term platform for precision medicine growth.
• Clinical Trial Diagnostics and CDx: Own trial-level diagnostic strategies (assays, algorithms, inclusion criteria), define and lead CDx development with diagnostic partners, and drive timelines to meet enrollment and co-submission milestones that enable first-in-class and best-in-class approvals.
• Regulatory Excellence: Partner with device/diagnostic regulatory experts and external collaborators to deliver timely, high-quality global submissions (FDA IDE, PMA; EU IVDR CPS and performance dossiers; other regional requirements) and sustain compliance under design control to de-risk launches.
• Translational Integration: Translate target and mechanism hypotheses into fit-for-purpose biomarkers and endpoints in partnership with Translational Science & Medicine; ensure analytical and clinical validation plans are robust to support decision-making, labeling, and clinical utility claims.
• Technology and IVD SME: Serve as the subject matter expert for IVD technologies and development pathways; guide assay selection, analytical performance, clinical utility, and commercialization readiness to scale access and adoption.
• External Partnerships: Identify, select, and manage diagnostic partners; negotiate scope, budgets, and deliverables; set success metrics and mitigation plans that keep programs on track and value-focused.
• Operating Model and Governance: Establish processes, standards, and dashboards for diagnostic initiatives; ensure transparent communication and alignment with program teams, governance bodies, and senior leadership for fast, quality decisions.
• Budget and Resource Management: Secure budgets, optimize internal and vendor resourcing, and maintain visibility of timelines, risks, and outcomes to maximize return on investment across the portfolio.
• Horizon Scanning: Maintain an up-to-date view of emerging tests, platforms, and clinical guideline changes; evolve strategies to reflect scientific, clinical, and regulatory shifts, ensuring sustained competitive advantage.

Skills

Precision medicine

CDx development

Biomarker validation

Regulatory strategy

Global regulatory experience

IVD development

Cross-functional leadership

Program management

Vendors/alliances management

Strategic portfolio leadership

Delivery mindset

Education

PhD in a relevant field

Job description

AstraZeneca seeks a Director, Diagnostics in the US to lead the Diagnostics Center of Excellence strategy across the rare disease portfolio, shaping end-to-end diagnostic approaches from late discovery through registration and lifecycle management.

You will own the clinical trial diagnostic strategy, drive companion diagnostic co-development, and build capabilities and partnerships to shorten the diagnostic odyssey and enable precision medicine at scale.