Director Diagnostics
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Job Location:
Boston, NH - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Are you ready to lead the charge in redefining diagnostic strategies As the Director of Diagnostics youll spearhead the Diagnostics Center of Excellence (DxCoE) strategy driving innovation from late discovery through clinical development registration launch and lifecycle management. Your mission is to craft end-to-end diagnostic approaches that accelerate precision medicine at scale. Youll lead the clinical trial diagnostic strategy ensuring swift patient enrollment high-quality data and regulatory readiness. Join us in building capabilities processes and partnerships that shorten the diagnostic odyssey and redefine patient care.
Accountabilities
Strategy and Portfolio Leadership: Define disease-specific diagnostic strategies based on a understanding of patient journeys clinical practice and healthcare systems. Prioritize portfolio impact and resource allocation to improve outcomes.
Clinical Trial Diagnostics and CDx: Lead trial-level diagnostic strategies including assays algorithms inclusion criteria CDx definition and development. Drive timelines to meet enrollment and submission timelines for co-approval of drug and CDx.
Regulatory Excellence: Collaborate with internal device/diagnostic regulatory teams and external partners to deliver global submissions and maintain compliance under design control.
Translational Integration: Work with Translational Science & Medicine to translate disease hypotheses into biomarkers and clinical endpoints. Ensure robust analytical and clinical validation plans.
Technology and IVD SME: Serve as a subject matter expert for IVD technologies guiding assay selection analytical performance clinical utility and commercialization readiness.
External Partnerships: Identify and lead partners negotiate scope budgets and deliverables. Lead all aspects of execution with success metrics and risk mitigation.
Operating Model and Governance: Establish processes standards and dashboards for diagnostic initiatives. Ensure timely communication and alignment with program teams and senior leadership.
Budget and Resource Management: Secure budgets optimize vendor and internal resourcing maintain clarity on timelines risks and outcomes.
Horizon Scanning: Stay informed on emerging tests platforms and guideline updates. Evolve strategies to reflect scientific clinical and regulatory changes.
Essential Skills/Experience
- Advanced degree (PhD or equivalent) in a relevant scientific field; 10 years in precision medicine/diagnostics within pharma/biotech spanning discovery to launch.
- Consistent 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 cases.
- Outstanding cross-functional leadership communication and collaborator 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 bold timelines.
- Experience leading external vendors/alliances and complex budgets; well-adapted in risk management and governance.
At AstraZenecas Alexion division youll find a unique blend of entrepreneurial spirit within a leading biotech supported by the resources of a global pharma. Our commitment to patients living with rare diseases drives us to innovate continuously. Here youll be part of an energizing culture where connections are built to explore new ideas. With tailored development programs designed for skill enhancement and fostering empathy for patient journeys youll be empowered to make a real impact. Join us in a community that celebrates diversity innovation and the power of connection.
Ready to redefine diagnostics for rare diseases Apply now to join our team!
Date Posted
05-Nov-2025Closing Date
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.
Required Experience:
Director
Key Skills
- Fundraising
- Management Experience
- Coaching
- Analysis Skills
- Strategic Planning
- Team Management
- Budgeting
- Leadership Experience
- Mentoring
- Public Speaking
- negotiation
- Supervising Experience
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more
