Alexion Pharmaceuticals, Inc. · 17 hours ago
Senior Director Diagnostic Assays/Cancer Biomarker Development
Gaithersburg, Maryland, United States of America
Full-time
Hybrid
Lead/Staff, Director/Executive
$183K/yr - $274K/yr
5+ years expAlexion Pharmaceuticals, Inc. is seeking a Senior Director for Diagnostic Assays/Cancer Biomarker Development to lead cancer biomarker strategy aimed at improving patient outcomes. The role involves setting the vision for assay development, collaborating across teams, and ensuring regulatory compliance while driving innovation in cancer diagnostics.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Biomarker Strategy Leadership: Define and execute strategies that use biomarkers to match patients to the right treatment and assess efficacy as early as possible, with an initial emphasis on circulating tumor DNA
CtDNA Innovation: Guide assay selection, validation, and deployment for minimal residual disease, response monitoring, and earlier patient identification, ensuring clinical utility and scalability
Clinical Trial Enablement: Design and implement biomarker-driven trial approaches that accelerate decision-making and strengthen evidence for new therapies
Data and Technology Influence: Provide expert advice to shape technology platforms and data analytics internally and with partners, anticipating future clinical development needs
Integrated Evidence Building: Combine data on new compounds and targeted disease biology to create assay strategies that de-risk programs and sharpen portfolio decisions
External Collaboration: Liaise with medical and technology leaders across academia, diagnostics, and industry to track advances and translate them into our trials
Governance and Subject Matter Expertise: Serve as the subject matter expert and governance reviewer for strategic initiatives and specific proposals
Regulatory Leadership: Lead regulatory communication and prepare high-level documents that support biomarker and assay use in clinical development
Process and Technology Modernization: Manage or support complex and groundbreaking projects to improve processes within translational science and introduce new technologies and approaches at national, regional, or global scale
Compliance Stewardship: Ensure your work and the function’s activities align with Good Laboratory Practice, Safety Health and Environment standards, and all relevant internal and external regulations
Qualification
Required
PhD or equivalent
Experience of the development and application of circulating tumor DNA assays for clinical use
5+ years of experience in aligned to the drug development or process in industry or academia or equivalent
Extensive experience of crafting and implementing clinical trials using novel biomarker approaches for the earlier identification of patients
Well-developed understanding of biomarker analysis
Experience of communicating complex science to a clinical audience including external professional and regulatory bodies
Proven experience managing and designing clinical trials
Preferred
MD or equivalent preferred
Leadership of cross-functional, global teams delivering biomarker strategies from concept to clinical deployment
Experience shaping and submitting regulatory documentation for diagnostics, companion diagnostics, and IVDs
Expertise in bioinformatics and analytical pipelines for ctDNA, including variant calling and minimal residual disease monitoring
Familiarity with assay validation and operational frameworks such as CAP, CLIA, and IVDR
Track record of high-impact publications, patents, or conference presentations in oncology biomarkers and clinical diagnostics
Experience building external partnerships with diagnostic companies, contract research organizations, and leading academic centers
Proven ability to drive assay adoption across multi-center clinical trials with robust sample logistics and data integrity
Portfolio, budget, and vendor management experience for translational biomarker programs
Benefits
Short-term incentive bonus opportunity
Equity-based long-term incentive program
Qualified retirement program [401(k) plan]
Paid vacation and holidays
Paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage
Company
Alexion Pharmaceuticals, Inc.
Alexion, AstraZeneca Rare Disease is focused on pioneering new possibilities for the rare disease community.
1001-5000 employees
H1B Sponsorship
Alexion Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (49)
2024 (57)
2023 (51)
2022 (29)
2021 (27)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$5.8M2020-12-12Acquired
1999-02-12Post Ipo Equity· $5.8M
1996-02-29IPO
Leadership Team
Frederic Chereau
SVP, Strategy and Business Development
Imran Shakur
Director, IRT and Technology Lead
Recent News
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2025-12-20
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