Senior Director Diagnostic Assays/Cancer Biomarker Development job opportunity at AstraZeneca.

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AstraZeneca Senior Director Diagnostic Assays/Cancer Biomarker Development
Experience: 5-years
Pattern: full-time
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loacation US - Gaithersburg - MD, United States Of America
loacation US - Gaithersb..........United States Of America

Job Title: Senior Director Diagnostic Assays/Cancer Biomarker Development Location: Gaithersburg  / Boston Hybrid Working Model: 3 days per week from office   Introduction to role: Are you ready to lead cancer biomarker strategy that gets the right therapy to the right patient sooner and proves efficacy earlier? Do you want to shape how circulating tumor DNA and other cutting-edge assays drive decisive clinical action across a fast-moving oncology pipeline? As Senior Director for Diagnostic Assays/Cancer Biomarker Development, you will set the vision and lead the delivery of assays that enable earlier patient identification, smarter trial designs, and faster, clearer readouts that guide development decisions. Working from our global hubs in Gaithersburg or Boston, MA, you will partner across clinical development, translational science, biostatistics, and regulatory teams to turn scientific insight into reliable, scalable diagnostic solutions that improve outcomes for people living with cancer. Accountabilities: - 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. Essential Skills/Experience: - PhD or equivalent, MD or equivalent preferred - 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 Desirable Skills/Experience: - 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 When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. Why AstraZeneca: Here, bold science meets practical delivery. You will join a rapidly growing oncology community that fuses cutting-edge biology with advanced technology, backed by strong investment and a pipeline spanning multiple indications. We unite unexpected teams to push boundaries, partnering with world-leading centers to accelerate progress in some of the hardest-to-treat cancers. We value kindness alongside ambition, giving you the trust, tools, and collaborators to turn biomarker insight into real impact for millions of patients while shaping the next wave of oncology breakthroughs. In the US, the annual base salary for this position ranges from $ 182,645.60 - 273,968   USD. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.    Step into this pivotal role and lead the assays that will redefine cancer care—bring your vision to our team and apply today! Date Posted 27-Jan-2026 Closing Date 02-Feb-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In 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.

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