Director, Precision Diagnostics - Oncology

About the role

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Responsibilities

• Execution of precision diagnostics strategy for oncology programs, spanning multiple assets and therapeutic areas.
• Define diagnostic requirements for trials and, in partnership with clinical teams, implement biomarker selection, assay validation, and biological sample collection/handling strategy.
• Oversee project plans, budgets, and timelines to ensure on-time, high-quality delivery of diagnostic milestones via cross-functional collaboration with project management, biomarkers, clinical & biomarker operations, external engagement, procurement, etc.
• Work with regulatory and quality teams to ensure diagnostic development meets regulatory expectations and requirements and in diagnostic regulatory submissions.
• Engage external partners, including diagnostic companies, clinical labs and technology vendors, to accelerate assay development and access to patient samples.
• Provide frequent project status updates and reports related to diagnostic deliverables in collaboration with project management, finance and business operations/Share learnings and best practices for diagnostic development and execution and participate in initiatives for key organizational process improvements.

Qualifications

• Bachelor's degree in life sciences, molecular diagnostics, clinical laboratory science, or related field.
• 6+ years of experience in diagnostic development, biomarker strategy, and/or clinical assay development, with 2+ years direct experience in oncology diagnostic development.
• Experience integrating diagnostics into clinical trial design and familiarity with clinical trial design elements such as efficacy endpoints, biomarker testing, data management and human biological specimen management and operations.
• Experience in regulatory requirements for diagnostics or companion diagnostics and quality management systems, including FDA and EU medical device regulations and QSR regulations, GMP manufacturing, ISO13485, etc.
• Diagnostic protocol and analysis plan development required to support diagnostic development and regulatory submissions.
• Management of cross-functional projects, timelines, and budgets in a matrix environment.
• Stakeholder management, including working with clinical teams, external partners and clinical laboratories.