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.

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 at least 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.

Director – Precision Diagnostics, Oncology

Key skills