Director, Precision Diagnostics Oncology
Core
Implement diagnostic development encompassing technical, development, regulatory, commercial, and business development efforts for oncology programs.
Role type
Director, Precision Diagnostics Oncology
Builds
Diagnostic strategies and solutions aligning with oncology development needs
Domain
Biopharma, Oncology, Precision Diagnostics
Required skills
Diagnostic development, Clinical trial design, Regulatory submissions (FDA, EU IVDR), Cross-functional project management, Biomarker selection, Assay validation, Budget and timeline management, External partner engagement
Preferred skills
NGS/PCR/immunohistochemistry assay development, Regulatory interactions for diagnostic devices, Laboratory accreditation standards (ISO 13485), GMP manufacturing, Commercial launch partnership
Technologies
NGS, PCR, Immunohistochemistry
Responsibilities
Execute precision diagnostics strategy for oncology programs; Define diagnostic requirements for trials and implement biomarker selection/assay validation; Oversee project plans, budgets, and timelines; Work with regulatory teams to ensure compliance; Engage external partners to accelerate assay development; Provide project status updates and reports
Seniority
Director, strategic leadership & cross-functional execution