Director, Global Diagnostic Strategy Lead (DxSL)
Core
Lead the creation, alignment, and execution of comprehensive global diagnostic strategies for assigned molecules and programs within a disease area to enable clinical development, regulatory approval, and commercialization.
Role type
Director, Global Diagnostic Strategy Lead
Builds
Integrated diagnostic and therapeutic development plans, regulatory evidence packages, and operational testing strategies for precision therapeutics.
Domain
Biotechnology / Oncology / Inflammation / General Medicine / Rare Disease
Required skills
Diagnostic strategy development, biomarker biology assessment, assay and platform selection, regulatory strategy, cross-functional matrix leadership, stakeholder engagement, team management, risk analysis, commercial pathway evaluation
Preferred skills
Experience with next-generation sequencing, PCR, immunohistochemistry, immunoassays, digital pathology
Technologies
Next-generation sequencing, PCR, immunohistochemistry, immunoassays, digital pathology
Responsibilities
Develop end-to-end diagnostic strategies from need assessment through lifecycle management; Partner with product teams to align therapeutic and diagnostic objectives; Evaluate and propose strategic options including assay approaches and partner strategies; Lead Dx Development Teams to ensure tactical execution; Represent the Dx function with internal and external stakeholders; Manage and coach a team of Dx technical leads
Seniority
Director, strategic leadership with hands-on execution