Clinical Diagnostics Manager

Job Summary

To support end-to-end companion diagnostics strategy, the full-time Senior Manager, Clinical Diagnostics will execute diagnostic milestones, lead cross-functional teams, and manage IVD partners while working remotely.

Key responsibilities

• Execute end-to-end CDx strategy, aligning diagnostic milestones with therapeutic clinical development and regulatory timelines
• Lead cross-functional teams, integrating workstreams and providing transparent status reporting to governance bodies and senior leadership
• Manage IVD partners, negotiating scope, timelines, budgets, and quality while overseeing co-development and Joint Steering Committees

Required qualifications

• PhD in molecular biology, pathology, biomedical engineering, or equivalent
• 4+ years in diagnostics development, including 2+ years leading CDx/IVD programs in pharma or diagnostics organizations
• Proven delivery of CDx aligned to drug approvals, with successful validation and regulatory submissions
• Expertise in NGS, PCR, IHC, and immunoassays, along with validation standards and quality systems
• Strong grasp of global regulatory pathways (FDA CDRH, EU IVDR, PMDA) for CDx labeling