Staff Program Manager, Clinical Sequencing CDx
Core
Lead a portfolio of NGS-based oncology companion diagnostic programs, managing execution from opportunity assessment through regulatory submission, launch, and lifecycle management.
Role type
Staff Program Manager (Clinical Sequencing CDx)
Builds
NGS-based oncology companion diagnostic programs
Domain
Life Sciences / Oncology / Molecular Diagnostics
Deliverable
product features
Required skills
Program strategy and execution, Cross-functional leadership, Partner governance and negotiation, Regulatory and quality readiness, Clinical validation strategy, Integrated timeline and budget management, Risk management, Stakeholder influence
Preferred skills
PMP certification, Oncology or precision medicine experience, NGS or molecular diagnostics experience, Biopharma partner relationship management, Financial forecasting
Technologies
Program-management tools
Responsibilities
Own integrated program strategy and execution for multiple companion diagnostic programs, Serve as Core Team Lead and primary contact for strategic partners, Translate therapeutic and market requirements into executable product development plans, Establish partner governance and manage contractual commitments, Lead cross-functional planning across assay, bioinformatics, clinical, regulatory, and commercial teams, Lead regulatory and quality readiness from program start through approval, Coordinate clinical validation strategy and execution for regulatory-grade studies, Build and manage integrated timelines, budgets, and resource plans, Create dashboards and data-driven updates for program health, Lead launch and post-launch readiness including operational scalability
Seniority
Senior, hands-on IC
