Program Manager III, Companion Diagnostics
Core
Manage defined project workstreams for NGS-based oncology companion diagnostic programs, coordinating cross-functional teams to deliver regulated products.
Role type
Senior IC program manager (regulated product development)
Builds
NGS-based oncology companion diagnostic programs
Domain
Oncology / Molecular Diagnostics / Regulated Product Development
Required skills
Program management, cross-functional coordination, regulated product development lifecycle management, risk management, schedule and resource tracking, external partner coordination, budget forecasting
Preferred skills
Oncology or precision medicine domain knowledge, NGS or companion diagnostics experience, CRO/vendor management, PMP certification
Technologies
Program management tools
Responsibilities
Manage workplans including activities, deliverables, dependencies, milestones, and acceptance criteria; Coordinate contributors across assay development, bioinformatics, clinical validation, regulatory affairs, quality, manufacturing, and commercial teams; Track workstream activities related to design controls, risk management, traceability, verification, validation, and regulatory submissions; Coordinate clinical or analytical validation activities against approved study plans; Track budget, forecast, and resource information; Coordinate launch-readiness or lifecycle activities; Identify and resolve day-to-day execution issues; Adapt workstream plans to approved changes in data, requirements, or priorities.