Staff Program Manager, Clinical Sequencing CDx

About the role

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Responsibilities

• Lead a portfolio of NGS-based oncology companion diagnostic programs that connect therapeutic development, clinical evidence, regulatory strategy, and patient access.
• Own integrated program strategy and execution for multiple companion diagnostic programs, including scope, critical path, decision points, resource needs, quality objectives, and launch readiness.
• Serve as Core Team Lead and the primary internal and external program contact for biopharma, biotechnology, CRO, clinical, and other strategic partners.
• Translate therapeutic, biomarker, clinical trial, and market requirements into executable product development plans with clear deliverables, decision rights, dependencies, and acceptance criteria.
• Establish partner governance: define operating cadence, align expectations, negotiate and manage contractual and SOW commitments, document decisions, resolve escalations, and maintain trust through transparent communication.
• Lead cross-functional planning across assay and reagent development, bioinformatics and software, clinical and analytical validation, regulatory affairs, quality, manufacturing, supply chain, commercial, medical affairs, finance, and customer support.
• Lead regulatory and quality readiness from program start through submission and approval, partnering with Regulatory Affairs and Quality on design controls, risk management, traceability, verification and validation, change control, and health-authority responses.
• Coordinate clinical validation strategy and execution for regulatory-grade studies, partnering with Clinical and Regulatory Affairs to align therapeutic requirements, evidence plans, data-generation activities, and submission milestones.
• Build and manage integrated timelines, budgets, forecasts, resource plans, and applicable financial inputs. Surface tradeoffs early and recommend decisions that