Staff Program Manager, Clinical Sequencing CDx

About the role

Lead a portfolio of NGS-based oncology companion diagnostic programs that connect therapeutic development, clinical evidence, regulatory strategy, and patient access. Serve as the operating leader who creates clarity across a matrixed organization and turns complex science, partner requirements, and business commitments into reliable execution.

Responsibilities

• 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.
• Career Development: 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.
• Create a single source of truth for program health through concise dashboards, milestone reviews, risk and dependency logs, decision records, and data-driven executive updates.
• Lead launch and post-launch readiness, including operational scalability, supply and manufacturing readiness, customer and commercial enablement, performance monitoring, and lifecycle improvements.
• Anticipate risk, frame options, and drive timely decisions when priorities, data, or stakeholder perspectives conflict.
• Influence senior technical and business leaders without formal authority, manage up effectively, and create accountability across internal teams and external partners.
• Communicate complex scientific, clinical, regulatory, and financial topics with precision to both expert and executive audiences.
• Bring structure to ambiguity while remaining adaptable as biomarker strategy, clinical data, partner needs, and regulatory expectations evolve.

Requirements

• Bachelor's degree in molecular biology, genetics, biochemistry, biomedical engineering, engineering, or a related scientific or technical discipline; advanced degree is a plus.
• A PMP or equivalent program management certification is preferred, but demonstrated delivery of complex regulated programs is most important.
• Typically 7+ years leading complex programs or product development in a regulated environment, including delivery of a diagnostic, IVD, medical device, clinical-testing product, or comparable regulated product.
• Demonstrated ownership of multiple cross-functional development programs from concept through validation, regulatory submission, launch, or lifecycle update, with clear accountability for decisions, risks, dependencies, and outcomes.
• Experience with oncology, precision medicine, NGS, molecular diagnostics, companion diagnostics, or a closely related clinical testing platform is preferred.
• Demonstrated experience managing strategic biopharma, biotechnology, customer, clinical, CRO, or technology-partner relationships, including expectation-setting, commitment negotiation, escalation management, and resolution of competing priorities across internal teams, clinical sites, laboratories, consultants, and vendors.
• Working knowledge of regulated product development sufficient to plan and govern execution, including 21 CFR Part 820 design controls, ISO 13485 principles, clinical/analytical validation, risk management, traceability, and quality systems.
• Experience building budgets, financial forecasts, business cases, revenue models, or P&L inputs for development programs is preferred.
• Proficiency with program-management tools and the ability to build integrated schedules that expose dependencies, resource constraints, and the true critical path.

Qualifications

• Executive presence and outstanding written, verbal, and presentation skills.
• Strong judgment, prioritization, negotiation, and conflict-resolution skills.
• Ability to move fluidly between scientific detail, clinical evidence, regulatory requirements, operational execution, partner management, and business outcomes.
• High ownership, follow-through, and comfort being accountable for outcomes in a fast-moving, matrixed environment.

Skills

• Executive presence and outstanding written, verbal, and presentation skills.
• Strong judgment, prioritization, negotiation, and conflict-resolution skills.
• Ability to move fluidly between scientific detail, clinical evidence, regulatory requirements, operational execution, partner management, and business outcomes.
• High ownership, follow-through, and comfort being accountable for outcomes in a fast-moving, matrixed environment.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Pay

The salary range estimated for this position based in California is $113,500.00–$151,300.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

Schedule

Standard (Mon-Fri)