Staff Program Manager, Clinical Sequencing CDx

Thermo Fisher Scientific • Carlsbad, CA

8d • $113,500 - $151,300 • Onsite

About The Position

Lead a portfolio of NGS-based oncology companion diagnostic programs that connect therapeutic development, clinical evidence, regulatory strategy, and patient access. As the Staff Program Manager, you will be accountable for moving programs from opportunity assessment and partner agreement through assay development, clinical and analytical validation, regulatory submission, launch, and lifecycle management. You will serve as the operating leader who creates clarity across a matrixed organization and turns complex science, partner requirements, and business commitments into reliable execution.

Requirements

• Bachelor's degree in molecular biology, genetics, biochemistry, biomedical engineering, engineering, or a related scientific or technical discipline; advanced degree is a plus.
• 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.
• Biotechnology or pharmaceutical experience is relevant when paired with meaningful exposure to diagnostics or device programs.
• 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.
• 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.
• Proficiency with program-management tools and the ability to build integrated schedules that expose dependencies, resource constraints, and the true critical path.
• 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.

Nice To Haves

• A PMP or equivalent program management certification is preferred, but demonstrated delivery of complex regulated programs is most important.
• Experience with oncology, precision medicine, NGS, molecular diagnostics, companion diagnostics, or a closely related clinical testing platform is preferred.
• Experience building budgets, financial forecasts, business cases, revenue models, or P&L inputs for development programs is preferred.

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.
• 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 protect patient impact, partner commitments, quality, and business objectives.
• 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.

Benefits

• Competitive remuneration
• Annual incentive plan bonus
• Healthcare
• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO)
• 10 paid holidays annually
• Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave)
• Accident and life insurance
• Short- and long-term disability
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

What This Job Offers

• Job Type: Full-time
• Career Level: Senior