Staff Program Manager, Clinical Sequencing CDx

ThermoFisher Scientific; Carlsbad (CA); On-site; USD 114,000 - 151,000; Full time

Benefits offered by this job

Healthcare

Annual bonus

401(k) plan

Stock Purchase Plan

Job summary

Thermo Fisher Scientific in California is seeking a Staff Program Manager to lead NGS-based oncology companion diagnostics programs from opportunity assessment through launch and lifecycle management. You will serve as the operating leader, coordinating cross-functional teams, partners, and regulatory affairs to deliver high-quality, compliant programs.

Responsibilities include owning integrated program strategy, leading core teams, translating clinical and market requirements into executable

Qualifications

• 7+ years leading complex programs or product development in a regulated environment, including diagnostics or device programs.
• Ownership of multiple cross-functional development programs from concept through validation, regulatory submission, launch, or lifecycle update.
• Experience with oncology, precision medicine, NGS, molecular diagnostics, or companion diagnostics preferred.
• Experience managing strategic biopharma/biotech relationships and external partners.
• Working knowledge of regulated product development: 21 CFR Part 820, ISO 13485, validation, risk management, and quality systems.
• Experience building budgets, forecasts, or business cases for development programs (preferred).
• Proficiency with program-management tools and integrated scheduling.

Responsibilities

• Own integrated program strategy and execution for multiple companion diagnostic programs, including scope, critical path, decisions, resources, and launch readiness.
• Lead Core Team and primary contact for biopharma, biotechnology, CRO, clinical, and other partners.
• Translate therapeutic, biomarker, clinical trial, and market requirements into executable development plans with clear deliverables.
• Establish partner governance and manage contractual and SOW commitments.
• Lead cross-functional planning across assay development, bioinformatics, regulatory, quality, manufacturing, and commercial teams.
• Coordinate regulatory readiness from start through submission and approval, including design controls and risk management.
• Coordinate clinical validation strategy and execution with Clinical and Regulatory Affairs.
• Manage integrated timelines, budgets, and forecasts; surface tradeoffs and enable timely decisions.
• Create dashboards and progress updates for program health and senior leadership.
• Lead launch readiness including manufacturing, supply, and commercial enablement.

Skills

Executive presence

Communication skills

Presentation skills

Negotiation

Conflict resolution

Education

Bachelor's degree in molecular biology/related

PMP or equivalent certification (preferred)

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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.

Location/Division-Specific Information:

Canfidate who can work on-site will be given preference. Relocation assistance is NOT provided.

*Must be legally authorized to work in the United States without sponsorship.

*Must be able to pass a comprehensive background check, which includes a drug screen.

Discover Impactful Work:

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.

A day in the Life:

• 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.

Keys to Success:

Education

• 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 matters most.

Experience

• 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.

• 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.

Knowledge, Skills, and Abilities

• 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.

What Success Looks Like

• Partners and internal leaders have a clear, trusted view of program status, decisions, risks, and next milestones.

• Programs reach validation, regulatory, launch, and lifecycle milestones with predictable execution and appropriately managed tradeoffs.

• Clinical and regulatory evidence plans remain aligned to the therapeutic program and support timely patient access.

• The portfolio delivers measurable value through strong partner relationships, disciplined financial management, scalable operations, and high‑quality products.

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!

Compensation and Benefits

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. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• 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, and short- and long-term disability in accordance with company policy

• 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

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.