Staff Program Manager, Clinical Sequencing CDx

Work Schedule

Environmental Conditions

Job Description

When youre part of the team at Thermo Fisher Scientific youll do important work. And youll 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-SpecificInformation:

Carlsbad CA or Austin TX. Relocation assistance is NOT provided.

*Must be legally authorized to work in the United States withoutsponsorship.

*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.

• 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.

• Bachelors 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. 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.

• 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.

• 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

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: Experience:

Staff IC