Program Manager III, Companion Diagnostics

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:

Carlsbad, CA. 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:

Manage defined project workstreams that contribute to NGS-based oncology companion diagnostic programs. You will coordinate work across scientific, clinical, regulatory, quality, and operational teams; maintain plans for your assigned scope; and resolve day-to-day execution issues. You will work within established program objectives and governance, bringing decisions that affect overall program direction, partner commitments, or functional priorities to the program or functional leader.

 

A Day in the Life:

• Manage the workplan for assigned workstreams, including activities, deliverables, dependencies, milestones, and acceptance criteria, within agreed objectives and scope.
• Coordinate contributors across assay and reagent development, bioinformatics and software, clinical and analytical validation, regulatory affairs, quality, manufacturing, supply chain, commercial, and customer support.
• Translate approved requirements into clear workstream tasks and track progress against the agreed plan.
• Maintain schedules, action items, risks, dependencies, and decision records for assigned work; identify potential impacts to timing, resources, or quality.
• Prepare concise status updates and materials for team reviews, highlighting progress, open issues, and decisions needed.
• Coordinate routine information exchange with external partners for assigned activities, following established communication plans and escalating changes to commitments or expectations.
• Track workstream activities related to design controls, risk management, traceability, verification and validation, change control, and regulatory submissions, in partnership with Regulatory Affairs and Quality.
• Coordinate assigned clinical or analytical validation activities against approved study plans and program milestones.
• Track budget, forecast, and resource information for assigned work and report variances to the program or functional leader.
• Coordinate assigned launch-readiness or lifecycle activities, such as readiness tracking, documentation, and follow-up on team actions.
• Identify and resolve day-to-day execution issues with relevant team members; recommend options and escalate issues that affect approved scope, program milestones, quality, or partner commitments.
• Apply program-management practices and relevant business or technical knowledge to improve the execution of assigned work.
• Adapt workstream plans to approved changes in data, requirements, or priorities and communicate impacts to affected contributors.

Keys to Success:

Education

• Bachelor’s degree in molecular biology, genetics, biochemistry, biomedical engineering, engineering, or a related scientific or technical discipline required.
• An advanced degree is a plus.
• PMP or equivalent program-management certification is preferred.

Experience

• 5+ years of related experience with a bachelor’s degree, or 3+ years with an advanced degree or equivalent work experience.
• Experience managing project workstreams or coordinating cross-functional activities in a regulated product-development environment, such as diagnostics, IVD, medical devices, clinical testing, biotechnology, or pharmaceuticals.
• Experience maintaining plans and delivering defined project activities through one or more stages of development, validation, regulatory submission, launch, or lifecycle management.
• Familiarity with oncology, precision medicine, NGS, molecular diagnostics, companion diagnostics, or a related clinical testing platform is preferred.
• Experience coordinating work with external partners, vendors, clinical teams, or CROs is preferred.
• Working knowledge of regulated product-development practices, including design controls, risk management, traceability, verification and validation, and quality systems.
• Experience using program-management tools to track schedules, dependencies, risks, and resources.

Knowledge, Skills, and Abilities

• Strong organization, follow-through, and attention to detail.
• Clear written, verbal, and presentation skills.
• Sound judgment in prioritizing work and resolving day-to-day issues.
• Ability to coordinate effectively across scientific, clinical, regulatory, quality, and operational teams.
• Ability to recognize risks and dependencies, recommend practical actions, and escalate decisions when needed.
• Ability to apply established methods and procedures while adapting plans to changing project information.

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 pay range estimated for this position Program Manager III based in California is $90,900.00–$120,000.00.

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