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Skills: Program management, Oncology, Companion diagnostics, Next generation sequencing, Regulatory submission
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$114k–$151k/yr
Full-time
bachelor degree, professional certificate
Health insurance, Dental plan, Vision plan, Paid time off, Paid holidays, Paid parental leave
Posted 5d ago
~40 hrs/week
Responsibilities
The Staff Program Manager will lead the development, financial modeling, and regulatory submission of NGS-based Oncology Companion Diagnostic assays. They will serve as the primary point of contact for external clients while managing program timelines, budgets, and risk mitigation strategies.
Requirements
Candidates must possess a Bachelor's degree in Molecular Biology, Genetics, or Engineering and at least 7 years of program management experience. Proficiency in regulated medical device development under 21 CFR Part 820 and strong financial competence are required.
Full job description
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/Division-Specific Information:
Site-based. 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:
As Staff Program Manager, you will own the development, external relationships, financial model, and regulatory submission of Next Generation Sequencing (NGS) based Oncology Companion Diagnostic (CDx) assays within the Clinical Sequencing Division.As Staff Program Manager you will own the development, external relationship, financial model, and regulatory submission of Next Generation Sequencing (NGS) based Oncology Companion Diagnostic (CDx) assays within the Clinical Sequencing Division. You will complete program goals from initial concept and deal agreement through successful commercialization in coordination with external clients.
Serve as Core Team Lead and external point of contact for multiple CDx programs.
Proactively identify risks and mitigations: Develop plans to address, facilitate tradeoff decisions at the portfolio level, raise to key internal partners, remove obstacles, and seek resolution.
Develop and control program timelines in conjunction with both internal functions and external clients.
Build and control budgets with Finance and external partners.
Conduct internal and external team meetings: Ensure decisions are made with data, supervise progress, identify & implement risk mitigations, and action items are completed to support successful program execution.
Present and communicate to senior leadership routinely during Product Approval Committee (PAC) meetings and additional PMO operating mechanisms.
Ensure compliance to company Product Commercialization Process (PCP) and Quality Management Systems (QMS) for developing regulated products.
Keys to Success:
Education and Experience
BS in Molecular Biology, Genetics, or Engineering required.
Certified Project Management Professional (PMP) preferred.
7+ years of program management experience including principles, tools, and applications (i.e., timeline management, prioritization, cost estimation, risk analysis, and core team leadership).
Led multiple product development programs with an external partner to completion.
Experience with regulated medical devices developed under 21 CFR Part 820 Subpart C - Design Controls (or other regulated product development such as drugs or biologics).
Proficiency with Project Management software to lead intricate program timelines and resources.
Outstanding written and verbal presentation skills: Assertively and effectively articulates sophisticated concepts and ideas to broad audiences.
Confidence interacting with all levels of management, stays focused and on-point, and is able to raise problems or challenges in a productive manner.
Financial competence: Leads all aspects of program budgets, revenue modeling, and is comfortable reporting into Profit & Loss (P&L) statements monthly.
Outstanding influencing skills: Gets things done and drives decisions without formal authority.
Strong interpersonal skills: Nurtures relationships across the matrixed organization to resolve discord thoughtfully.
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
Program ManagementCDxNGSOncologyMolecular BiologyGeneticsEngineeringPMP21 CFR Part 820Design ControlsQMSPCPProduct CommercializationFinancial ModelingBudgetingRisk Analysis
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
For more information, please visit www.thermofisher.com.
Offices: 168 Third Avenue, Waltham, MA, US
Analytical InstrumentsLaboratory Supply Chain Programs and eCommerceLaboratory EquipmentLab ServicesSpecialty DiagnosticsLife SciencesPharma Servicesand CDMOElectronicsHealth Care
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
For more information, please visit www.thermofisher.com.
Offices: 168 Third Avenue, Waltham, MA, US
Analytical InstrumentsLaboratory Supply Chain Programs and eCommerceLaboratory EquipmentLab ServicesSpecialty DiagnosticsLife SciencesPharma Servicesand CDMOElectronicsHealth Care