Staff Program Manager, NGS - CDx

Work Schedule

Environmental Conditions

Job Description

Do you have a passion for innovative ideas and groundbreaking discoveries? With over $1 billion invested annually in R&D, at Thermo Fisher Scientific you’ll help solve some of the world’s toughest challenges, from giving cancer patients hope, ensuring safe drinking water and helping law enforcement tackle cases through forensics. We empower our teams to put science into meaningful action and give our R&D colleagues the autonomy, resources and tools they need to take science a step beyond.

Remote

Or if local, on-site: Carlsbad, CA; Austin, TX

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.

• BS in Molecular Biology, Genetics, or Engineering
• Certified Project Management Professional (PMP) preferred

• 7 plus years program management experience including principles, tools and applications. (i.e., timeline management, prioritization, cost estimation, risks 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 able to raise problems or challenges in productive manner.
• Financial competence: Leads all aspects of program budgets, revenue modeling, and 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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. A one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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: https://jobs.thermofisher.com/global/en/total-rewards