Staff Program Manager, CDx
About The Position
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. This is a site-based position and relocation assistance is NOT provided. Candidates must be legally authorized to work in the United States without sponsorship and able to pass a comprehensive background check, which includes a drug screen. 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. 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.
Requirements
- BS in Molecular Biology, Genetics, or Engineering required.
- 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.
Nice To Haves
- Certified Project Management Professional (PMP) preferred.
Responsibilities
- 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.
- 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.
Benefits
- Competitive remuneration
- Annual incentive plan bonus
- Healthcare
- 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
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
