Own the development, external relationship, financial model, and regulatory submission of Next Generation Sequencing (NGS) based Oncology Companion Diagnostic (CDx) assays
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
Present and communicate to senior leadership routinely during Product Approval Committee (PAC) meetings
Requirements
BS in Molecular Biology, Genetics, or Engineering
Certified Project Management Professional (PMP) preferred
7 plus years program management experience including principles, tools and applications
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
Benefits
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Next Generation SequencingOncology Companion Diagnosticprogram managementfinancial modelingregulatory submissionproduct developmentrisk identificationbudget controlproject management software21 CFR Part 820