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Senior Manager, Diagnostic Portfolio Lead
2 months ago
We are seeking a highly skilled Senior Manager to lead our Diagnostics Portfolio Management team. As a key member of our organization, you will be responsible for managing and delivering a portfolio of diagnostic projects within our drug development pipeline.
Key Responsibilities- Proactively manage assigned portfolio of diagnostic projects supporting Regeneron's drug development programs
- Establish and execute partnership and operational strategies to enable delivery of diagnostic projects
- Develop, build, and implement processes and tools to support the Diagnostics function
- Effectively partner with external diagnostic manufacturers, laboratories, and vendors to support delivery of diagnostic tools and strategies
- Drive the execution of the Dx/CDx strategy in parallel to the corresponding Regeneron clinical drug development programs and studies
- Track and lead project scope, costs, budget, contracts, timelines, risks, and dependencies
- Review clinical protocols, informed consent documents, and other clinical trial deliverables
- Coordinate laboratory specifications, builds, and start-up to ensure compliant assay is ready for clinical trial patient testing
- Oversee critical samples, testing processes, and quality
- BS/MS degree and a minimum of 7+ years of multi-disciplinary experience in biotech/pharmaceutical industry, including diagnostic industry or CAP/CLIA laboratory setting
- Minimum of 3+ years in a direct project/program management role
- Experience with project management tools to provide timelines and identify milestones
- Understanding of GxP, CAP/CLIA, IVDR, and applicable ISO regulations
- Strong understanding of laboratory practices, validation procedures, and regulatory requirements
- Proficient in business technology tools and understanding data
We offer a comprehensive benefits package, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, or belief, sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
