Senior Manager, Companion Diagnostics Operational Management

2 days ago

Basking Ridge, New Jersey, United States Regeneron Pharmaceuticals Full time
Job Summary

We are seeking a highly skilled Senior Manager to lead our Companion Diagnostics Operational Management team. As a key member of our Diagnostic Program Management and Operational Delivery team, you will be responsible for managing and delivering a portfolio of diagnostic projects within our drug development pipeline.

Key Responsibilities
  • Manage and deliver a portfolio of diagnostic projects, working closely with Diagnostic Strategy Leads and IVD Regulatory teams.
  • Develop and implement processes and tools to support the Diagnostics function, ensuring quality, efficiency, and timely delivery.
  • Partner with external diagnostic manufacturers, laboratories, and vendors to support delivery of diagnostic tools and strategies.
  • Drive the execution of Dx/CDx strategy in parallel to Regeneron clinical drug development programs and studies.
  • Track and lead project scope, costs, budget, contracts, timelines, risks, and dependencies.
  • Coordinate laboratory specifications, builds, and start-up to ensure compliant assays are ready for clinical trial patient testing.
  • Oversee critical samples, testing processes, and quality, working with teams to resolve any related issues and escalate as needed.
Requirements
  • 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.
  • Certificate in Project Management from an accredited university.
  • 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 (e.g., Microsoft Teams, Excel, PowerPoint, etc.).
What We Offer

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 (or lack thereof), 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.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications, etc.

Salary Range (annually): $145, $237,200.00

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