Senior Manager, Companion Diagnostics Operational Management

1 day ago

Armonk, New York, United States Regeneron Pharmaceuticals Full time
Job Title: Senior Manager, Companion Diagnostics Operational Management

The role of Senior Manager, Diagnostics Program Management & Operational Delivery, is expected to manage and deliver a portfolio of diagnostic projects (CDx, IVD, etc.) within Regeneron's drug development pipeline in close partnership with Diagnostic Strategy Leads and IVD Regulatory. This role includes portfolio management, program/project management and operational execution of complex diagnostic strategies to support clinical programs across a variety of therapeutic indications.

Key Responsibilities:
  • Proactively manage assigned portfolio of diagnostic projects supporting Regeneron's drug development programs
  • Working with the diagnostic team and key internal functions, establish and execute partnership and operational strategies to enable delivery of diagnostic projects
  • Develop, build and implement processes and tools to support and the Diagnostics function to ensure quality, efficient and timely delivery
  • Effectively partner with external diagnostic manufacturers, laboratories and vendors to support delivery of diagnostic tools and strategies. Provide oversight and leadership of external relationships as needed
Requirements:
  • BS/MS 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.)
About Regeneron Pharmaceuticals:

Regeneron Pharmaceuticals 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.

The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

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): $145,400.00 - $237,200.00

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