Senior Manager, Diagnostics (IVD) Operations Lead

Job Description

The Senior Manager, Diagnostics (IVD) Operations Lead is responsible for the build, implementation and maintenance of centralized processes and infrastructure to enable diagnostic (IVDs) strategy, development and use within Regeneron clinical trials, including adherence to global country specific requirements and delivery of Companion Diagnostics (CDx). This role will work closely with Precision Medicine colleagues and Regulatory Affairs within Regeneron and external diagnostic partners (including laboratories) to ensure adherence to global IVD regulations and quality requirements (e.g. IVDR, VALID Act, ISO standards, etc.) and support clinical study teams on clinical trial readiness and execution.

As a Senior Manager in Precision Medicine, a typical day may include the following:

• Design, build, implement and maintain processes and tools to support and manage the use of IVDs within Regeneron clinical trials according to global quality, regulatory and clinical requirements (e.g. IVDR)
• Launch and lead initiative to design and deliver internal processes specific to Companion Diagnostics delivery and management and maintain ongoing process ownership
• Build IVD and CDx knowledge center and increase awareness and expertise amongst internal stakeholders

• Manage a large, cross-functional team of internal and external experts to assess and reach decisions on IVD utility and compliance within Regeneron clinical trials
• Work with functions across Regeneron to ensure awareness and education on global IVD landscape and requirements (e.g. training, change management, etc.)
• Assess and partner with vendors to provide supplemental resourcing as needed for complex IVD scenarios and global implementation
• Collaborate closely with IVD Laboratory & Assay Lead to review laboratory and assay solutions and track and maintain lessons learned, knowledge center for related IVD global adherence
• Support and/or lead diagnostic delivery on specific clinical programs/studies as needed

This role may be for you if:

• You possess strong communication and presentation skills
• Ability to work cross-functionally in a matrixed environment

To be considered for this role, you must have a BS or MS with a minimum 5-7 years experience in clinical trials, diagnostic/drug development, and/or laboratory quality or regulatory. We are seeking experience working with cross-functional clinical trial study teams and expertise in IVD (+CDx) application in the clinical trial setting. Laboratory quality, regulatory & compliance experience a plus. We need an individual with extensive process development, project management experience including budget management, vendor engagement. Proficient in business technology tools and understanding data (e.g. Microsoft Teams, Excel, PowerPoint, etc.).

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$141,800.00 - $231,400.00