Director, Clinical Imaging Operations - Regeneron Pharmaceuticals : Job Details

We are seeking a director to join our Clinical Imaging team. You will have a central role in the growth and shaping of the Imaging Operations function within Clinical Imaging at Regeneron. This includes the selection, hiring, management, training and retention of direct reports responsible for the design and execution of key operational aspects of complex early and late-phase clinical trials where imaging plays a pivotal role. Imaging includes all modalities (with a focus on CT, MRI, US, DXA, digital photography, and PET). You will work closely with multiple functions and stakeholders across Regeneron, with direct reports fully integrated within clinical study teams. Responsibilities include oversight of imaging CROs to ensure the delivery of quality imaging data, generation of SOPs for harmonization of imaging processes within Regeneron, and active management of collaborators across the company at all management levels.

• Lead and develop the Clinical Imaging Operations function with supervision of multiple direct reports, remote and located at multiple sites

• Liaise and coordinate activities across collaborator functions, such as Data Management, Global Procurement (GP), Clinical Trial Management (CTM) and Vendor Relationship Management (VRM)

• Liaise with imaging scientific leads to ensure operational feasibility and execution of imaging strategies

• Collaborate with VRM and GP in imaging vendor oversight and performance management

• Design and implement imaging operational procedures across all therapeutic areas and imaging modalities

• Author, review and approve Imaging Manuals, Communication Plans, study document templates and SOPs

• Support regulatory interactions and inspection activities related to clinical imaging

• Coordinate, review, serve as escalation point and troubleshoot imaging procedures related to study startup, including input into requests for proposal, authoring of site documents, query tracking and resolution, and site personnel training

• Track imaging progress across multiple clinical studies and address imaging issues that may come up in close collaboration with the clinical study team, sites, and imaging CROs, including functional oversight through day-to-day monitoring of key performance indicators related to imaging timeliness, quality, etc.

• Lead internal and external collaborative activities related to the development of new technologies and innovative approaches to increase the operational efficiency of clinical imaging

• Lead process improvement initiatives to create efficiencies in the implementation of operations aspects of imaging throughout the lifecycle of studies

• Extensive experience managing direct reports as well as excellent relationship management skills

• You possess outstanding written and verbal communication skills

• Proven organizational capabilities and experience, ability to work in fast-paced and dynamic environment

To be considered for this role, you must have a BA/BS or PhD (engineering/biology/imaging fields preferred) with 10+ years of clinical imaging experience as applied to drug development is required. We are seeking knowledge of CT, PET, US and MRI imaging acquisition & analysis techniques, Qualified candidates will have experience in GCP clinical imaging as a quantitative endpoint in clinical studies and experience in clinical imaging operations. Experience in regulatory interactions and submissions. We need familiarity with modern clinical imaging scanners.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) 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. 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.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

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)