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As a Clinical Imaging Operations Associate Director, you will have a leading role in the designing and executing of key operational aspects of complex early and late phase clinical trials with special emphasis in oncology. Imaging includes all modalities, with a focus on CT, MRI, and PET. You will collaborate with Imaging Leads and be fully integrated within clinical teams. You should expect to work closely with several Regeneron functions including clinical operations, data management, and clinical research as well as clinical sites as you provide key oversight of external imaging clinical research organizations (CROs) to insure the successful completion of startup activities, ongoing execution, and close-out of clinical studies. You will also lead a team of highly motivated imaging operation leads.
Qualifications, skills, and all relevant experience needed for this role can be found in the full description below.
As an Associate Director, a typical day may include the following:
Designing and implementing study imaging operational components across therapeutic areas (with a focus on oncology) and imaging modalities
Collaborating with vendor relationship management and strategic sourcing & procurement in performance management of imaging CROs at the relationship level through governance
Authoring, reviewing and approving Communication Plans, Standard Operating Procedures, Work Instructions, etc.
Coordinating imaging components of study startup, including input into requests for proposal, authoring of site documents, site assessment questionnaires, and site personnel training
Collaborating closely with data management for imaging data reconciliation
Tracking imaging progress during clinical studies and addressing imaging queries that may come up in close collaboration clinical study teams, sites, and imaging CROs, including functional oversight through periodic monitoring of key performance indicators related to imaging timeliness, quality, etc., query resolution and troubleshooting
Responsibility for direct reports' oversight, development, and day-to-day management
This May Be For You If You
Excel at driving, managing, executing, and delivering results for sophisticated clinical study/program objectives
Proven history of collaborating effectively in a highly matrixed and team-based environment
Are an experienced leader within a Clinical Imaging function and want to see the impact of your work on patients
To be considered for this role we require a BA/BS with 10+ years of industry clinical imaging operations experience. Experience in GCP clinical imaging as a quantitative endpoint in clinical studies, proven organizational capabilities and experience, excellent written and verbal communication skills. Experience with CT, PET and MRI imaging acquisition with modern clinical imaging scanners. Experience in imaging CRO oversight and implementation of quality control procedures. Experience in implementation of standard response criteria in oncology (e.g. RECIST, Lugano, RANO, PCWG3, etc.) Additional experience with regulatory submissions would be a plus.
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)
$173,500.00 - $283,100.00Seniority level Seniority levelDirector
Employment type Employment typeFull-time
Job function Job functionResearch
IndustriesBiotechnology
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