As a Clinical Imaging Operations Lead, you will have a leading role in the design and execution of key strategic and operational aspects of complex early and late phase clinical trials across multiple therapeutic areas, where imaging is a primary or key endpoint. You will collaborate with Clinical Imaging Science Leads and be fully integrated within clinical study teams to ensure high-quality image acquisition, data integrity, and compliance with all study specific procedures. You should expect to work closely with our imaging vendor partners, the clinical operations function, the data management function, external clinical research organizations (CROs), and clinical sites to ensure the successful completion of startup activities, ongoing execution, and close-out of clinical studies.
A day in the life may look like:
Portfolio Oversight: Responsible for the execution, functional reporting, and imaging operational oversight of specific portfolios/assets through direct study management or indirect guidance of other team members working on the portfolio. Expected to develop an in-depth knowledge aligned to the portfolio and close relationships with cross-functional colleagues in similar supporting roles.
Imaging Startup and Project Management Support: Collaborate with clinical operations study leads and cross-functional teams to manage the start-up activities of imaging components in clinical trials. Assist with imaging vendor selection, request for proposals, management, and performance tracking.
Study Documentation and Compliance: Author, review, and/or manage essential study documents such as Imaging Manuals, Independent Review Charters, Communication plans, data transmittal forms, Standard Operating Procedures, and Work Instructions. Ensure all documentation is audit-ready and filed appropriately in the Trial Master File (TMF).
Site Management and Training: Provide technical support and training to clinical site personnel, which may include conducting site initiation visits or Teleconferences. Review and approve training materials for imaging facilities and/or clinical site personnel.
Process & Technology Improvement: Participate in process and technology improvement initiatives and ensure strict compliance with all procedures and regulations.
This may be the right role for you if you have:
A well-developed knowledge of clinical imaging across multiple indications alongside an in-depth knowledge of multiple imaging vendors.
Excellent communication and organizational skills alongside strong capabilities to provide succinct and impactful updates that demonstrate a developed understanding of the impact of imaging.
People management experience is highly preferred as the role will be expected to mentor other team members effectively and may have direct reports.
In Order to be considered qualified for this role you must have: :
· BA/BS with 8+ years of clinical trial imaging experience
· Certification as a Registered Technologist (R.T.) with experience in modalities like CT, MRI, or Nuclear Medicine is highly preferred
· At least 3 years of imaging operational clinical trial experience in a pharmaceutical (sponsor) setting
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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.
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At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in. Please visit www.regeneron.com/social-media-terms for information on how to engage with us on social media. An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media.
