The Manager, Clinical Supply Systems, is a key member of the Clinical Supply Systems Group whose primary responsibility is supporting the governance and standards established at Regeneron for all clinical studies utilizing an Interactive Response Technology (IRT) system. These systems are also routinely referenced as IVRS, IWRS, RTSM, etc. This group resides within the Clinical Drug Supply and Logistics Department.

The role collaborates with several functional areas such as clinical trial management, data management, biostatistics, and clinical supply leads, regarding system requirements/specifications, oversight during study conduct, and closeout activities.

A typical day in this role looks like:

• Leads and/or maintains sponsor standardizations with 3rd party IRT vendors
• Guides and supports internal team through inspection preparations
• Establishes and maintains operational governance of 3rd party IRT vendor
• Responsible for mentoring and training new personnel as needed
• Leads and/or supports in continuous improvement initiatives
• Works directly with study teams to gather requirements and ensure IRT systems are developed in line with study protocol
• Develops and manages system deployment timelines for IRT
• Manages IRT documentation which include but is not limited to requirements, user guides, training materials, and communication plans
• Manages the deployment of IRT applications with internal teams and contract vendor
• Provides guidance related to contracted vendors’ functionality, performance, and processes
• Works with Clinical Logistics and Biostats on the upload of key information (i.e., subject randomization and kit lists, etc.)
• Oversees routine meetings with contract vendor regarding performance, issues identification/resolution, and risk management
• Ensure effective training plans for IRT systems are developed for clinical teams and site personnel with the contract vendor

This role may be for you if:

• Experience developing IRT systems for clinical trials.
• Through understanding clinical trial protocol and translated for system development.
• Knowledge of ICH/GCP and regulatory guidelines/directives; Disease/therapeutic area knowledge (a plus).
• Leadership and negotiation skills; Mentoring/coaching skills.
• Ability to effectively multi-task and prioritize.
• Effective problem-solving skills.
• Written and verbal communication and presentation skills in small and large group settings.
• Project management and organizational skills.
• Cross functional and cross-cultural awareness.

In order to be considered qualified for this role a minimum of a Bachelor’s degree and at least 5 years of relevant experience in the biotechnology/pharmaceutical industry, with minimum 3 years working in an IRT environment is required.

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.