Manager Clinical Supply Systems

Regeneron Pharmaceuticals, Inc (USA); Armonk (NY); Hybride; USD 115 000 - 187 000; Plein temps

Résumé du poste

Regeneron Pharmaceuticals, Inc (USA) is seeking a Clinical Supply Systems Manager to support the Clinical Supply Systems Group in a hybrid arrangement across multiple locations in the United States. The role focuses on IRT systems, vendor oversight, and cross-functional collaboration with trial management, data management, biostatistics and clinical supply leads.

The position requires a Bachelor's degree or eight years’ equivalent experience, with at least four years in biotech/pharma and two

Qualifications

• Bachelor's degree or eight years’ equivalent experience required.
• Four years’ biotech/pharma experience with two directly with IRT systems.
• IRT development experience, protocol interpretation and IRT terminology knowledge.

Responsabilités

• Lead IRT study-team support from protocol-aligned requirements through conduct and closeout.
• Oversee vendor functionality, processes and performance through routine issue-resolution and risk-management meetings.
• Manage deployment timelines and application launches with internal teams and vendors.
• Maintain requirements, user guides, training materials and communication plans.
• Coordinate user acceptance testing.
• Coordinate randomisation and kit-list uploads with Clinical Logistics and biostatistics.
• Develop vendor-supported clinical-team and site training for investigator meetings or training.

Connaissances

IRT systems knowledge

Leadership

Negotiation

Mentoring

Coordinating

Presentation skills

Formation

Bachelor's degree or eight years’ equivalent experience

Outils

IRT systems

Description du poste

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Clinical Supply Systems Manager to join our Clinical Supply Systems Group, supporting our clinical trials in a hybrid setting. In this role, you will support Interactive Response Technology (IRT) systems while collaborating with clinical trial management, data management, biostatistics and clinical supply leads. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Mulitiple locations are being considered for this role (Hybrid)

• Lead IRT study-team support from protocol-aligned requirements through conduct and closeout.
• Oversee vendor functionality, processes and performance through routine issue-resolution and risk-management meetings.
• Manage deployment timelines and application launches with internal teams and vendors.
• Maintain requirements, user guides, training materials and communication plans.
• Coordinate user acceptance testing.
• Coordinate randomisation and kit-list uploads with Clinical Logistics and biostatistics.
• Develop vendor-supported clinical-team and site training, presenting functionality and requirements at investigator meetings or clinical research associate training when required.

You bring a collaborative, solution-focused mindset.

This role requires:

• Bachelor's degree or eight years’ equivalent experience.
• Four years’ biotechnology/pharmaceutical experience, including two directly with IRT systems.
• Clinical-trial IRT development experience, protocol interpretation and IRT/programming terminology knowledge.
• International Council for Harmonisation/Good Clinical Practice and regulatory guideline/directive knowledge.
• Microsoft Office Suite competency.
• Understanding of current and future business trends.
• Leadership, negotiation, mentoring and coaching skills.
• Multitasking, prioritisation, problem-solving, project management and organisational skills.
• Written, verbal and small/large-group presentation skills.
• Cross-functional/cross-cultural awareness and matrix-working ability.
• Disease/therapeutic-area knowledge is a plus.

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

For other locations, additional information will be provided during the recruitment process.

If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually) $114,800.00 - $187,400.00

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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.

Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company's Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.