Manager Clinical Supply Systems
Regeneron Pharmaceuticals
Summary
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.
Job description
Discover your role
- 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.
Requirements
- Bachelor’s degree or eight years’ equivalent experience
- Four years’ biotechnology/pharmaceutical experience
- Two years directly with IRT systems
- Clinical-trial IRT development experience
- Protocol interpretation and IRT/programming terminology knowledge
- ICH/GCP 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
Benefits
- Annual bonuses
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.