Senior Manager Global Site Management
Regeneron Pharmaceuticals
Summary
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, Global Site Management to join our Global Development team in a hybrid role supporting our global clinical trial portfolio. In this position, you will play a meaningful role in designing and leading all aspects of risk-based monitoring strategies, ensuring high-quality site management and operational execution across clinical studies. Working closely with Clinical Trial Management, Central Monitoring, Quality, and external partners, you will help drive inspection readiness, study performance, and patient-focused outcomes.
Job description
When & Where
- Location: Warren, NJ or Armonk, NY
- Work Model/Flexibility: Hybrid 3 days a week
- Shift Requirements: Standard business hours
- Travel: Up to 25%
Discover Your Role
- Lead the development and implementation of study-specific risk-based monitoring and site management strategies across global clinical programs.
- Partner with Clinical Trial Management teams to identify critical data, key study risks, and appropriate monitoring approaches.
- Provide oversight of CRO and FSP monitoring activities to ensure quality, compliance, and study execution objectives are achieved.
- Evaluate performance metrics, key risk indicators, and operational trends to proactively identify and mitigate study risks.
- Collaborate with cross-functional partners to support study planning, budget forecasting, inspection readiness, and operational excellence.
- Establish productive relationships with investigator sites, CRO partners, and internal stakeholders to drive study performance and data quality.
- Act as a subject matter expert in risk-based quality management (RBQM), monitoring strategy, and site management standards.
- Contribute to process improvement initiatives and innovation efforts that enhance clinical trial delivery and operational efficiency.
This Role Requires
- Bachelor's degree and 8+ years of proven experience in clinical research, clinical operations, site management, monitoring, or related pharmaceutical/biotechnology environments.
- Strong knowledge of clinical trial operations, risk-based monitoring methodologies, and site management practices.
- Experience working within a Risk-Based Quality Management (RBQM) framework.
- Working knowledge of ICH-GCP guidelines and applicable regulatory requirements.
- Demonstrated experience managing and overseeing CROs, Functional Service Providers (FSPs), or external clinical partners.
- Excellent communication, collaboration, organizational, and stakeholder management skills.
Preferred Qualifications
- Experience developing monitoring plans, critical data identification strategies, and targeted Source Data Verification (tSDV) approaches.
- Experience supporting global clinical studies across multiple countries and regions.
- Familiarity with performance metrics, Key Risk Indicators (KRIs), and operational risk management processes.
- Proven ability to influence cross-functional teams and drive process improvement initiatives.
- Experience participating in regulatory inspections, audits, and inspection readiness activities.
- Strong critical thinking, problem-solving, and decision-making capabilities in complex clinical development environments.
Requirements
- Bachelor's degree
- 8+ years of proven experience in clinical research, clinical operations, site management, monitoring, or related pharmaceutical/biotechnology environments
- Strong knowledge of clinical trial operations, risk-based monitoring methodologies, and site management practices
- Experience working within a Risk-Based Quality Management (RBQM) framework
- Working knowledge of ICH-GCP guidelines and applicable regulatory requirements
- Demonstrated experience managing and overseeing CROs, Functional Service Providers (FSPs), or external clinical partners
- Excellent communication, collaboration, organizational, and stakeholder management skills
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.