Regeneron

Program Manager

• Responsible for leadership of and setting and implementation of the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM)
• Maintain overview of clinical program(s) status and issues and proactively communicate progress, risks, issues or changes
• Oversee clinical study budgets within a program
• Ensure timely delivery of quality operational deliverables and ensure consistency of process across clinical study teams

Director, Program Operations Leader – Ophthalmology/Renal

• responsible for leadership of and setting and implementation of the operational strategy for delivery of complex programs in Clinical Trial Management (CTM)
• responsible for clinical operations activities and decisions including quality, timelines, and budgets related to the conduct of clinical research studies
• interact with senior-level management, external vendors, collaboration partners, and clinical study personnel
• responsible for line management of clinical trial management staff
• develop and implement operational strategy, driving early study planning budget and timelines

Director, Program Operations – Specialty Medicine, Rare Disease

• responsible for leadership and overall strategic management of one or more complex programs in Clinical Trial Management (CTM)
• responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s)
• maintain an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to stakeholders as requested
• provide operational insight into feasibility, timeline and cost estimates during clinical program/study development
• oversee clinical study timelines within a clinical program(s)

Director, Program Operations Leader – Internal Medicines

• responsible for leadership of and setting and implementation of the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM)
• responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies
• operates with autonomy and high-degree of independence
• responsible for line management of clinical trial management staff
• key role in driving the functional strategy of Clinical Trial Management

Director, Program Operations – Oncology-Hematology

Compliance

• Address global regulatory information requests from stakeholders
• Develop tailored reports to support compliance and strategy
• Monitor regulatory policies and assess their impact on drug development
• Draft policy recommendations for submission to Health Authorities
• Evaluate and optimize regulatory intelligence data sources
• Share updates to improve organizational awareness of changes
• Coordinate with Legal and Public Policy teams for consistent communication
• Identify trends and improve regulatory processes

Director, Program Operations Leader – Ophthalmology/Renal

Director, Program Operations – Specialty Medicine, Rare Disease

Director, Program Operations Leader – Internal Medicines

Director, Program Operations – Oncology-Hematology

Associate Director, Regulatory Intelligence