Regeneron

Director

• engage with key opinion leaders, healthcare providers, and investigators
• craft the understanding of Regeneron’s therapies
• support clinical development and investigator-initiated research
• contribute to impactful product launches
• building and handling relationships with KOLs in Oncology
• act as a primary clinical/scientific contact for HCPs and investigators
• share medical insights to advise strategy and development plans
• support clinical trial execution by identifying investigators and trial sites
• collaborate on abstracts, posters, and manuscripts to communicate data
• attend medical congresses to gather and report competitive intelligence
• partner cross-functionally with Medical Affairs, Commercial, and Market Access

Associate Director, Field Medical Affairs – Oncology

• Lead and/or oversee the efforts of the Biostatistics department with cross-functional teams
• Partner with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical Scientists, Statistical Programming, Data Management, and Medical Writing to design and analyze clinical trials
• Guide staff in preparing materials for regulatory interactions
• Identify gaps in processes and lead working groups to implement improvements
• Mentor and oversee junior statisticians

Director, Biostatistics – Genetics Medicine

Manager

• Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact for leadership and oversight
• Provides operational input into protocol development
• Oversees the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
• Ensures compliance with the clinical trial registry requirements
• Identifies outsourcing needs of the study and leads engagement, contracting and management of required vendors
• Provides input into baseline budget development and management
• Leads risk assessment and identifies risk mitigation strategies at the study level
• Monitors progress for site activation and monitoring visits and acts on any deviations from plan
• Monitors data entry and query resolution and acts on any deviations from agreed metrics
• Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
• Manages and oversees study close-out activities including database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability

Associate Director, Field Medical Affairs – Oncology

Director, Biostatistics – Genetics Medicine

Senior Manager, Clinical Study Lead – Hematology-Oncology