Senior Manager managing clinical science projects within Regeneron Genetics Medicine. Overseeing clinical trials and contributing to regulatory documentation and compliance.
Responsibilities
Supports the cross-functional study team on various activities
Contributes to the writing of Clinical Study Concepts (CSCs) and Clinical Study Protocols (CSPs)
Assists with identifying collaborators/advisors and organizes consultations
Represents the clinical function on clinical study teams
Works alongside Clinical Trial Manager for day-to-day clinical input
Drafts clinical sections in regulatory and clinical documents
Reviews study related documents
Trains and supports study team and CRO personnel
Assists with medical monitoring and writing safety narratives
Organizes steering committees, advisory boards, and data safety monitoring boards
Identifies program or data risks and implements strategies
Ensures compliance with guidelines for clinical safety
Provides background literature searches in support of clinical strategy
Requirements
Bachelor’s degree
Ph.D., PharmD. or Master’s degree in biomedical subject
8 years of clinical research/development experience
Benefits
health and wellness programs (including medical, dental, vision, life, and disability insurance)
fitness centers
401(k) company match
family support benefits
equity awards
annual bonuses
paid time off
paid leaves (e.g., military and parental leave)
Job title
Senior Manager, Clinical Scientist, Genetics Medicine
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