Senior Manager, Clinical Scientist, Genetics Medicine

Role Summary

We are seeking a Senior Manager to join our Clinical Sciences team within Regeneron Genetics Medicine. Qualified scientist with training in the pharmaceutical/biotechnology sector, or academic or clinical setting. You will work closely with supervisor and other members of the cross-functional team, contributes to early development and clinical experimentation for projects for discovery phase through Proof of Concept (POC).

Responsibilities

• Supports the cross-functional study team on the following activities, including but not limited to
• Contributes to the writing of sections of Clinical Study Concepts (CSCs) and Clinical Study Protocols (CSPs) and amendments
• Assists with identifying key internal and external collaborators/advisors, organizes consultations with global subject matter experts
• Represents the clinical ECD&ES function on clinical study teams, contributing medical/scientific knowledge to timely and compliant clinical trial execution and quality of deliverables
• Works alongside Clinical Trial Manager to provide day-to-day clinical input to the study team
• Drafts portions of the clinical sections in regulatory and clinical documents such as: regulatory agency briefing books, IND/IMPD submissions, investigator’s brochure, informed consent forms, IRB/IEC submissions, clinical study reports, abstracts/manuscripts for publication, etc.
• Reviews study related documents such as: medical monitoring plans, statistical analysis plans, data management plan, eCRF completion guidelines, data validation manuals, database UAT, etc
• Trains and support study team and CRO personnel regarding clinical aspects of trial
• Assist with medical monitoring, raising and responding to investigator queries, writing safety narratives, analysis of trends of safety and efficacy, etc.
• Organizes steering committees, advisory boards, and data safety monitoring boards as required
• Identifies program, trial or data risks, creates and implements mitigation strategies
• Ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety
• Provides background literature searches in support of early clinical strategy, including indication selection, study rationale, scientific/clinical endpoints
• Supports POC-enabling human studies, First-In-Human (FIH) studies, clinical experimental studies as per clinical strategy

Qualifications

• Required: Bachelor’s degree; 8 years of clinical research/development experience
• Preferred: Ph.D., PharmD or Master’s degree in biomedical subject

Skills

• Effective communications (verbal & written) and presentation skills
• Ability to work productively in a fast-paced collaborative environment
• Demonstrated/potential for critical thinking skills and sound decision-making

Education

• Bachelor’s degree required
• Advanced degrees (Ph.D., PharmD, or Master’s) preferred for advanced qualifications