Senior Manager, Clinical Scientist, Genetics Medicine
About The Position
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). As a Senior Manager, a typical day may include the following: 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 in terms of indication selection, study rationale, scientific/clinical endpoints POC-enabling human studies, First-In-Human (FIH) studies, clinical experimental studies as per clinical strategy
Requirements
- Bachelor's degree. Ph.D., PharmD. or Master's degree in biomedical subject
- 8 years of clinical research/development experience
- Effective communications (verbal & written) and presentation skills are essential
- Must be able to work productively in a fast-paced collaborative environment
- Demonstrated/potential for critical thinking skills and sound decision-making
Responsibilities
- Supports the cross-functional study team
- 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 in terms of indication selection, study rationale, scientific/clinical endpoints
- POC-enabling human studies, First-In-Human (FIH) studies, clinical experimental studies as per clinical strategy
Benefits
- comprehensive benefits, which vary by location. In the U.S., benefits may include 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, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Chemical Manufacturing
Number of Employees
5,001-10,000 employees
