Senior Manager, Clinical Scientist, Genetics Medicine
Regeneron
Full-time
On-site
Tarrytown, NY
Clinical Research and Development
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Role Summary
Senior Manager, Clinical Scientist, Genetics Medicine. 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, contribute to early development and clinical experimentation for projects from discovery through Proof of Concept (POC).
Responsibilities
- Supports the cross-functional study team on activities including but not limited to: writing sections of Clinical Study Concepts (CSCs) and Clinical Study Protocols (CSPs) and amendments; identifying collaborators/advisors and organizing consultations with global subject matter experts; representing the clinical ECD&ES function on clinical study teams and contributing medical/scientific input to compliant trial execution and deliverables; providing day-to-day clinical input to the study team alongside the Clinical Trial Manager; drafting portions of clinical sections in regulatory and clinical documents (e.g., IND/IMPD submissions, investigator’s brochures, informed consent forms, IRB/IEC submissions, clinical study reports, abstracts/manuscripts); reviewing study-related documents (medical monitoring plans, statistical analysis plans, data management plans, eCRF guidelines, data validation manuals, database UAT); training and supporting study teams and CRO personnel on clinical aspects of the trial; assisting with medical monitoring, investigator queries, safety narratives, and trend analysis; organizing steering committees, advisory boards, and data safety monitoring boards as required; identifying program/trial/data risks and implementing mitigation strategies; ensuring clinical team compliance with FDA, EMEA, ICH, and GCP guidelines and SOPs related to clinical safety; providing background literature searches for early clinical strategy, indication selection, study rationale, endpoints; supporting POC-enabling human studies, First-In-Human (FIH) studies, and clinical experimental studies as per clinical strategy.
Qualifications
- Required: Bachelor’s degree;
- Preferred: Ph.D., Pharm.D., or Master’s degree in a biomedical subject;
- 8 years of clinical research/development experience.
Skills
- Effective verbal and written communications and presentation skills
- Ability to work productively in a fast-paced, collaborative environment
- Demonstrated or potential critical thinking and sound decision-making
Education
- Bachelor’s degree required; advanced degree preferred as listed in Qualifications
Additional Requirements
- On-site work may be required; discuss location with recruiter/hiring manager
- Background checks may be conducted as part of the recruitment process