Senior Manager, Clinical Scientist, Genetics Medicine

Senior Manager, Clinical Scientist, Genetics Medicine

Join Regeneron to apply for the Senior Manager, Clinical Scientist, Genetics Medicine role. We are seeking a qualified scientist with training in the pharmaceutical/biotechnology sector, or academic or clinical setting, to work closely with the supervisor and other cross‑functional team members, contributing to early development and clinical experimentation from discovery phase through Proof of Concept (POC).

• Supports the cross‑functional study team on activities such as writing sections of Clinical Study Concepts (CSCs) and Clinical Study Protocols (CSPs) and amendments.
• Assists with identifying key internal and external collaborators/advisors, and 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 the 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 and manuscripts for publication.
• 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 supports study team and CRO personnel regarding clinical trial aspects.
• Assists with medical monitoring, raising and responding to investigator queries, writing safety narratives, and analyzing trends of safety and efficacy.
• Organizes steering committees, advisory boards, and data safety monitoring boards as required.
• Identifies program, trial or data risks, and creates and implements mitigation strategies.
• Ensures clinical team compliance with FDA, EMEA, ICH and GCP guidelines and 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.

• Bachelor’s degree in a biomedical subject;
  Ph.D., Pharm
  
  D, or Master’s degree preferred.
• 8+ years of clinical research/development experience.
• Effective verbal, written and presentation communication skills.
• Ability to work productively in a fast‑paced collaborative environment.
• Demonstrated or potential for critical thinking skills and sound decision‑making.

$ – $

• Seniority level:
  Mid‑Senior level
• Employment type:
  
  Full‑time
• Job function:
  Health Care Provider
• Industry: Biotechnology

Regeneron offers a comprehensive benefits package that varies by location. In the U.S., benefits may include health and wellness programs (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.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.

The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.