Senior Manager, Clinical Scientist, Genetics Medicine

Regeneron Pharmaceuticals, Inc; Cambourne; Híbrido; GBP 105 000 - 135 000; Tempo integral

Resumo da oferta

Regeneron Pharmaceuticals, Inc is seeking a Senior Manager to join the Clinical Sciences team within Regeneron Genetics Medicine, supporting early clinical development from discovery through Proof of Concept.

You will contribute to clinical strategy, study execution, and collaboration across study teams in a fast-paced environment.

Qualificações

• Bachelor’s degree and 8+ years of clinical research/development experience.
• PhD, PharmD, or Master’s in biomedical field preferred.
• Experience drafting regulatory and clinical documents.
• Strong written and verbal communication and presentation skills.
• Experience in early-phase development is preferred.

Responsabilidades

• Represent the clinical genetics medicine function on study teams.
• Contribute to Clinical Study Concepts, protocols, and amendments with literature research.
• Draft clinical sections of regulatory and clinical documents (briefing books, submissions, IBs, consent forms).
• Review key study documents such as medical monitoring plans and SAPs.
• Partner with Clinical Trial Managers to provide day-to-day clinical input and train CRO personnel.
• Support medical monitoring, investigator queries, safety narratives, and trend analysis.
• Organize steering committees, advisory boards, and DSMBs with global experts.
• Identify program, trial, and data risks and implement mitigation strategies per FDA/EMEA/ICH/GCP.

Conhecimentos

Clinical research

Regulatory submissions

Medical writing

Cross-functional collaboration

Verbal & written communication

Formação académica

Bachelor's degree in biomedical field

PhD/PharmD/Master’s preferred

Descrição da oferta de emprego

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager to join our Clinical Sciences team within Regeneron Genetics Medicine, supporting early clinical development in a fast-paced, collaborative environment. In this role, you will contribute to clinical strategy and study execution from the discovery phase through Proof of Concept, helping translate genetic insights into potential new treatments. You will collaborate closely with your supervisor, Clinical Trial Managers, and cross-functional study teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: Tarrytown, NY, Warren, NJ, Cambridge, MA
• Work model/flexibility: Primarily On-site with hybrid flexibility

Discover your role:

• Represent the clinical genetics medicine function on study teams, contributing medical and scientific expertise to compliant, high-quality trial execution
• Contribute to Clinical Study Concepts, protocols, and amendments, supported by literature research on indication selection, rationale, and endpoints
• Draft clinical sections of regulatory and clinical documents, including briefing books, IND/IMPD submissions, investigator’s brochures, consent forms, and study reports
• Review key study documents such as medical monitoring plans, statistical analysis plans, and data management materials
• Partner with Clinical Trial Managers to provide day-to-day clinical input and train study team and CRO personnel on clinical aspects of the trial
• Support medical monitoring, investigator queries, safety narratives, and trend analysis of safety and efficacy data
• Organize steering committees, advisory boards, data safety monitoring boards, and consultations with global subject matter experts
• Identify program, trial, and data risks and implement mitigation strategies, while ensuring compliance with FDA, EMEA, ICH, and GCP guidelines

This role requires:

• Bachelor’s degree and 8+ years of clinical research/development experience
• Preferred: PhD, PharmD, or Master’s degree in a biomedical subject
• Training as a scientist in the pharmaceutical or biotechnology sector, or in an academic or clinical setting
• Effective verbal and written communication and presentation skills
• Ability to work productively in a fast-paced, collaborative environment
• Demonstrated or potential critical thinking skills and sound decision-making
• Preferred: Experience in early-phase development, including First-In-Human and Proof of Concept studies