Senior Hematology Clinical Science Lead

Regeneron Pharmaceuticals, Inc.; Kentucky; On-site; USD 150,000 - 190,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Senior Manager, Hematology Clinical Sciences to join our Clinical Sciences team, supporting hematology programs in a matrixed environment.

You will contribute to planning, execution, and data interpretation of clinical studies across early and late development, ensuring data integrity and patient safety. You will collaborate with Medical Directors and cross-functional partners, author and review study documents, monitor safety, and help drive regulatory

Qualifications

• 8+ years of pharmaceutical clinical drug development experience.
• Advanced degree in life sciences or healthcare (PhD, MD, PharmD, or MSc).
• Knowledge of the drug development process, Good Clinical Practice (GCP), study design, and medical writing.

Responsibilities

• Partner with Medical Directors to design and deliver clinical studies and programs.
• Contribute to program team meetings, advisory boards, steering committees, and data/safety monitoring meetings.
• Build and maintain understanding of the disease area, drug candidate, mechanism of action, and drug landscape.
• Assist with developing the Expanded Synopsis and author or review clinical sections of protocols, amendments, and study reports.
• Author or review medical monitoring plans, SAPs, and informed consents, and support regulatory document development.
• Perform clinical data review and safety monitoring, promoting consistent review practices across assigned studies.
• Identify critical risks and recommend mitigations, while maintaining compliance with FDA, EMEA, ICH, and GCP guidelines.
• Influence within and across teams with clear, concise communication and creative problem-solving.

Skills

Cross-functional collaboration

Pharmacology knowledge

Clinical trial design

Medical writing

FDA/ICH guidelines

Education

Advanced degree in life science or healthcare (PhD, MD, PharmD, or MSc)

Job description

Regeneron Pharmaceuticals, Inc. seeks a Senior Manager, Hematology Clinical Sciences to join our Clinical Sciences team, supporting hematology programs in a matrixed environment.

You will contribute to planning, execution, and data interpretation of clinical studies across early and late development, ensuring data integrity and patient safety. You will collaborate with Medical Directors and cross-functional partners, author and review study documents, monitor safety, and help drive regulatory