Senior Clinical Sciences Lead, Internal Medicine – Hybrid

Regeneron Pharmaceuticals, Inc; Cambourne; Hybrid; GBP 112,000 - 157,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc is seeking a Senior Manager, Clinical Sciences (Internal Medicine) to lead design and execution of cardiovascular, renal, and metabolic studies. You will work with Medical Directors and cross-functional teams to ensure data integrity and patient safety.

The role involves authoring study documents, reviewing protocols, and contributing to safety monitoring meetings, while upholding GCP standards and regulatory requirements.

Qualifications

• MS/PhD/PharmD in a related field with 8+ years of pharma clinical development experience.
• Strong knowledge of GCP, ICH guidelines, study design and clinical research methodology.
• Excellent medical writing, analytical and presentation skills.

Responsibilities

• Partner with Medical Directors to deliver scientific expertise for designing and running clinical studies.
• Contribute to clinical study teams, program team meetings, advisory boards, steering committees, and data/safety monitoring meetings.
• Support early and late-phase studies by developing protocol synopses and authoring or reviewing protocols and amendments.
• Author and review study documents including medical monitoring plans and SAPs.
• Perform clinical and medical data review, including safety monitoring.
• Collaborate with internal functions and external vendors to promote study integrity.
• Identify risks and recommend mitigations by analyzing study objectives and design.
• Maintain deep knowledge of disease area, mechanism of action, and drug landscape while upholding FDA/EMA/ICH/GCP standards.

Education

MS/PhD/PharmD in a related field

Job description

Regeneron Pharmaceuticals, Inc is seeking a Senior Manager, Clinical Sciences (Internal Medicine) to lead design and execution of cardiovascular, renal, and metabolic studies. You will work with Medical Directors and cross-functional teams to ensure data integrity and patient safety.

The role involves authoring study documents, reviewing protocols, and contributing to safety monitoring meetings, while upholding GCP standards and regulatory requirements.