Ophthalmology Clinical Studies Lead

Regeneron Pharmaceuticals; Cambridge; Vor Ort; GBP 113.000 - 184.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals is seeking a Senior Manager in Clinical Sciences to lead the scientific strategy behind ophthalmology clinical studies, from design through execution and reporting. You will partner with Medical Directors and cross-functional teams, shape protocols, and ensure high-quality data review while safeguarding patient safety across multiple studies.

This role emphasizes strong medical writing, regulatory knowledge, and cross-functional collaboration within a matrix

Qualifikationen

• MS/PhD/PharmD in a related scientific field.
• Experience in ophthalmology clinical trials preferred.
• GCP, ICH guidelines, clinical trial design, and regulatory requirements.
• Strong medical writing skills and clinical research methodology expertise.
• Cross-functional collaboration in a matrix organization.

Aufgaben

• Lead the scientific strategy behind clinical studies from design through execution and reporting.
• Partner with Medical Directors and cross-functional teams to shape protocols, amendments, and study conduct.
• Build deep expertise in disease biology, compound mechanism of action, and competitive landscape.
• Author and review key trial documents including expanded synopses, monitoring plans, and study reports.
• Safeguard patient safety through ongoing clinical and medical data review.
• Identify risks to study integrity early and drive practical mitigation strategies.
• Represent Clinical Sciences on program teams, steering committees, and safety monitoring boards.
• Champion consistent, high-quality data review practices across assigned studies.

Ausbildung

MS/PhD/PharmD in related scientific field

Jobbeschreibung

Regeneron Pharmaceuticals is seeking a Senior Manager in Clinical Sciences to lead the scientific strategy behind ophthalmology clinical studies, from design through execution and reporting. You will partner with Medical Directors and cross-functional teams, shape protocols, and ensure high-quality data review while safeguarding patient safety across multiple studies.

This role emphasizes strong medical writing, regulatory knowledge, and cross-functional collaboration within a matrix