Senior Immunology Clinical Sciences Leader

Regulatory Jobs; Village of Tarrytown (NY); Sur place; USD 151 000 - 246 000; Plein temps

Résumé du poste

Regeneron is seeking a Senior Manager in Clinical Sciences to lead study design, execution, and reporting for Immune/Inflammatory programs. You will collaborate with Medical Directors and multifunctional teams to shape protocols and oversight, ensuring rigorous data quality and patient safety across early to late-phase trials.

The role emphasizes disease biology, mechanism of action, and landscape analysis, requiring 8+ years in pharma development and strong medical writing expertise.

Qualifications

• Must have MS/PhD/PharmD with 8+ years in pharmaceutical clinical drug development.
• Proven knowledge of GCP, ICH guidelines, regulatory requirements.
• Strong medical writing skills and clinical research methodology expertise.

Responsabilités

• 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, mechanism of action, and the competitive treatment 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.

Connaissances

GCP and ICH knowledge

Clinical trial design

Medical writing

Cross-functional teamwork

Immune/Inflammatory experience

Formation

MS/PhD/PharmD in related field

Description du poste

Regeneron is seeking a Senior Manager in Clinical Sciences to lead study design, execution, and reporting for Immune/Inflammatory programs. You will collaborate with Medical Directors and multifunctional teams to shape protocols and oversight, ensuring rigorous data quality and patient safety across early to late-phase trials.

The role emphasizes disease biology, mechanism of action, and landscape analysis, requiring 8+ years in pharma development and strong medical writing expertise.