Senior Manager, Clinical Science

Description

Role Summary

The Senior Manager, Clinical Science provides clinical and scientific leadership for medical device evidence generation across the product lifecycle, from clinical evaluation and regulatory submissions through safety event management in clinical trials and real-world evidence.

This role serves as the clinical subject matter expert for assigned devices, ensuring clinical evidence support for regulatory compliance, physician adoption, and patient outcomes. The position works closely with Clinical Operations, Regulatory Affairs, Quality, and Medical Affairs. The role involves strategic planning and cross-functional team leadership projects, ensuring all activities are executed in a compliant manner.

Key Responsibilities

Clinical Evidence Strategy (Medical Device–Focused)

• Lead development and execution of Clinical Evidence Plans (CEP) aligned with product lifecycle needs in the context of EU MDR requirement...