Clinical Science Senior Manager

Job Summary

A company is looking for a Senior Manager, Clinical Science.

Key Responsibilities

• Lead development and execution of Clinical Evidence Plans (CEP) aligned with product lifecycle needs
• Provide scientific leadership for device clinical studies and review clinical documentation
• Collaborate with cross-functional teams to ensure compliance and support regulatory submissions

Required Qualifications

• Degree in life sciences required; clinical background preferred
• 6-10+ years of experience in clinical science or medical affairs within medical devices
• Hands-on experience with device clinical studies and regulatory documentation
• Experience with FDA and EU MDR regulatory interactions preferred
• 8-10 years of clinical safety experience and adverse event reporting