Global Safety Medical Director, Immuno-oncology - Remote

Overview

The Global Safety Medical Director will serve as the safety expert for the Rare Disease portfolio, establishing the strategy and overseeing pharmacovigilance activities while leading cross-functional teams to ensure patient safety.

In Short

• Lead safety signal assessments and validate safety signals.
• Develop and maintain Core Safety Information.
• Prepare and review risk management plans and safety sections of reports.
• Contribute to clinical study protocols and regulatory filings.
• Work within cross-functional teams to support product safety.
• Domestic and international travel up to 10%.
• MD or DO degree required.
• Experience in product safety within the biopharmaceutical industry preferred.
• Leadership experience in safety profile management.
• Join a collaborative and innovative culture at Amgen.

Requirements

• MD or DO degree from an accredited medical school.
• Completion of an accredited medical or surgical residency.
• Clinical experience in an academic or private practice setting.
• Product safety experience in the bio/pharmaceutical industry.
• Expertise in Rare Disease therapeutic areas.
• Experience with marketed product safety and risk management.
• Familiarity with phase 1-3 clinical trials safety assessments.
• Leadership experience with cross-functional teams.

Benefits

• Comprehensive employee benefits package.
• Retirement and Savings Plan with company contributions.
• Group medical, dental, and vision coverage.
• Flexible spending accounts.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote options.