Global Safety Medical Director, Rare Disease

About the role

The Global Safety Officer, Medical Director, Rare Disease will serve as the safety expert for the assigned product(s) within the Rare Disease portfolio. Key responsibilities include establishing safety strategies, leading safety signal assessments, and providing safety input across various documents and processes.

Responsibilities

• Validate safety signals and lead safety signal assessments
• Develop and maintain Core Safety Information (e.g., core data sheet, core risks in informed consent forms)
• Prepare/review core and regional risk management plans including additional risk minimization measures
• Prepare/review safety sections of periodic aggregate reports
• Provide safety input to protocols, statistical analysis plans, and clinical study reports
• Prepare/review safety sections of new drug applications and other regulatory filings
• Serve as safety expert on Evidence Generation Team for assigned products
• Inspection readiness

Requirements

• MD or DO degree from an accredited medical school
• Completion of an accredited medical or surgical residency
• OR
• Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
• Expertise in Rare Disease therapeutic area, or clinical training
• Experience with marketed product safety; risk management
• Experience with phase 1-3 clinical trials safety assessments and analyses
• Drug Submission experience
• Leadership experience of the safety profile of products assigned with cross-functional team members

Qualifications

• MD or DO degree from an accredited medical school
• Completion of an accredited medical or surgical residency
• OR
• Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
• Expertise in Rare Disease therapeutic area, or clinical training
• Experience with marketed product safety; risk management
• Experience with phase 1-3 clinical trials safety assessments and analyses
• Drug Submission experience
• Leadership experience of the safety profile of products assigned with cross-functional team members

Benefits

Amgen offers a comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Additional benefits include a discretionary annual bonus program, stock-based long-term incentives, and award-winning time-off plans.

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Schedule

Domestic and International travel up to 10% is expected.