Global Safety Associate Director - Obesity

3 days ago

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Amgen

WebsiteLinkedInAll Job Openings

Biologics • Human therapeutics • Development of novel products

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 Post-IPO Debt on 2022-12

Description

• The Global Safety Associate Director will work within the Therapeutic Safety Teams and will be responsible for safety deliverables for assigned Amgen products throughout product life-cycles. • Support and provide oversight with regards to safety in clinical trials by providing inputs on study protocols, statistical analysis plans, other study related documents and review of safety data from clinical studies. • Direct the planning, preparation, writing and review of portions of aggregate reports. • Organize and direct liaison for activities with affiliates and other internal Amgen partners regarding products. • Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents. • Review of AEs/SAEs from clinical trials as needed. • Author Safety Assessment Reports and other safety documents and regulatory responses.

Requirements

• Doctorate degree and 3 years of Safety/Pharmacovigilance experience OR Master’s degree and 5 years of Safety/Pharmacovigilance experience OR Bachelor’s degree and 7 years of Safety/Pharmacovigilance experience OR Associate’s degree and 12 years of Safety/Pharmacovigilance experience OR High school diploma/GED and 14 years of Safety/Pharmacovigilance experience. • Experience in Obesity therapeutic area. • Experience in clinical studies with large number of participants and data sets. • Experience working at a leadership level. • Experience mentoring and developing others.

Benefits

• 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. • A discretionary annual bonus program. • Stock-based long-term incentives. • Award-winning time-off plans and bi-annual company-wide shutdowns. • Flexible work models, including remote work arrangements, where possible.