Global Safety Medical Director - Rare Disease

March 18

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Logo of Amgen

Amgen

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

Biologics • Human therapeutics • Development of novel products

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 Post-IPO Debt on 2022-12

📋 Description

• Join Amgen’s Mission of Serving Patients • Establish the strategy, direction, and priorities of pharmacovigilance activities • Lead the Safety Analysis Team (SAT), Global Safety Team (GST) • Validate safety signals and lead safety signal assessments • Develop and maintain Core Safety Information • Prepare/review core and regional risk management plans • Provide safety input to protocols, statistical analysis plans, and clinical study reports • Prepare/review safety sections of new drug applications • Serve as safety expert on Evidence Generation Team for assigned products

🎯 Requirements

• Doctorate degree and 4 years of Safety experience OR Master’s degree and 7 years of Safety experience OR Bachelor’s degree and 9 years of Safety experience • Product safety in the bio/pharmaceutical industry or regulatory agency • 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

• 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 • Flexible spending accounts • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models, including remote and hybrid work arrangements, where possible

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