Global Safety Medical Director – Global Safety Officer, Oncology

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $256.6k - $347.2k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $28.5G Post-IPO Debt on 2022-12

Biotechnology • Pharmaceuticals • Science

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.

📋 Description

• Safety expert of the assigned product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities. • Accountable for the overall safety profile and all product-related decisions and deliverables for assigned products. • Leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). • Product safety profile, benefit-risk evaluation, and risk communication • Clinical trial safety Brochure and Informed Consent Form • New drug applications and other regulatory filings • Risk management and minimization • Commercialization Process • Inspection Readiness • Partnerships and integration activities • Participate in safety agreement development and review process • Prepare safety information to support licensing partners, review safety documents prepared by licensing partners, and communicate with licensing partners on safety matters per the safety agreement

🎯 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 • 2+ years of industry Global Safety experience • Oncology experience in early development. • Product safety in the bio/pharmaceutical industry or regulatory agency • Previous management and/or mentoring experience • Experience with oncology products/early development

🏖️ 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 • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible