Global Safety Medical Director

🔥 0 minutes 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

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

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

• Serve as the accountable physician safety leader for assigned Obesity development programs • Lead global safety strategy for clinical development programs • Partner with Clinical Development and Translational Medicine teams to inform dose-escalation, cohort expansion, proof-of-concept, and development decisions • Provide medical safety leadership and contribute to benefit-risk evaluations throughout clinical development • Review and interpret emerging safety data and communicate safety implications to development teams and governance committees • Lead Safety Analysis Team (SAT) and Global Safety Team (GST), and participate in Executive Safety Committee (ESC) discussions • Review and contribute to Safety Review Committees (SRCs), Data Monitoring Committees (DMCs), and other safety governance forums • Validate safety signals and lead signal detection, assessment, and risk evaluation activities • Develop and maintain Core Safety Information including Core Data Sheets and informed consent safety language • Prepare and review Risk Management Plans (RMPs), risk minimization strategies, and aggregate safety reports • Lead safety review and provide strategic input into protocol development, CRF design, Statistical Analysis Plans, Clinical Study Reports, and safety monitoring plans • Prepare and review safety sections of regulatory submissions including INDs, CTAs, BLAs, NDAs, and other global submissions • Serve as the safety representative on Evidence Generation Teams and other cross-functional development teams • Support regulatory inspections and inspection readiness activities • Partner with Clinical Development, Translational Medicine, Regulatory, Biostatistics, and Medical Affairs to influence development strategy and support innovative therapies

🎯 Requirements

• MD or DO degree from an accredited medical school • 2 years of clinical research experience and/or basic science research • 4+ years of pharmaceutical industry experience in Drug Safety, Clinical Safety, Pharmacovigilance, or Clinical Development preferred • Demonstrated experience serving as a Global Safety Officer (GSO), Clinical Safety Lead, Safety Lead Physician, or equivalent accountable safety role • Direct experience influencing clinical development through protocol development, CRF design, safety monitoring plans, dose-escalation decisions, and benefit-risk assessments • Expertise in signal detection, signal assessment, benefit-risk evaluation, risk management, and safety governance • Experience supporting regulatory submissions and interactions with health authorities, including INDs, CTAs, BLAs, NDAs, MAAs, and responses to regulatory questions • Experience presenting safety assessments and recommendations to governance committees, development teams, and regulatory authorities • Experience supporting Obesity clinical development programs strongly preferred • Demonstrated leadership in cross-functional matrix organizations with the ability to influence development strategy and drive decision-making • Experience with both clinical development and post-marketing safety activities preferred • Willingness to undertake domestic and international travel up to 10%

🏖️ Benefits

• Comprehensive employee benefits package • Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • Discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Financial plans with opportunities to save towards retirement or other goals • Career development opportunities • Work/life balance

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