Global Safety Medical Director, Rare Disease

🕒 April 1

🇺🇸 United States – Remote

💵 $256.6k - $347.2k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 45%

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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 Rare Disease development programs • Lead global safety strategy for clinical development programs, primarily Phase 1b and Phase 2 studies • Partner with Clinical Development and Translational Medicine teams on 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 the Safety Analysis Team, Global Safety Team, and participate in Executive Safety Committee discussions • Review and contribute to Safety Review Committees, Data Monitoring Committees, 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, 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 • Travel domestically and internationally up to 10%

🎯 Requirements

• MD or DO degree from an accredited medical school • Completion of an accredited medical or surgical residency, or relevant clinical experience in an academic, hospital-based, or private practice setting • 8+ years of pharmaceutical industry experience in Drug Safety, Clinical Safety, Pharmacovigilance, or Clinical Development • Experience serving as a Global Safety Officer, Clinical Safety Lead, Safety Lead Physician, or equivalent accountable safety role • Experience supporting Phase 1b and Phase 2 clinical development programs • Experience in Early Clinical Development, including First-in-Human, dose escalation, cohort expansion, proof-of-concept, and translational medicine programs • 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 • Rare Disease clinical development experience strongly preferred • Expertise in inflammatory, neuroinflammatory, autoimmune, complement-mediated, vasculitis, endocrine, metabolic, genetic, or other orphan disease indications strongly preferred • Experience supporting biologics, monoclonal antibodies, gene therapies, or other innovative modalities in clinical development 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 • Sponsorship for this role is not guaranteed

🏖️ Benefits

• Health and welfare plans for staff and eligible dependents • 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, including remote and hybrid work arrangements, where possible • Career development opportunities • Reasonable accommodation for individuals with disabilities