Global Safety Medical Director

Amgen

. Serve as the accountable physician safety leader for assigned Obesity development programs .

Posted 11/6/2026full-timeRemote • United StatesLead💰 $256,607 - $347,174 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Drug Safety, Clinical Safety, and Pharmacovigilance, with a strong focus on signal detection, risk management, and regulatory submissions. Proven ability to lead cross-functional teams and influence clinical development strategies in the pharmaceutical industry.

Highest-signal resume keywords

MD Or DO DegreeGlobal Safety Officer ExperienceSignal Detection ExpertiseRegulatory Submission ExperienceLeadership In Cross-Functional Teams

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research ExperiencePharmaceutical Industry ExperienceBenefit-Risk EvaluationRisk Management PlansSafety Monitoring PlansProtocol DevelopmentCore Data Sheets DevelopmentSafety GovernanceData Monitoring Committees ParticipationAggregate Safety Reports

Soft Skills

Influencing Development StrategyDecision-MakingCommunication SkillsLeadership

Industry Keywords

Obesity Clinical DevelopmentPharmacovigilanceClinical DevelopmentSafety Analysis TeamExecutive Safety CommitteeSafety Review CommitteesHealth Authorities InteractionINDsCTAsBLAs

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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