Director, REMS Strategy & Operations
Cytokinetics · Radnor, PA
SafetyFull-time$221k–$257kCompany career page
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Role summary
Cytokinetics seeks a Director to lead REMS strategy and operations, managing risk evaluation programs, patient access initiatives, and regulatory compliance. The role involves cross-functional leadership, vendor oversight, and continuous process improvement to support cardiovascular biopharmaceutical programs.
What they're looking for
- Bachelor's degree required; advanced degree (Pharm-D or Master's) preferred
- 10+ years in patient services, REMS, drug safety, or GxP-regulated pharmaceutical operations
- Direct REMS program experience strongly preferred
- Strategic planning, project management, and vendor relationship management expertise
- In-depth knowledge of FDA REMS guidance, ETASU frameworks, and HIPAA compliance
- Experience with GxP systems, validated technology platforms, and audit readiness processes
- Exceptional communication and cross-functional stakeholder management skills
What you'll be doing
- Align patient services initiatives with REMS requirements, compliance standards, and market access strategies
- Oversee REMS compliance, audit readiness, deviation tracking, and corrective action management
- Lead end-to-end REMS program strategy, operations, and lifecycle management across launches and updates
- Prepare operational data and narratives for REMS Assessment reports submitted to FDA
- Manage REMS portal platform enhancements, user experience optimization, and vendor coordination
Privacy & handoff
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