Director, REMS Strategy & Operations

Role: Lead strategy and operations for Cytokinetics' REMS programs, focusing on patient access, compliance, and stakeholder engagement. Responsibilities: manage REMS compliance, oversee program lifecycle, coordinate regulatory reporting, optimize portal systems, develop training, and lead vendor relationships. Drive continuous improvement through data analysis and KPIs, ensuring alignment with organizational and regulatory standards. Collaborate cross-functionally with legal, safety, regulatory, sales, marketing, and technology teams. Qualifications: Bachelor’s Degree required; advanced degree preferred (Pharm-D or Master’s). Over 10 years of experience in Patient Services, REMS, Drug Safety, or GxP-regulated pharma operations; direct REMS experience highly preferred. Expertise in GxP compliance, FDA guidance, and regulated systems; strong project management, strategic thinking, and stakeholder communication skills. High-Value: Focus on pharmaceutical compliance, REMS lifecycle management, regulatory reporting, and vendor oversight; familiarity with FDA REMS guidance and ETASU frameworks. Work setup: Hybrid with up to 30% travel between Radnor, PA, and South San Francisco, CA.