Director, REMS Strategy & Operations
Cytokinetics
August 21, 2026
Remote friendly (Greater Philadelphia)
United States
Operations
Responsibilities:
- Align patient services initiatives with REMS requirements, organizational goals, compliance standards, and market access strategies.
- Manage REMS compliance, audit readiness, and reporting; oversee identification, tracking, and remediation of REMS deviations and CAPAs with the REMS Compliance Team (RTC).
- Lead end-to-end REMS program strategy and operations; oversee REMS workflows, audit readiness, and reporting; support launches, updates, and lifecycle management.
- Lead operational data gathering, analysis, and narrative development for REMS Assessment reports; coordinate with RTC for final regulatory/compliance/legal/drug safety/quality review and FDA submission.
- Interface operationally with RTC on REMS program matters; prepare materials and operational updates for RTC review meetings.
- Lead operational impact assessment and implementation planning for REMS modifications; route proposed changes through RTC for approval before execution.
- Oversee the REMS portal platform (enhancements, HCP/patient UX) and coordinate with technology vendors on build, maintenance, and validation.
- Develop and oversee REMS training programs/materials for internal teams, field sales, HCPs, and pharmacy partners with RTC input.
- Oversee REMS budget and forecast.
- Manage vendor relationships; define and refine KPIs/metrics and drive continuous improvement.
Qualifications:
- Bachelor’s required; Advanced degree preferred (Pharm-D or Master’s).
- 10+ years in Patient Services, REMS, Drug Safety/Pharmacovigilance, or GxP-regulated operations; direct REMS experience strongly preferred.
- Strong strategic planning, project management, vendor leadership, interpersonal, analytical/problem-solving skills.
- Familiarity with HIPAA and federal regulations; FDA REMS guidance, assessment requirements, ETASU frameworks (plus: REMS Integration Initiative).
- Experience with GxP systems/validated platforms (REMS portals, case management, safety databases), qualification/change control/audit readiness; deviation/CAPA/quality management familiarity.
Application instructions:
- Please review the company’s GDPR policy PRIOR to applying.
- Align patient services initiatives with REMS requirements, organizational goals, compliance standards, and market access strategies.
- Manage REMS compliance, audit readiness, and reporting; oversee identification, tracking, and remediation of REMS deviations and CAPAs with the REMS Compliance Team (RTC).
- Lead end-to-end REMS program strategy and operations; oversee REMS workflows, audit readiness, and reporting; support launches, updates, and lifecycle management.
- Lead operational data gathering, analysis, and narrative development for REMS Assessment reports; coordinate with RTC for final regulatory/compliance/legal/drug safety/quality review and FDA submission.
- Interface operationally with RTC on REMS program matters; prepare materials and operational updates for RTC review meetings.
- Lead operational impact assessment and implementation planning for REMS modifications; route proposed changes through RTC for approval before execution.
- Oversee the REMS portal platform (enhancements, HCP/patient UX) and coordinate with technology vendors on build, maintenance, and validation.
- Develop and oversee REMS training programs/materials for internal teams, field sales, HCPs, and pharmacy partners with RTC input.
- Oversee REMS budget and forecast.
- Manage vendor relationships; define and refine KPIs/metrics and drive continuous improvement.
Qualifications:
- Bachelor’s required; Advanced degree preferred (Pharm-D or Master’s).
- 10+ years in Patient Services, REMS, Drug Safety/Pharmacovigilance, or GxP-regulated operations; direct REMS experience strongly preferred.
- Strong strategic planning, project management, vendor leadership, interpersonal, analytical/problem-solving skills.
- Familiarity with HIPAA and federal regulations; FDA REMS guidance, assessment requirements, ETASU frameworks (plus: REMS Integration Initiative).
- Experience with GxP systems/validated platforms (REMS portals, case management, safety databases), qualification/change control/audit readiness; deviation/CAPA/quality management familiarity.
Application instructions:
- Please review the company’s GDPR policy PRIOR to applying.