Director, REMS Strategy & Operations

Cytokinetics, Inc.; Radnor (Delaware County); Hybrid; USD 220,500 - 257,250; Full time

Job summary

Cytokinetics, Inc. is hiring a Director, REMS Strategy & Operations to enhance patient access through strategic initiatives. This role is pivotal in aligning REMS regulations with operational effectiveness.

Preferred candidates hold a Pharm-D or Master’s degree, possess 10+ years experience in relevant fields, and demonstrate strong strategic planning and project management skills.

The position allows for remote work within the U.S., requiring up to 30% travel, with a pay range of $220,500–$257,250 annually.

Qualifications

• 10+ years of relevant experience in Patient Services or REMS.
• Proven experience in managing vendor relationships.
• In-depth familiarity with compliance regulations and REMS assessment requirements.

Responsibilities

• Lead the development and execution of REMS strategies.
• Oversee REMS program compliance and operational workflows.
• Collaborate with cross-functional teams to support strategies.

Skills

Strategic planning

Project management

Analytical skills

Interpersonal skills

Influencing skills

Education

Bachelor’s Degree

Pharm-D or Master’s (preferred)

Tools

GxP-compliance systems

FDA REMS guidance documents

Job description

The Director, REMS Strategy & Operations will lead the development and execution of strategic initiatives to enhance patient access through Risk Evaluation and Mitigation Strategies (REMS). The role provides strategic leadership across REMS and REMS‑adjacent patient services, ensuring alignment of regulatory requirements with a cohesive patient‑centric operational design.

Locations: Radnor, PA or South San Francisco, CA. Reports to the Head of Treatment Experience.

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‑related deviations and CAPAs, partnering with the REMS Compliance Team (RTC) to ensure corrective actions are appropriately scoped, implemented, and closed in a timely manner.
• Lead end‑to‑end REMS program strategy and operations, ensuring regulatory compliance while optimizing patient access, provider experience, and program effectiveness.
• Oversee REMS operational workflows, audit readiness, and reporting; support launches, updates, and lifecycle management of REMS programs.
• Lead the operational data gathering, analysis, and narrative development for REMS Assessment reports, coordinating with the RTC for final regulatory, compliance/legal, drug safety, and quality review and approval prior to FDA submission.
• Serve as the operational lead interfacing with the RTC on REMS program matters, ensuring that strategic and operational decisions are informed by regulatory, compliance, drug safety, and quality input.
• Prepare materials and operational updates for RTC review meetings.
• Lead the operational impact assessment and implementation planning for REMS modifications, routing proposed changes through the RTC for regulatory and compliance approval before execution.
• Oversee the REMS portal platform, including system enhancements, user experience optimization for HCPs and patients, and coordination with technology vendors on build, maintenance, and validation activities.
• Develop and oversee REMS training programs and materials for internal teams, field sales, HCPs, and pharmacy partners, with RTC input on regulatory and compliance content accuracy.
• Provide oversight of the REMS budget and forecast; manage vendor relationships to deliver high quality services and operational excellence for both providers and patients.
• Define and refine key performance metrics by leveraging patient analytics, customer feedback, benchmarking, and compliance monitoring to drive continuous improvement in program outcomes, including KPI achievement, operational efficiency, and cycle time reduction.
• Demonstrate a comprehensive understanding of the patient and provider journey, and identify potential barriers to their onboarding experience.
• Collaborate and work cross‑functionally with all external vendors and internal stakeholders (Sales, Marketing, Market Access, Trade, Compliance, Commercial Operations, Legal, Drug Safety, Regulatory, and Quality) to support impactful strategies.

Qualifications

• Bachelor’s Degree required; advanced degree preferred (Pharm‑D or Master’s).
• 10+ years of relevant experience in Patient Services, REMS, Drug Safety/Pharmacovigilance, or GxP‑regulated operations within the pharmaceutical or biotechnology industry.
• Direct REMS program experience strongly preferred; candidates with deep GxP compliance backgrounds who can apply regulated‑operations expertise to REMS program management will also be considered.
• Proven experience in strategic planning, project management, and optimizing organizational effectiveness.
• Strategic thinker with strong prioritization and influence skills, skilled at connecting dots and storytelling.
• Track record of successfully managing and leading vendor relationships from both a strategic and operational perspective.
• Exceptional interpersonal skills, including the ability to communicate effectively with technical and non‑technical colleagues and to establish and maintain relationships across stakeholders.
• Proven depth with analytical (qualitative and quantitative), creative, and problem‑solving skills.
• In‑depth familiarity with pharmaceutical manufacturer compliance requirements, HIPAA regulations, and federal regulations.
• Working knowledge of FDA REMS guidance documents, REMS assessment requirements, and ETASU frameworks.
• Familiarity with the FDA’s REMS Integration Initiative is a plus.
• Experience with GxP‑regulated systems and validated technology platforms, including involvement in system qualification, change control, and audit readiness.
• Experience preparing operational data and documentation to support regulatory submissions, audits, or compliance reviews in a cross‑functional governance structure.
• Familiarity with deviation management, CAPA processes, and quality management systems within a GxP or regulated pharmaceutical environment.

Travel: This position requires up to 30% travel, primarily to vendor locations and between corporate offices in Radnor, PA and South San Francisco, CA.

Pay range: $220,500–$257,250 per year (U.S.).

Cytokinetics is an Equal Opportunity Employer.