Cytokinetics

Cytokinetics

Director, REMS Strategy & Operations

Radnor, Pennsylvania · Director

Sponsorship not specified$221k-$257kDetected 31 days ago
ComplianceProject ManagementHIPAAPatient CareFDA RegulatoryPharmacovigilanceLeadershipCommunicationCollaborationProblem SolvingGxP

About the role

  • The position offers a unique opportunity to shape and scale innovative solutions in a fast-paced, entrepreneurial, and highly collaborative environment.
  • The Director will report to the Head of Treatment Experience and may be based in Radnor, PA or South San Francisco, CA.
  • The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.

Responsibilities

  • Manage REMS compliance, audit readiness, and reporting.
  • 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 REMS Compliance Team (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.
  • 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.
  • 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.

Requirements

  • Proven experience in strategic planning, project management and optimizing organizational effectiveness.
  • Track record of successfully managing and leading vendor relationships from both a strategic and operational perspective and achieving results.
  • Exceptional interpersonal skills including the ability to communicate effectively with people individually and groups
  • ability to communicate with technical and non-technical colleagues
  • experience establishing and maintaining effective relationships across stakeholders.
  • Proven depth with analytical (qualitative and quantitative), creativity, and problem-solving skills.
  • Familiarity with deviation management, CAPA processes, and quality management systems within a GxP or regulated pharmaceutical environment.
  • Bachelor's Degree required. Advanced Degree Preferred (Pharm-D or Master's Degree).
  • 10+ years of relevant working experience in Patient Services, REMS, Drug Safety/Pharmacovigilance, or GxP-regulated operations within the pharmaceutical or biotechnology industry. Direct REMS program experience strongly preferred
  • Proven experience in strategic planning, project management and optimizing organizational effectiveness. Strategic thinker and skilled at connecting dots, prioritization and influence through storytelling.
  • In-depth familiarity of 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 (e.g., REMS portals, case management systems, or safety databases) 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.

Nice to have

  • Bachelor's Degree required.
  • Advanced Degree Preferred (Pharm-D or Master's Degree).
  • 10+ years of relevant working 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.
  • Familiarity with the FDA's REMS Integration Initiative is a plus.

Compensation

  • In the U.S., the hiring pay range for fully qualified candidates is $220,500-$257,250 per year.
  • The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.

Benefits

  • This leader will drive cross-functional collaboration to integrate compliance, access, and experience, while continuously improving processes that support patients and healthcare providers.

Equal opportunity

  • www.cytokinetics.com
  • Cytokinetics is an Equal Opportunity Employer
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This listing is sourced directly from Cytokinetics's careers page and normalized into a canonical job model.