Director, REMS Strategy & Operations

Cytokineticsis a specialty cardiovascular biopharmaceutical company building on its over 25 years of pioneering scientific innovations in muscle biology and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.

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). This role provides strategic leadership across REMS and REMS-adjacent patient services ensuring alignment of regulatory requirements with a cohesive patient-centric operational design.

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

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 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. 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 (i.e. Sales Marketing Market Access Trade Compliance Commercial Operations Legal Drug Safety Regulatory and Quality) to support impactful strategies.

Qualifications:

• Bachelors Degree required. Advanced Degree Preferred (Pharm-D or Masters 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.

• Proven experience in strategic planning project management and optimizing organizational effectiveness. Strategic thinker and skilled at connecting dots prioritization and influence through storytelling.

• 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.

• 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 FDAs 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.

• Familiarity with deviation management CAPA processes and quality management systems within a GxP or regulated pharmaceutical environment.

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

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Pay Range:

Our employees come from different backgrounds and we celebrate those differences. We are looking for the best candidates for our open roles but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team we would love to hear from you.

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Our passion is anchored in robust scientific thinking grounded in integrity and critical thinking. We keep the patient front and center in all we do all actions and decisions are in service of the patient and their caregivers. We champion integrity ethics doing the right thing and being our best selves.

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Cytokinetics is an Equal Opportunity Employer