Cytokinetics

General Counsel

• Advise on legal risks and ensure compliance with FDA, EMA, and international regulations
• Participate in Medical/Legal/Regulatory (MLR) review teams
• Support product launch preparations and lifecycle management
• Collaborate with Sales, Marketing, and Medical Affairs teams
• Draft and negotiate commercial agreements

Senior Director, Legal Counsel – Commercial

Director

• Identify national, regional, and local Key Opinion Leaders (KOLs) involved with cardiovascular care
• Maintain and broaden professional relationships with HCPs in institutional care centers
• Contributes to / leads Congress Planning activities
• Serve as a scientific expert at key medical and scientific conferences
• Maintain a high-level of scientific knowledge and understanding about disease state and treatment guidelines
• Work with Medical Affairs and other internal colleagues on initiatives including medical information and publications
• Provide support to our clinical development programs

Associate Director, Medical Scientist

• Identify national, regional, and local Key Opinion Leaders (KOLs)
• Maintain and broaden professional relationships with HCPs
• Contribute to Congress Planning activities
• Serve as a scientific expert at medical and scientific conferences
• Maintain high-level understanding about disease state and treatment guidelines
• Work with Medical Affairs on medical information, publications, and educational programs
• Provide support to clinical development programs by serving as a key point of contact
• Generate Field Medical Affairs plans

Manager

• Lead GxP system evaluations and assess vendor validation packages
• Oversee clinical study vendor GxP systems changes and lifecycle deliverables
• Ensure clinical study systems comply with applicable regulations and guidance (e.g., 21 CFR Part 11, Annex 11, ICH E6(R2/R3))
• Support internal/external audits and regulatory inspections (including audit trail review strategy)
• Maintain inspection-ready documentation
• Establish governance for change control, periodic review, and system lifecycle management
• Work on planning, design, configuration, and deployment of new clinical systems and enhancements to existing applications
• Coordinate and participate in analyzing system requirements, user acceptance testing, and system enhancements, as necessary
• Support the Development Operations team in managing systems vendor relationships on a day-to-day basis to ensure optimum system performance and to address/escalate issues, as appropriate
• Develop Standard Operating Procedures (SOPs) and guidelines related to the management and use of clinical systems
• Partner with IT, Quality Systems, and other stakeholders on clinical system bug fixes and upgrades
• Oversee governance for clinical systems, as applicable
• Work with clinical systems vendors and CRO partners to transfer, integrate, and transform clinical data and operational data to Cytokinetics systems

Contract Clinical Systems Manager

• Advise on legal risks associated with promotional and non-promotional initiatives
• Actively participate in Medical/Legal/Regulatory (MLR) review teams
• Support product launch preparations and lifecycle management
• Collaborate with Sales, Marketing, and Medical Affairs teams
• Draft, negotiate, and interpret a wide range of commercial agreements

Operations

• 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 Treatment Experience budget and forecast.
• Drive digital-first strategies for patient engagement and identify and implement technology solutions to streamline processes and enhance patient experience.
• 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.

Senior Director, Legal Counsel – Commercial

Associate Director, Medical Scientist

Associate Director, Medical Scientist

Contract Clinical Systems Manager

Senior Director, Legal Counsel – Commercial

Director, Treatment Experience Strategy – Operations