Cytokinetics

QA Engineer

• Provide leadership and oversight for implementation of GxP computer system validation lifecycle and related QA-CSV / CSA strategies
• Actively support the CSV / CSA functional strategies and multi-year roadmap, and actively take part in developing parts of the strategy
• Lead internal and contract resources to manage CSV / CSA activities and ensure adequate support to meet business needs
• Participate in global/enterprise wide GxP-CSV / CSA projects and contribute to computer system validation working groups and strategies
• Manage risk assessments with functional teams to assess system risks and develop mitigations
• Provide input to CSV / CSA documentation and oversee the execution of qualification/validation activities
• Review and approve qualification/validation documentation (specifications, protocols, risk assessments, reports)
• Participate in vendor assessments and/or audits.
• Manage and/or lead CSV / CSA routine and complex audits including but not limited to internal processes, vendors and business partners
• Interact regularly with members of QA and other GXP functions to provide expert CSV / CSA compliance guidance, identify issues and support continuous improvement
• Perform CSV / CSA inspection readiness preparations and/or directly support regulatory agency inspections. Assist in the coordination of response to any findings as applicable
• Update and/or create computer system related policies, procedures, templates, forms, etc.
• Provide guidance and expertise on the validation approach in compliance with regulations to project teams as necessary
• Lead new system selection processes including requirement gathering, RFP development, and software vendor selection
• Develop and evaluate quality processes and system standards to ensure compliance with applicable procedures, industry standards and global regulations
• Identify and implement process improvements against industry best practices, regulatory guidelines and requirements
• Review and approve computer system SOPs, change controls, deviations, and CAPAs

Associate Director, QA Computer System Validation

Director

• Through development of a territory strategic plan, identify national, regional, and local Key Opinion Leaders (KOLs) involved with the provision of cardiovascular care within institutional care centers and engage them in proactive and reactive scientific exchange
• Maintain and broaden professional relationships with HCPs (physicians, NPs, PAs, nurses, and pharmacists) in institutional care centers to expand research, advisory, and educational partnership opportunities; identify areas of unmet medical need; and assure thoughtful exchange of current medical information related to products in development and therapeutic areas of importance
• Contributes to planning and execution of Congress activities. This includes review of scientific programming of relevant conferences, attending sessions, supporting exhibit booth operations, and contributing to a timely written conference report summarizing key information, activities, and competitive intelligence to colleagues
• Serve as a scientific expert at key medical and scientific conferences, advisory boards, clinical investigator meetings, internal meetings, and patient advocacy group meetings
• Maintain a high-level of scientific knowledge and understanding about disease state, underlying science, treatment guidelines, available treatment agents and options, as well as heart failure and hypertrophic cardiomyopathy therapies under development.
• Maintain a superior understanding of current trends in clinical research, competitive developments, patient care, and their impact on Cytokinetics’ medical strategies
• Work with Medical Affairs and other internal colleagues on initiatives including medical information, publications, medical education, grants, speaker training, and other educational programs
• Provide support to our clinical development programs by serving as a key point of contact for company-sponsored trial investigators, investigator-initiated research, and registries consistent with company objectives and regulations.
• Work compliantly and collaboratively with field account specialists in support of MYQORZO
• Timely and accurately respond to unsolicited requests for Medical Information
• Mentor and support Sr. Medical Science Liaison
• Provide strategic input and execute region-specific plans to achieve KOL engagement goals and Medical Affairs departmental goals
• Pursues projects independently with a high degree of quality and timely execution
• Maintains a complete awareness of and understanding about current “real world” clinical practices, HEOR drivers, and emerging trends in treatments/medicine
• Establish relationships with key executive leadership colleagues across Cytokinetics and connect external parties with appropriate leadership team members

Associate Director, Medical Science Liaison – Central & Southern Florida, Puerto Rico

• Identify national, regional, and local Key Opinion Leaders (KOLs) involved with the provision of cardiovascular care
• Maintain and broaden professional relationships with HCPs
• Plan and execute Congress activities
• Serve as a scientific expert at key medical and scientific conferences
• Maintain scientific knowledge about disease state and treatment guidelines
• Provide support to clinical development programs
• Mentor and support Sr. Medical Science Liaison

Associate Director, Medical Science Liaison – West Virginia, Virginia, Maryland, Washington, DC

• Lead sales force operations analysis, including sizing, alignment, targeting, and call planning, to optimize field effectiveness.
• Partner closely with Field Leadership and HR to design, implement, and manage incentive compensation plans for all customer-facing teams.
• Ensure timely and accurate IC reporting and payouts, working in alignment with Finance to meet budgetary and payroll standards.
• Provide strategic and ad hoc analytical support to Sales VPs, Directors, and Managers to inform field decision-making and drive commercial success.
• Collaborate with the Marketing and Commercial Analytics teams to evaluate promotional effectiveness and optimize resource allocation.
• Monitor performance vs. plan and recommend adjustments to field operations strategies, including targeting, alignment, call plans, and IC design (modeling).
• Navigate and resolve ambiguity with a problem-solving mindset and proactive approach.
• Uphold and model the company’s core values, operating with integrity and adhering to all policies and procedures.

Associate Director, Field Deployment – Incentive Compensation

Marketing

• Lead the development and execution of HCP and Patient promotional efforts for patient support, REMS, and market access
• Partner closely with promotional agency and market research vendors
• Manage agency budget to ensure cost-effective delivery
• Collaborate closely with customer facing colleagues, Treatment Experience, and Global Value Access & Distribution (GVAD)
• Develop and track metrics to measure and ensure success of marketing/promotional programs
• Liaise closely with Legal, Regulatory and Compliance to execute brand tactics efficiently

Director, Access and Experience

• Enable access to Cytokinetics’ therapeutics through assigned accounts
• Provide leadership and management in selecting, contracting, and negotiating trade agreements
• Collaborate with functional areas to support channel portfolio strategy
• Educate and liaise with SP personnel to facilitate patient access
• Monitor operations and ensure contractual obligations are met
• Develop and enhance channel ordering and inventory reports

Trade and Pharmacy Accounts Director

Pricing Analyst

• Lead end-to-end commercial analytics across key domains including Patient Services, HUB/SP data, Market Access & Payer Analytics, and Performance analysis.
• Translate complex data from patient support programs, specialty pharmacies, and HUB vendors into actionable insights to improve patient access, adherence, and program effectiveness.
• Develop and maintain analytic frameworks to monitor brand performance, patient journey metrics, and access barriers.
• Conduct payer and market access analytics including coverage dynamics, reimbursement trends, pull-through analysis, and payer policy impact on patient access.
• Support product launches and lifecycle management through ad-hoc analyses on demand trends, access constraints, patient funnel dynamics, and commercial performance.
• Partner with cross-functional stakeholders including market access, patient services, brand marketing, sales, and finance to identify key business questions and deliver data-driven recommendations.
• Lead the design and execution of advanced analytics projects using real-world data sources such as claims, specialty pharmacy data, HUB data, and payer data.
• Manage and prioritize multiple analytics projects while ensuring high-quality deliverables and timely insights for leadership.
• Guide and mentor external analytics vendors where applicable.
• Present analytical insights and strategic recommendations to senior commercial leadership in clear, business-focused narratives.