Cytokinetics

QA Engineer

• Serve as the CQA audit program process owner
• Principal lead auditor for GCP, GVP, and GLP audits
• Develop, implement, and maintain a risk-based global clinical audit program
• Analyze and manage audit program metrics
• Lead inspection readiness activities for global health authority inspections
• Assist with quality review of key clinical documents
• Design and conduct GCP Training for functional departments
• Provide mentoring and oversight to QA staff

Associate Director, Clinical Quality Assurance Auditor

Medical Director

• Serves as a source of medical expertise for clinical project teams
• Provides input to decisions that have medical, scientific, and future marketing implications
• Provides medical input into the design, planning, initiation and completion of clinical trials
• Responsible for the preparation of the medical components of study protocols and IND and other regulatory submissions
• Serves as the medical monitor for the successful conduct, integrity, and safety of patients in our clinical trials
• Partner with Research, Regulatory Affairs, Medical Affairs, Biometrics, Clinical Operations, Safety, Quality Assurance, Product Development, Business Development, and Management to formulate and implement comprehensive clinical trial plans
• Establishes communications and relationships with prominent clinical investigators in the area of cardiovascular disease
• Attends appropriate scientific meetings to maintain awareness of research activities and represents a project and/or Company at such external events
• Applies the strategic intent of the Company when working with regulatory bodies such as FDA, and with key opinion leaders
• Performs product safety medical reviews for assigned investigational drugs
• Ensures an appropriate level of customer service to internal and external customers

Associate Director, Clinical Quality Assurance Auditor

Associate Medical Director, Clinical Research, Cardiovascular