Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, we are developing small molecule drug candidates specifically engineered to impact muscle function and contractility. 

Proud to be a San Francisco Business Times Best Place to Work in 2021 and 2022, a Great Place to Work-Certified company in 2022 and a part of Fortune's Best Workplaces in the Bay Area in 2022 and Fortune's Best Workplaces in BioPharma in 2022.

Cytokinetics

Compliance

Lead regulatory labeling for drug candidates in a biopharmaceutical context.

• Cytokinetics is a biopharmaceutical company focused on muscle activators and inhibitors.
• Lead Global Labeling for development and marketed products.
• Collaborate with stakeholders for regulatory compliance.
• Review and implement labeling changes with Health Authorities.
• Maintain knowledge of global labeling regulations and practices.

Director, Regulatory Labeling

Support regulatory systems and tools implementation and training for Cytokinetics.

• Cytokinetics is seeking an Associate Director, Regulatory Systems & Training to support implementation, maintenance/upgrades, and usage of Regulatory Affairs systems and tools including EDMS, RIM Systems, publishing systems, and authoring templates.
• This role will serve as the business administrator for Cytokinetics’s EDMS, RIM, and publishing systems, and support the development, validation, and day-to-day use/troubleshooting of Regulatory systems.

Associate Director, Regulatory Systems and Training

Lead product development efforts for innovative muscle therapies addressing cardiac performance.

• Play a leading role in all aspects of product development
• Serve as clinical lead, providing medical expertise
• Partner with various teams to implement comprehensive clinical development plans
• Responsible for protocol design and medical monitoring
• Provide strategic and medical components of IND submissions
• Analyze clinical trial data, author publications
• Establish relationships with prominent leaders in cardiovascular disease
• Plan and conduct clinical advisory board meetings
• Present plans and results to senior leaders

Cytokinetics Jobs in New York City

Cytokinetics

Director, Regulatory Labeling

Cytokinetics

Associate Director, Regulatory Systems and Training

Cytokinetics

Medical Director, Clinical Research Cardiovascular

Cytokinetics