Search the 9 jobs at Cytokinetics

Oversee daily TMF management operations, ensuring inspection readiness and compliance with Cytokinetics policies. Responsibilities include document quality control, TMF record submission, risk mitigation, and collaboration with study teams and external partners. Stay updated on regulatory requirements and support inspection preparations.

The Head of Commercial Legal will provide legal advice and support to the Commercial and Medical Affairs teams, ensuring compliance with healthcare regulations, managing contracts, and overseeing legal and compliance initiatives. The role involves mentoring a legal team and collaborating closely with corporate leadership, while also monitoring legal developments affecting the business.

The Head of Legal and Compliance will provide legal advice to the Commercial and Medical Affairs teams, establish compliance culture, negotiate agreements for medication commercialization, and implement compliance programs in Europe. The role involves advising on healthcare regulations and requires significant experience in biotechnology law.

The Senior TMF Specialist at Cytokinetics will oversee the management and quality control of Trial Master File documentation, ensuring compliance with regulations and providing guidance to study teams. Responsibilities include managing TMF documentation in Veeva Vault, conducting TMF reviews, and mentoring TMF specialists while collaborating with cross-functional teams for inspection readiness and process improvement.

The Contract Senior Study Start-Up Specialist oversees and leads all start-up activities for assigned clinical studies, ensuring compliance with regulations and internal procedures. Responsibilities include preparing necessary documentation for ethics and regulatory approvals, maintaining study start-up metrics, guiding Clinical Trial Managers, and supporting patient recruitment efforts. They also negotiate study budgets and contracts while continuously seeking improvements in the start-up process.

The Global HCM Therapeutic Lead will guide Medical Affairs for the aficamten product launch, manage clinical and medical input, collaborate cross-functionally with Commercial and Clinical teams, expand KOL networks, and lead publication strategies in the HCM space.

Cytokinetics is seeking passionate individuals to join its Talent Community for various potential roles. The company focuses on innovative medicines for cardiovascular and neuromuscular diseases, promoting a culture of integrity and scientific excellence. The Talent Community offers a way to connect and learn about opportunities at Cytokinetics.

The role involves designing and developing scalable AI applications, integrating large language models, ensuring security, and optimizing backend services using Python. Collaboration with various teams to innovate AI solutions and manage complex tasks is key, along with creating robust software for LLM interactions and addressing security risks.

Provide comprehensive executive-level administrative support to the CEO, manage confidential information, coordinate meetings and travel, prepare presentations, lead special projects, and maintain office operations efficiently.