Cytokinetics
Biotechnology • Pharmaceuticals • Healthcare Insurance
Cytokinetics is a late-stage biopharmaceutical company that focuses on the discovery, development, and commercialization of potential medicines aimed at improving muscle function. The company is particularly active in developing treatments for cardiovascular and neuromuscular diseases, such as heart failure, hypertrophic cardiomyopathy, and other conditions of impaired muscle function. Cytokinetics has a robust pipeline of small molecule muscle activators and inhibitors and is committed to improving patients' lives through its scientific research and development efforts. The company's mission revolves around empowering muscle and thereby empowering lives, with patients being the central focus of its activities. Based in South San Francisco, Cytokinetics has been pioneering the field of muscle biology for over 25 years.
201 - 500 employees
Founded 1998
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
💰 $450M Post-IPO Debt on 2022-06
Contract – Trial Master File Manager
Job not on LinkedIn
October 15
🇺🇸 United States – Remote
💵 $65 - $80 / hour
⏳ Contract/Temporary
🟡 Mid-level
🟠 Senior
👔 Manager
🦅 H1B Visa Sponsor
Cytokinetics
Biotechnology • Pharmaceuticals • Healthcare Insurance
Cytokinetics is a late-stage biopharmaceutical company that focuses on the discovery, development, and commercialization of potential medicines aimed at improving muscle function. The company is particularly active in developing treatments for cardiovascular and neuromuscular diseases, such as heart failure, hypertrophic cardiomyopathy, and other conditions of impaired muscle function. Cytokinetics has a robust pipeline of small molecule muscle activators and inhibitors and is committed to improving patients' lives through its scientific research and development efforts. The company's mission revolves around empowering muscle and thereby empowering lives, with patients being the central focus of its activities. Based in South San Francisco, Cytokinetics has been pioneering the field of muscle biology for over 25 years.
201 - 500 employees
Founded 1998
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
💰 $450M Post-IPO Debt on 2022-06
📋 Description
• Lead day-to-day oversight and strategic management of study-specific TMFs • Drive adherence to Cytokinetics’ TMF SOPs, policies, and regulatory requirements • Support inspection preparation activities • Provide regular TMF status and compliance reports to the Study Lead and key stakeholders • Clarify functional document ownership and submission expectations
🎯 Requirements
• Bachelor’s Degree preferred • 5+ years’ experience managing or supporting TMF activities for clinical research/biotech/CRO company • 1+ years of experience serving as eTMF Administrator • Working knowledge of CDSIC Trial Master File Reference Model and ALCOA+ standard • Working knowledge of applicable FDA, Canadian, EU, and ICH guidelines
🏖️ Benefits
• Health insurance • 401(k) matching • Flexible working hours • Paid time off
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