Associate Director, TMF Operations

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🔥 0 minutes ago

🏄 California, Pennsylvania – Remote

🏄 California – Remote 🔔 Pennsylvania – Remote

💵 $172.8k - $217.9k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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Cytokinetics

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 1998

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 $450M Post-IPO Debt on 2022-06

Healthcare • Consulting • Manufacturing

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.

📋 Description

• Lead Cytokinetics TMF transformation and ongoing TMF operations to deliver a governed, inspection-ready TMF operating model • Drive TMF strategy, quality, oversight, governance, inspection readiness, and harmonized Sponsor TMF definition across systems and partners • Define and implement TMF processes, standards, KPIs, health metrics, risk indicators, and escalation pathways • Oversee TMF across all programs and ensure alignment with ICH-GCP, the TMF Reference Model, and global regulatory expectations • Lead TMF oversight in an outsourced model and drive CRO/vendor accountability for completeness, quality, and timeliness • Serve as TMF subject matter expert, guide cross-functional teams, support role-based training, and monitor adoption • Lead and support TMF activities for FDA, EMA, and other health authority inspections and QA audits • Drive inspection preparation, SME briefing, document retrieval, response coordination, evidence packages, remediation planning, and CAPA development • Drive eTMF system strategy and governance, including configuration, taxonomy, metadata standards, artifact mapping, reconciliation, vendor/system optimization, validation, change control, enhancements, releases, and UAT • Establish QC/QR frameworks and oversight models; drive TMF reconciliation and continuous improvement • Provide leadership and oversight to TMF staff and/or vendors, including mentoring and capability building • Partner with Clinical Operations, Study Teams, QA, Regulatory, IT, Procurement/Legal, and external partners • Lead or support TMF risk management, migrations, system implementations, vendor transitions, and contract/SOW requirements

🎯 Requirements

• BS/BA degree required; advanced degree highly desirable • 6-8 years of clinical research experience, including significant TMF/eTMF leadership experience for Associate Director level • Proven experience in building and leading TMF frameworks in an outsourced or hybrid operating model • Deep expertise in TMF strategy, governance, inspection readiness, and health authority inspections (FDA, EMA) • Strong knowledge of ICH-GCP, TMF Reference Model, and global regulatory requirements • Extensive experience with eTMF systems (e.g., Veeva Vault TMF or equivalent), including system governance and optimization • Experience managing CROs/vendors and holding them accountable for TMF quality and delivery • Excellent communication and ability to represent TMF in regulatory-facing settings • Demonstrated excellence in complex project management and effective management of multiple projects/priorities • Must have demonstrated ability to solve problems with innovative solutions along with strong organizational skills • Demonstrated ability to lead cross-functional initiatives and influence at a senior level • Strong leadership, strategic thinking, and decision-making skills

🏖️ Benefits

• Equity in the form of stock options and/or restricted stock units • Comprehensive health, dental, vision, life and disability insurance coverage • 401k retirement benefits with employer match • Learning and wellness stipends • Paid time off • Domestic travel required (up to 10%)

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