Associate Director, TMF Operations

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

• Spearhead the transformation of Cytokinetics' TMF and manage ongoing TMF operations to establish a governed, inspection-ready TMF operating model.

• Cultivate TMF strategy, quality, oversight, governance, inspection readiness, and a unified Sponsor TMF definition across various systems and partners.

• Develop and execute TMF processes, standards, KPIs, health metrics, risk indicators, and escalation pathways.

• Supervise TMF across all programs, ensuring compliance with ICH-GCP, the TMF Reference Model, and global regulatory requirements.

• Direct TMF oversight in an outsourced model and enforce CRO/vendor accountability for completeness, quality, and timeliness.

• Act as the TMF subject matter expert, guiding cross-functional teams, supporting role-specific training, and monitoring implementation.

• Lead and support TMF activities for inspections and QA audits by the FDA, EMA, and other health authorities.

• Manage inspection preparations, subject matter expert briefings, document retrieval, response coordination, evidence packages, remediation planning, and CAPA development.

• Propel the eTMF system strategy and governance, including configuration, taxonomy, metadata standards, artifact mapping, reconciliation, vendor/system optimization, validation, change control, enhancements, releases, and user acceptance testing (UAT).

• Establish quality control/quality review frameworks and oversight models; drive TMF reconciliation and continuous enhancement.

• Provide leadership and guidance to TMF staff and/or vendors, emphasizing mentoring and capability development.

• Collaborate with Clinical Operations, Study Teams, QA, Regulatory, IT, Procurement/Legal, and external partners.

• Lead or assist with TMF risk management, migrations, system implementations, vendor transitions, and contract/SOW requirements.

⛳️ Requirements

• A BS/BA degree is required; an advanced degree is highly preferred.

• 6-8 years of experience in clinical research, including substantial TMF/eTMF leadership experience suitable for the Associate Director level.

• Demonstrated experience in establishing and guiding TMF frameworks within an outsourced or hybrid operational model.

• In-depth knowledge of TMF strategy, governance, inspection readiness, and health authority inspections (FDA, EMA).

• Strong understanding of ICH-GCP, TMF Reference Model, and global regulatory standards.

• Extensive familiarity with eTMF systems (e.g., Veeva Vault TMF or similar), including system governance and optimization.

• Proven experience in managing CROs/vendors and ensuring accountability for TMF quality and delivery.

• Outstanding communication skills and the ability to represent TMF in regulatory-facing environments.

• Demonstrated excellence in complex project management and effectively managing multiple projects and priorities.

• Must possess a proven ability to devise innovative solutions to problems, along with strong organizational capabilities.

• Demonstrated capability to lead cross-functional initiatives and exert influence at a senior level.

• Strong leadership, strategic thinking, and decision-making abilities.

🏝️ 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%).