Associate Director, TMF Operations

Cytokinetics

. Lead Cytokinetics TMF transformation and ongoing TMF operations to deliver a governed, inspection-ready TMF operating model .

Posted 11/6/2026full-timeRemote • United StatesSenior💰 $172,800 - $217,875 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in TMF strategy, governance, and inspection readiness, with a strong focus on eTMF systems and regulatory compliance. Proven ability to lead cross-functional teams, manage CROs, and drive continuous improvement in TMF operations.

Highest-signal resume keywords

TMF StrategyETMF Systems ManagementICH-GCP ComplianceLeadership in Clinical ResearchProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

TMF Framework DevelopmentInspection ReadinessKPI DefinitionRisk ManagementTMF ReconciliationDocument RetrievalCAPA DevelopmentVendor AccountabilityHealth Authority InspectionsTMF Quality Oversight

Soft Skills

Excellent CommunicationStrategic ThinkingProblem SolvingOrganizational SkillsInfluencing Skills

Tools & Technologies

ETMF SystemsVeeva Vault TMFChange ControlUATMetadata Standards

Industry Keywords

Clinical ResearchTMF Reference ModelFDAEMARegulatory Compliance

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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%)