Director, TMF Operations & Inspection Readiness

Cytokinetics, Inc.; South San Francisco (CA); Hybrid; USD 187,000 - 218,000; Full time

Benefits offered by this job

Stock options

401k with employer match

Health, dental, vision, life insurance

Job summary

Cytokinetics, Inc. is seeking a Director of TMF Operations to lead our TMF transformation and ongoing operations. You will drive a governance framework, risk-based oversight, and inspection readiness across studies and CROs.

Collaborating with Clinical Operations, Quality/Compliance, Regulatory, and IT, you will implement KPI dashboards, harmonize TMF definitions, and embed TMF processes into core clinical workflows, enabling sponsor oversight and timely submissions.

Qualifications

• 6–8 years of clinical research experience with TMF leadership.
• Experience building TMF frameworks in outsourced or hybrid models.
• Proven ability to lead cross-functional, regulator-facing initiatives.

Responsibilities

• Lead TMF operating model, governance, and KPIs across studies and vendors.
• Drive TMF health metrics, risk indicators, and escalation pathways.
• Oversee TMF in outsourced models and sponsor oversight activities.
• Support TMF-related inspections and QA audits.
• Define eTMF strategy, governance, and validation efforts.

Skills

TMF leadership

CRO/vendor management

Strategic thinking

Cross-functional leadership

Regulatory communication

Education

BS/BA degree

Advanced degree

Tools

Veeva Vault TMF

Job description

Cytokinetics, Inc. is seeking a Director of TMF Operations to lead our TMF transformation and ongoing operations. You will drive a governance framework, risk-based oversight, and inspection readiness across studies and CROs.

Collaborating with Clinical Operations, Quality/Compliance, Regulatory, and IT, you will implement KPI dashboards, harmonize TMF definitions, and embed TMF processes into core clinical workflows, enabling sponsor oversight and timely submissions.