TMF Operations Director: Strategy & Inspection Readiness

Cytokinetics; San Francisco (CA); Remote; USD 187,000 - 218,000; Full time

Benefits offered by this job

Equity (stock options/RSUs)

Health, dental, vision, life and disa​

401(k) with employer match

Learning stipend

Wellness stipend

Paid time off

Job summary

Cytokinetics is seeking a Director of TMF Operations to lead transformation and ongoing TMF governance for inspection-ready processes across studies and vendors. The role partners with Clinical Operations, Quality/Compliance, Regulatory, IT, and Procurement to embed TMF into core clinical processes.

You will drive risk-based oversight, KPIs, and dashboards, while managing CROs and ensuring compliance with ICH-GCP and TMF Reference Model.

Qualifications

• Bachelor-level degree required; advanced degree highly desirable.
• Significant TMF/eTMF leadership experience for Associate Director level.
• Deep expertise in TMF strategy, governance, inspection readiness, and health authority inspections (FDA/EMA).
• Extensive experience with eTMF systems and vendor management.

Responsibilities

• Lead the TMF operating model: strategy, governance, standards and operating model.
• Define TMF processes, KPIs, and risk-based oversight for consistency and compliance.
• Oversee TMF across programs ensuring alignment with ICH-GCP and TMF Reference Model.
• Lead TMF oversight in outsourced models; drive CRO/vendor accountability and dashboards.
• Establish health metrics, risk indicators, and escalation pathways across studies.
• Act as TMF SME, guide cross-functional teams, and support sponsor/CRO training.
• Lead TMF-related inspections readiness and responses (FDA/EMA) and QA audits.
• Drive TMF system strategy and governance across eTMF/CTMS/eDC/regulatory/QMS.
• Lead or support migrations, system implementations, and vendor transitions.

Skills

TMF leadership

Regulatory inspections

Cross-functional leadership

CRO/vendor management

Project management

ICH-GCP knowledge

eTMF systems

Veeva Vault TMF

Education

BS/BA degree

Advanced degree

Tools

Veeva Vault TMF

Job description

Cytokinetics is seeking a Director of TMF Operations to lead transformation and ongoing TMF governance for inspection-ready processes across studies and vendors. The role partners with Clinical Operations, Quality/Compliance, Regulatory, IT, and Procurement to embed TMF into core clinical processes.

You will drive risk-based oversight, KPIs, and dashboards, while managing CROs and ensuring compliance with ICH-GCP and TMF Reference Model.