Lead and oversee the TMF operating model, strategy, governance, and inspection readiness for Cytokinetics clinical programs.
Locations (2)
South San Francisco, California, United States
Radnor
Compensation
The salary range for this position is:
South San Francisco, California: $186,750-$217,875
Radnor: $172,800-$201,600
Responsibilities
Lead the TMF operating model, including strategy, governance, standards, and operating model to support portfolio
Define and implement TMF processes, standards, and KPIs to promote consistency, quality, and compliance across studies and vendors utilizing a risk-based approach to ensure sponsor oversight
Oversee TMF across all programs, ensuring alignment with ICH-GCP, TMF Reference Model, and global regulatory expectations
Lead TMF oversight in an outsourced model, driving CRO/vendor accountability for TMF completeness, quality, and timeliness, including dashboards and governance reporting to senior leadership
Establish and drive TMF health metrics, risk indicators, and escalation pathways across studies
