- Remote, United States +1 more
- Remote
- Full-time · Manager
- $187K–$218K per year
- 6–8 years
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