Senior Manager, Clinical Program Management — Remote

Valid8 Financial, Inc.; Kentucky; On-site; USD 140,000 - 190,000; Full time

Job summary

Cabaletta Bio seeks a Sr. Manager / Associate Director, Program Management – Clinical, Medical & Regulatory to lead strategic planning and delivery of autologous cell therapy programs.

This embedded PMO role collaborates with Clinical Development, Operations, Biometrics, Medical Affairs and Regulatory to ensure on-time, on-budget milestones. The ideal candidate has 7+ years in biotech/clinical PM, strong cross-functional leadership, and expertise in Smartsheet.

Qualifications

• 7+ years of program management experience in biotech or cell/gene therapy.
• Direct experience supporting regulatory Health Authority inspections in a GxP-regulated environment.
• Strong cross-functional leadership across Clinical Development, Clinical Operations, Biometrics, Medical Affairs, and Regulatory.
• Proficiency with Smartsheet for timelines, dashboards, and reports.
• Excellent written and verbal communication; vendor management experience.

Responsibilities

• Align program planning with CDPT strategy and PMO objectives.
• Develop scope, timelines, budgets, and resource plans for clinical programs.
• Lead cross-functional study teams and governance meetings.
• Maintain risk registers with proactive mitigation and contingency plans.
• Manage CROs, vendors, contracts, and vendor governance meetings.
• Support regulatory filings (INDs/BLAs) in partnership with Regulatory.
• Prepare project updates for senior management and stakeholders.
• Advance enterprise PMO best practices with PM tools/templates.
• Serve as Smartsheet Super User and train team members.
• Work across time zones; travel 10–15%.

Skills

Program management

Cross-functional leadership

Communication

Vendor management

Smartsheet

MS Office

Education

Advanced degree in Life Sciences

Tools

Smartsheet

MS Office

Job description

Cabaletta Bio seeks a Sr. Manager / Associate Director, Program Management – Clinical, Medical & Regulatory to lead strategic planning and delivery of autologous cell therapy programs.

This embedded PMO role collaborates with Clinical Development, Operations, Biometrics, Medical Affairs and Regulatory to ensure on-time, on-budget milestones. The ideal candidate has 7+ years in biotech/clinical PM, strong cross-functional leadership, and expertise in Smartsheet.