Associate Director, Clinical Program Management (Remote)

Cabaletta Bio, Inc.; Kentucky; Remote; USD 150,000 - 210,000; Full time

Benefits offered by this job

Stock options

PTO

Job summary

Cabaletta Bio is seeking an Associate Director/ Sr. Manager, Program Management – Clinical, Medical & Regulatory to lead strategic planning and execution of autologous cell therapy programs.

The role integrates Clinical Development, Regulatory, Medical Affairs, and PMO activities while coordinating with cross-functional teams across time zones. The ideal candidate has 7+ years in program management within biotech or cell/gene therapy, with strong leadership, risk management, and Smartsheet

Qualifications

• 7+ years of program management experience in biotech or cell/gene therapy.
• Experience supporting regulatory filings (INDs/BLAs) and inspections is required.
• Strong cross-functional leadership and PMO best-practice knowledge.

Responsibilities

• Lead planning, execution, and delivery of clinical programs across Clinical Development, Clinical Operations, Biometrics, Medical Affairs, and Regulatory functions.
• Develop and maintain project plans, timelines, budgets, and resource plans; manage risk and contingencies.
• Oversee CROs, vendors, and external partners with contracts and performance management.
• Prepare project updates for senior management and coordinate with Finance and Legal for milestones.
• Promote enterprise PMO practices and train teams on Smartsheet usage.

Skills

Program management

Cross-functional leadership

Smartsheet

Regulatory filings

GxP

Vendor management

Communication

Education

Advanced degree in Life Sciences

Tools

Smartsheet

MS Office

Job description

Cabaletta Bio is seeking an Associate Director/ Sr. Manager, Program Management – Clinical, Medical & Regulatory to lead strategic planning and execution of autologous cell therapy programs.

The role integrates Clinical Development, Regulatory, Medical Affairs, and PMO activities while coordinating with cross-functional teams across time zones. The ideal candidate has 7+ years in program management within biotech or cell/gene therapy, with strong leadership, risk management, and Smartsheet