Senior PM Leader, Clinical & Regulatory Programs

Valid8 Financial, Inc.; Kentucky; Hybrid; USD 150,000 - 190,000; Full time

Benefits offered by this job

Competitive benefits

PTO

Stock options

Job summary

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

The role spans Clinical Development, Operations, Biometrics, Medical Affairs, and Regulatory, embedded in the PMO with matrix leadership. The ideal candidate has 7+ years in biotech program management, strong cross‑functional leadership, and SMartsheet proficiency, with a focus on risk management and

Qualifications

• 7+ years of program management in pharma/biotech with cell/gene therapy preferred.
• Experience supporting regulatory inspections in a GxP environment.
• Proficiency with Smartsheet and MS Office; strong communication skills.

Responsibilities

• Align program planning with corporate objectives and PDT strategy.
• Develop scope, timelines, budgets, and resource plans across the clinical portfolio.
• Lead cross-functional study teams and governance meetings.
• Prepare regulatory filings (INDs/BLAs) with collaborative partners.
• Deliver project updates to senior management with dashboards and reports.

Skills

Program management

Cross-functional leadership

Smartsheet expertise

Vendor management

Education

Advanced degree in Life Sciences (PhD/MS)

PM certification (PMP/CAPM)

Tools

MS Office

Smartsheet

Job description

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

The role spans Clinical Development, Operations, Biometrics, Medical Affairs, and Regulatory, embedded in the PMO with matrix leadership. The ideal candidate has 7+ years in biotech program management, strong cross‑functional leadership, and SMartsheet proficiency, with a focus on risk management and