Senior Program Manager, Clinical Operations & Regulatory

Cabaletta Bio; Philadelphia, Northern (Philadelphia County, KY); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Health and retirement benefits

Paid time off (PTO)

Stock option plan

Job summary

Cabaletta Bio in Philadelphia is seeking a Sr. Manager / Associate Director of Program Management – Clinical, Medical & Regulatory to lead strategic planning and execution across Clinical Development, Operations, Biometrics, Medical Affairs, and Regulatory functions.

This embedded PMO role will ensure robust, risk-managed program plans aligned with asset timelines and corporate objectives. The ideal candidate has 7+ years (Sr.

Qualifications

• Experience in pharmaceutical or biotechnology industries is required.
• 7+ years of program management experience is required for Sr. Manager level; 8+ years for Associate Director level.
• Direct experience supporting regulatory Health Authority Inspections in a GxP-regulated environment is required.
• Extensive Smartsheet experience, including creating, maintaining, and reporting timelines, Gantt charts, dashboards, and reports.

Responsibilities

• Work with the CMR portfolio PM and lead Asset PM to align program planning and execution with corporate objectives and PDT strategy.
• Develop project scope, timelines, budgets, and resource plans across the clinical portfolio.
• Lead cross-functional study team and governance meetings, including agendas, decision logs, minutes, action-item tracking, collaboration, and team alignment.
• Partner with Clinical Operations, Clinical Development, Biometrics, Medical Affairs, and Regulatory leaders to develop and maintain project plans, timelines, and dashboards for multiple clinical programs.
• Identify, score, and communicate risks through maintained risk registers with proactive mitigation and contingency plans; ensure department timelines and risk trackers integrate with the corporate portfolio and integrated roadmaps.
• Manage CROs, vendors, and external partners by tracking performance and contracts, escalating and resolving issues, leading vendor governance meetings, and cultivating durable relationships focused on on-time, quality delivery.
• Support preparation and submission of regulatory filings, including INDs and BLAs, in partnership with Clinical, Regulatory Affairs, Technical Development, and Supply Chain.
• Prepare and present project updates to senior management and key stakeholders to support decision-making; partner with Finance and Legal to facilitate on-time, on-budget milestone delivery.

Skills

Program management

Cross-functional leadership

Smartsheet

Vendor management

Education

Advanced degree in Life Sciences

PMP or CAPM certification

Tools

MS Office

Project management tools

Job description

Cabaletta Bio in Philadelphia is seeking a Sr. Manager / Associate Director of Program Management – Clinical, Medical & Regulatory to lead strategic planning and execution across Clinical Development, Operations, Biometrics, Medical Affairs, and Regulatory functions.

This embedded PMO role will ensure robust, risk-managed program plans aligned with asset timelines and corporate objectives. The ideal candidate has 7+ years (Sr.