Senior Manager, Program Management – Clinical, Medical & Regulatory

Cabaletta Bio

. Lead strategic planning, execution, and delivery of clinical programs across Clinical Development, Clinical Operations, Biometrics, Medical Affairs, and Regulatory .

Posted 9/19/2026full-timePhiladelphia • Pennsylvania • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading clinical program management, including strategic planning, execution, and delivery across various clinical functions. Proficient in managing vendor relationships, regulatory filings, and utilizing project management tools to ensure on-time and on-budget project milestones.

Highest-signal resume keywords

Program Management ExperienceRegulatory Health Authority InspectionsSmartsheet ProficiencyProject Management CertificationPharmaceutical Industry Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Project Scope DevelopmentRisk ManagementBudget ManagementTimeline ManagementClinical Program DeliveryGxP ComplianceVendor ManagementClinical Program PlanningCross-Functional Team LeadershipRegulatory Filing Support

Soft Skills

Strong Communication SkillsAttention to DetailAbility to Manage Multiple TasksIndependent and Collaborative Work

Tools & Technologies

MS Office SuiteSmartsheetProject Management Tools

Certifications & Qualifications

PMP CertificationCAPM Certification

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryClinical DevelopmentCell and Gene TherapyCAR-T TherapyGxP-Regulated Environment

Tech Stack

Tools & technologies

PMP

About the role

Key responsibilities & impact

Lead strategic planning, execution, and delivery of clinical programs across Clinical Development, Clinical Operations, Biometrics, Medical Affairs, and Regulatory
Align program planning and execution with corporate objectives and Product Development Team 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, and action tracking
Maintain project plans, timelines, and dashboards for multiple clinical programs
Identify, score, communicate, and mitigate program risks using risk registers and contingency plans
Manage CROs, vendors, and external partners, including performance, contracts, governance, and issue resolution
Support regulatory filings, including INDs and BLAs
Prepare and present project updates to senior management and stakeholders
Partner with Finance and Legal to facilitate on-time, on-budget milestone delivery
Advance PMO best practices through scalable tools, templates, and processes
Serve as Smartsheet Super User by building plans, dashboards, and reports and training team members
Work across time zones; travel 10–15% may be required

Requirements

What you’ll need

Experience in pharmaceutical or biotechnology industries is required
7+ years of program management experience for Sr. Manager level; 8+ years for Associate Director level
Direct experience supporting regulatory Health Authority Inspections in a GxP-regulated environment is required
Proficiency in MS Office, including Outlook, PowerPoint, Excel, and Word
Familiarity with project management tools
Strong understanding of PM best practices, PMO operating models, and scalable processes
Extensive Smartsheet experience, including timelines, Gantt charts, dashboards, and reports
Experience managing vendor relationships and contracts
Strong verbal and written communication skills
Outstanding attention to detail and ability to manage multiple tasks and priorities
Ability to work independently and collaboratively with cross-functional teams
Experience in cell and gene therapy, CAR-T, or similar industry preferred
Advanced degree in Life Sciences preferred
Project management certification such as PMP or CAPM preferred
Experience with early- and late-stage clinical programs advantageous

Benefits

Comp & perks

Competitive benefits
PTO
Stock option plans
Commitment to employee well-being and continuous growth
Great Place to Work-Certified™ company