Associate Director, 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 10/7/2026full-timeRemote • 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 submissions, and utilizing project management tools to ensure on-time and on-budget project milestones.

Highest-signal resume keywords

Program Management ExperienceRegulatory Health Authority InspectionsSmartsheet ProficiencyClinical Trial EnvironmentsProject Management Certification

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Program ManagementProject Scope DevelopmentRisk ManagementBudget ManagementTimeline DevelopmentGantt Chart CreationVendor ManagementRegulatory Submission PreparationClinical Program ExecutionCross-Functional Team Leadership

Soft Skills

Strong Communication SkillsAbility to Manage Multiple TasksCollaborative TeamworkIndependent Work Capability

Tools & Technologies

MS Office SuiteSmartsheetProject Management Tools

Certifications & Qualifications

PMP CertificationCAPM Certification

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryGxP-Regulated EnvironmentCell and Gene TherapyCAR-T

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-item tracking
Develop and maintain project plans, timelines, and dashboards for multiple clinical programs
Identify, score, and communicate risks through risk registers with mitigation and contingency plans
Manage CROs, vendors, and external partners, including performance, contracts, issue resolution, and vendor governance
Support preparation and submission of 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
Create and use PM tools and templates to advance enterprise PMO best practices
Serve as Smartsheet Super User by building and publishing plans, dashboards, and reports and training team members
Work across time zones as necessary; 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, and familiarity with project management tools
Strong understanding of PM best practices, PMO operating models, and scalable processes
Extensive Smartsheet experience, including creating, maintaining, and reporting timelines, Gantt charts, dashboards, and reports
Experience managing vendor relationships and contracts
Strong verbal and written communication skills
Ability to manage multiple tasks and priorities
Ability to work independently and collaboratively with cross-functional teams
Experience in clinical trial environments within biotech or cell and gene therapy
Advanced degree in Life Sciences is preferred
Certification in project management, such as PMP or CAPM, is preferred
Experience with early- and late-stage clinical programs is an advantage
Cell and gene therapy, CAR-T, or similar industry experience is preferred
Authorization to work in the United States is addressed in the application

Benefits

Comp & perks

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