Sr. Manager or Associate Director, Program Management – Clinical, Medical & Regulatory
Cabaletta Bio
August 24, 2026
Remote friendly (All, MO)
United States
Operations
Responsibilities:
- Align clinical 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 teams and governance meetings (agendas, decision logs, minutes, action-item tracking).
- Partner with Clinical Operations, Clinical Development, Biometrics, Medical Affairs, and Regulatory to develop/maintain project plans, timelines, and dashboards.
- Maintain and communicate risks via risk registers with proactive mitigation and contingency plans; integrate risk trackers with corporate roadmaps.
- Manage CROs, vendors, and external partners (track performance/contracts, escalate issues, lead governance meetings).
- Support preparation and submission of regulatory filings (INDs, BLAs).
- Prepare and present project updates to senior leadership; partner with Finance and Legal to deliver on-time, on-budget milestones.
- Advance PMO best practices using tools/templates to enable continuous improvement.
- Serve as Smartsheet Super User (build/publish plans, dashboards, reports; train team).
- Work across time zones; travel 10–15%.
Required Qualifications:
- 7+ years (Sr. Manager) or 8+ years (Associate Director) program management in biotech/cell & gene therapy clinical trials.
- Experience in pharmaceutical/biotechnology industries.
- Direct experience supporting regulatory Health Authority Inspections in a GxP environment.
- MS Office proficiency and familiarity with PM tools.
- Strong understanding of PM best practices/PMO operating models and scalable processes.
- Extensive Smartsheet experience (timelines, Gantt charts, dashboards, reporting).
- Vendor relationship/contract management experience.
- Strong verbal/written communication; attention to detail; multitasking.
- Ability to work independently and cross-functionally; thrive in fast-paced, timeline-based environments.
Preferred Qualifications:
- Advanced degree in Life Sciences.
- PMP/CAPM certification.
- Experience across early- and late-stage clinical programs.
- Cell & gene therapy/CAR-T (or similar) experience.
Application Instructions:
- Apply via Cabaletta’s “Join Our Crew” page: https://www.cabalettabio.com/join-our-crew
- Align clinical 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 teams and governance meetings (agendas, decision logs, minutes, action-item tracking).
- Partner with Clinical Operations, Clinical Development, Biometrics, Medical Affairs, and Regulatory to develop/maintain project plans, timelines, and dashboards.
- Maintain and communicate risks via risk registers with proactive mitigation and contingency plans; integrate risk trackers with corporate roadmaps.
- Manage CROs, vendors, and external partners (track performance/contracts, escalate issues, lead governance meetings).
- Support preparation and submission of regulatory filings (INDs, BLAs).
- Prepare and present project updates to senior leadership; partner with Finance and Legal to deliver on-time, on-budget milestones.
- Advance PMO best practices using tools/templates to enable continuous improvement.
- Serve as Smartsheet Super User (build/publish plans, dashboards, reports; train team).
- Work across time zones; travel 10–15%.
Required Qualifications:
- 7+ years (Sr. Manager) or 8+ years (Associate Director) program management in biotech/cell & gene therapy clinical trials.
- Experience in pharmaceutical/biotechnology industries.
- Direct experience supporting regulatory Health Authority Inspections in a GxP environment.
- MS Office proficiency and familiarity with PM tools.
- Strong understanding of PM best practices/PMO operating models and scalable processes.
- Extensive Smartsheet experience (timelines, Gantt charts, dashboards, reporting).
- Vendor relationship/contract management experience.
- Strong verbal/written communication; attention to detail; multitasking.
- Ability to work independently and cross-functionally; thrive in fast-paced, timeline-based environments.
Preferred Qualifications:
- Advanced degree in Life Sciences.
- PMP/CAPM certification.
- Experience across early- and late-stage clinical programs.
- Cell & gene therapy/CAR-T (or similar) experience.
Application Instructions:
- Apply via Cabaletta’s “Join Our Crew” page: https://www.cabalettabio.com/join-our-crew