Program Manager, Strategic Planning

About Us

Kolon TissueGene, Inc. (KTG) is a clinical‑stage cell therapy company headquartered in Rockville, Maryland. We are dedicated to developing transformative biological therapies for patients suffering from degenerative joint diseases—conditions that affect tens of millions of people worldwide and have few disease‑modifying treatment options.

Our lead program, TG‑C, is a gene‑mediated cell therapy designed to address knee osteoarthritis at its biological root. TG‑C is advancing toward Biologics License Application (BLA) submission to the FDA, the most consequential regulatory milestone for a biologic therapy. In parallel, KTG is expanding its clinical pipeline into additional indications, including degenerative disc disease (DDD), while building the commercial infrastructure required to support TG‑C upon approval.

KTG is operating at full pace across every function, with fixed external timelines and high executional demands. At this critical inflection point, coordination, visibility, and disciplined execution are paramount.

About the Role

We are seeking a Program Manager to join our Strategic Planning team, KTG’s operational backbone. This manager‑level individual contributor will drive accountability across priority initiatives and ensure alignment across regulatory, quality, clinical, and commercial readiness efforts. The role is responsible for maintaining integrated project plans, milestone trackers, risk logs, and executive‑level reporting that leadership depends on for decision‑making.

The ideal candidate is someone who can hold complexity together—tracking milestones, anticipating and surfacing risks, aligning stakeholders, and providing leadership with the clarity and confidence needed to move quickly and decisively.

What You Will Do

• Maintain and update program timelines, milestone trackers, risk logs, and action item registers for assigned workstreams
• Lead cross-functional follow-up to collect updates, confirm status, and resolve delays or gaps proactively
• Own commercial-related tracking and SP-side follow-up, ensuring readiness items and dependencies are clearly reflected in management materials
• Prepare and deliver recurring executive reports, including monthly program updates and management review packages
• Manage version control, comment resolution, and on-time submission of reporting materials
• Improve trackers, templates, and reporting flows to reduce rework and increase standardization
• Prepare meeting agendas, capture minutes, and maintain organized records across all assigned programs
• Support additional strategic planning and governance activities, including high-priority executive follow-up items

What You Bring

• Bachelor’s degree in Business, Life Sciences, Engineering, Project Management, or a related field required
• 5+ years of experience in program management, PMO, strategic planning support, or cross-functional operations required
• Background in biotech, pharma, healthcare, or another regulated environment required
• Proven experience managing timelines, trackers, and recurring executive-level reporting materials
• Experience supporting commercial-related planning, reporting, or cross-functional follow-up
• Strong Excel and PowerPoint skills; familiarity with MS Project or similar tools

If you’re someone who thrives at the center of complex, high‑stakes programs—and wants to make a real impact at a pivotal moment—we’d love to hear from you.

Work Environment

• Full-time, onsite position with standard office hours
• Occasional early morning or evening availability may be needed for urgent reporting cycles or cross-time-zone meetings
• Extensive computer and keyboard use involving repetitive motion.
• Regular telephone and in-person communication.
• Ability to lift up to 25 pounds, with or without reasonable accommodation.

Benefits Highlights:

• Premium-free global health insurance (50% dependent coverage)
• 401(k) with immediate eligibility
• On-site gym & wellness perks
• Extra PTO accrual every year
• Global and local training opportunities

Equal Opportunity Employer

Kolon TissueGene, Inc. is proud to be an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration without regard to race, color, religion, gender, identity, sexual orientation, national origin, disability, or veteran status.

Apply today to shape the future of regenerative medicine with precision, rigor, and purpose.

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