About the Role

Kolon TissueGene, Inc. is seeking an
Associate Director, Bioinformatics
to provide hands-on technical and operational leadership supporting clinical development programs. This role is responsible for managing bioinformatics, biostatistics, and statistical programming activities that enable high-quality, compliant clinical data generation and analysis.

Reporting to the
Senior Director, Bioinformatics
, the Associate Director will lead a small team of bioinformatics professionals and collaborate cross-functionally with Clinical Operations, Medical Affairs, Regulatory, and external partners to align data strategies with organizational and regulatory objectives.

This position is based on-site at our Rockville, Maryland headquarters.

Key Responsibilities

Bioinformatics & Clinical Data Leadership

• Lead and deliver bioinformatics, biostatistics, and statistical programming activities for clinical studies.
• Support clinical trial design, data analysis, interpretation, and reporting.
• Participate in protocol development, including statistical analysis plans.
• Contribute to scientific publications, abstracts, and presentations.

Operational & Team Management

• Oversee day-to-day bioinformatics, data management, and statistical programming operations.
• Mentor, coach, and develop junior staff within the Bioinformatics function.
• Ensure timely, accurate, and high-quality deliverables aligned with clinical development timelines.

Cross-Functional & External Collaboration

• Partner with Clinical, Medical, Regulatory, and external vendors to support clinical development objectives.
• Assist with vendor oversight and coordination of external biometrics resources.
• Support regulatory submissions and participate in regulatory meetings as needed.

Compliance & Quality

• Ensure compliance with internal procedures, CDISC standards, and applicable regulatory requirements.
• Promote data integrity, documentation quality, and inspection readiness across all deliverables.

Qualifications

Education

• Master’s degree in Statistics, Biostatistics, Bioinformatics, or a related scientific discipline.

Experience

• Minimum of
  10 years of relevant experience
  in pharmaceutical, biotechnology, or clinical research environments.
• Demonstrated hands-on experience with clinical trial data analysis and reporting.
• Proficiency in SAS and other statistical or data science tools.
• Proven experience mentoring and developing junior professionals.

Core Competencies

• Strong technical expertise in bioinformatics and statistical methodologies.
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively in a multidisciplinary environment.
• Strong organizational, analytical, and problem-solving skills.
• Commitment to continuous learning and professional development.

Work Environment & Physical Requirements

• On-site position with up to
  approximately 20% travel
  .
• 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.

Kolon TissueGene will provide
reasonable accommodations
for qualified individuals with disabilities in accordance with the
Americans with Disabilities Act (ADA)
and applicable state law.

Why Join Kolon TissueGene?

Kolon TissueGene is advancing
innovative regenerative cell and gene therapies
designed to address the root causes of disease. As a member of our Bioinformatics team, you will contribute directly to the scientific rigor and data integrity that enable safe, effective therapies to reach patients.

About Us

Kolon TissueGene, Inc. (KTG)
is a clinical-stage biopharmaceutical company developing first-in-class regenerative therapies, including TG-C for osteoarthritis of the knee. We are building a mission-driven team committed to scientific excellence, regulatory compliance, and patient impact.

Equal Opportunity Employer

Kolon TissueGene, Inc. is an
Equal Opportunity Employer
. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin,