What are the responsibilities and job description for the Medical Affairs Lead position at Kolon TissueGene, Inc.?
✨ About the Role
We are seeking a Medical Affairs Lead / Medical Director to provide senior medical and scientific leadership for TG-C, our first-in-class cell therapy for osteoarthritis and other degenerative diseases. Reporting directly to the Chief Medical Officer, this highly visible role serves as a strategic bridge between science, medicine, and executive leadership, while acting as the primary medical interface with the healthcare community.
This role is ideal for a proven scientific leader who thrives at the intersection of clinical insight, external engagement, and corporate strategy.
Key Responsibilities
🧬 Medical Affairs Strategy & Leadership
- Lead medical affairs strategy, planning, and execution for assigned therapeutic areas.
- Develop and execute medical plans including post-marketing research, medical education, grants, publications, and advisory boards.
- Translate complex scientific and clinical data into clear, compelling medical narratives.
External Scientific & KOL Engagement
- Identify, engage, and maintain relationships with key opinion leaders and external stakeholders.
- Represent the organization at scientific meetings, congresses, and advisory forums.
- Monitor scientific trends, treatment landscapes, and competitive activity to inform strategy.
Clinical & Evidence Generation Support
- Support clinical trial planning, real-world evidence generation, and post-marketing surveillance strategies.
- Collaborate on labeling strategy to ensure scientific accuracy, regulatory alignment, and product differentiation.
- Contribute to strategies for future label extensions.
Cross-Functional & Executive Collaboration
- Partner closely with Clinical, Regulatory, Commercial, and Market Access teams to integrate medical insights into corporate strategy.
- Advise senior leadership and C-suite executives with data-driven scientific recommendations.
People, Budget & Program Management
- Manage medical affairs resources, budgets, vendors, and timelines.
- Lead and develop talent through goal setting, performance management, and mentoring.
Qualifications
Education
- PhD, PharmD, MD, or equivalent doctoral degree (required)
Experience
- 12 years in pharma, biotech, or healthcare, including 5 years in Medical Affairs, scientific affairs, clinical, or strategy roles
- Experience in osteoarthritis or degenerative joint diseases strongly preferred
- Proven leadership in global clinical trials
- Strong working knowledge of FDA regulations and ICH guidelines
- Prior experience managing cross-functional teams, budgets, and external partners
Skills
- Executive-level communication and cross-functional influence
- Strategic and critical thinking with business agility
- Medical Affairs leadership and technical breadth
- Mentoring, resource planning, and program management
Leadership Competencies
- Strategic Influence & Executive Presence
- Scientific Integrity & Compliance
- Innovation and forward-thinking mindset
- Ability to translate medical insights into enterprise impact
Work Conditions
- Up to 50% travel
- Direct reporting line to C-suite leadership
About Us
Kolon TissueGene, Inc. is a Maryland-based biopharmaceutical company advancing regenerative medicine through innovative cell and gene therapies. Our lead asset, TG-C, is a clinical-stage cell therapy designed to reduce pain, improve function, and slow disease progression in osteoarthritis of the knee.
Equal Opportunity Employer
Kolon TissueGene, Inc. is an equal opportunity employer committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, national origin, disability, or veteran status.
Ready to shape medical strategy for a first-in-class cell therapy?
Apply now and help define the future of regenerative medicine.