Logo
Kolon TissueGene, Inc.

Medical Affairs Lead

Kolon TissueGene, Inc., Rockville, Maryland, us, 20849

Save Job

HR Business Leader- Analytics driven, Creating future-ready workplace ecosystems ✨

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

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.

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Disability insurance

Ready to shape medical strategy for a first-in-class cell therapy?

Apply now and help define the future of regenerative medicine.

Seniority level Director

Employment type Full-time

Job function Product Management

#J-18808-Ljbffr