Overview

An early-stage biotech company is seeking an experienced Medical Director / Clinical Development Lead to provide strategic and operational leadership for a first-in-human Phase 1 clinical program focused on rheumatoid arthritis, with potential expansion into metabolic indications.

This part-time consulting role will lead clinical development strategy, regulatory activities, protocol design, and key opinion leader (KOL) engagement while helping shape future Phase 2 development.

Key Responsibilities

• Lead Phase 1 clinical development strategy and protocol design.
• Drive execution of first-in-human clinical studies.
• Build and maintain relationships with U.S. investigator sites and KOLs.
• Lead clinical components of regulatory submissions and health authority interactions.
• Partner with Clinical Operations, Regulatory, Translational Sciences, and Data Science teams.
• Support planning for Phase 2 clinical development.

Qualifications

• MD with significant clinical development experience in autoimmune diseases, preferably rheumatoid arthritis.
• Experience leading early-phase (Phase 1/2) clinical development programs.
• Strong network of U.S. investigators and key opinion leaders.
• Experience supporting regulatory submissions and cross-functional clinical development.
• Comfortable working in a fast-paced, early-stage biotech environment.
• Excellent leadership, communication, and collaboration skills.

Commitment

• Remote (U.S.)
• Approximately 20 hours per week
• Initial 6-month contract with strong potential for extension.

‍