Medical Director, Clinical Development - Remote

Overview

The Medical Director will play a key role on cross-functional teams responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted for the clinical development programs.

In Short

• Lead clinical development plans and studies.
• Provide CRO oversight and safety monitoring.
• Collaborate on clinical trial strategy and design.
• Serve as a medical expert within the company.
• Prepare and submit regulatory documents.
• Engage with key opinion leaders and institutions.
• Develop scientific publications and educational materials.
• Support start-up activities for clinical studies.
• Interface with international regulatory authorities.
• Ensure compliance with regulatory standards.

Requirements

• M.D./DO or equivalent with rare disease experience preferred.
• 5+ years’ experience as a medical monitor.
• Experience in early-stage development programs.
• Strong communication and interpersonal skills.
• Proficiency in clinical/medical writing.
• Knowledge of biostatistics and clinical study design.
• Ability to analyze research data.
• Experience with FDA and ICH GCP guidelines.
• Ability to work collaboratively in a team.
• Experience designing mid- and late-phase clinical trials.

Benefits

• Opportunity to impact rare disease treatment.
• Collaborative work environment.
• Engagement with leading experts in the field.
• Remote work flexibility.
• Continued professional development opportunities.