Medical Director, Medical Safety and Clinical Development - Remote

Overview

The Medical Director, Medical Safety and Clinical Development 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

• Contribute to the development and execution of comprehensive clinical development plans.
• Serve as a medical expert, staying current with the latest research.
• Design and oversee clinical trials, ensuring compliance with regulations.
• Collaborate with regulatory teams on submissions to health authorities.
• Provide medical oversight for clinical trials, including safety monitoring.
• Build relationships with key opinion leaders and academic institutions.
• Collaborate with various departments to align on program objectives.
• Lead the development of scientific publications and presentations.
• Support start-up activities related to clinical studies.
• Interface with international regulatory authorities as needed.

Requirements

• M.D./DO or equivalent with rare disease, pediatric, or neuroscience experience preferred.
• Board certification in a specialty is highly desired.
• 5+ years’ experience as a medical monitor in the pharmaceutical industry.
• Experience in early-stage development programs.
• Strong understanding of FDA, MHRA, and ICH GCP guidelines.
• Excellent oral and written communication skills.
• Experience designing mid- and late-phase clinical trials.
• Knowledge of biostatistics and clinical study design.

Benefits

• Confidentiality of information according to EEO guidelines.