Director of Clinical Development

Job Summary

Leading the scientific design and clinical oversight of global Phase 3 trials, the full-time Director of Clinical Development will ensure high scientific rigor in pivotal clinical trials to support NDA and BLA submissions while working remotely.

Key responsibilities

• Oversee the scientific design of global Phase 3 trials and collaborate with cross-functional teams to maintain project timelines
• Develop clinical data collection and monitoring strategies, actively participate in data review, and synthesize study observations into recommendations for leadership
• Draft and manage responses to health authority inquiries and contribute to the development of clinical study reports and Investigator Brochures

Required qualifications

• PhD, PharmD, or equivalent scientific doctorate preferred, with relevant post-doctoral experience considered
• 8-10 years of experience in research and development, specifically managing global Phase 3 studies
• Demonstrated experience in clinical trial design and knowledge of GCP and ICH guidelines
• Experience in Immunology and Inflammation, particularly in atopic dermatitis or alopecia areata, is a plus
• Strong matrix leadership skills with the ability to influence cross-functional teams