Clinical Development Director

Job Summary

Leading clinical studies for first-in-class oral medicines, the full-time Clinical Development Director will write protocols, manage studies end-to-end, and collaborate with cross-functional teams in a remote setting.

Key responsibilities

• Own studies from protocol development through start-up and enrollment
• Write protocols and clinical sections of regulatory documents, providing recommendations to the Global Program Head
• Collaborate with Clinical Operations to ensure adherence to timelines, enrollment targets, and data quality

Required qualifications

• An advanced degree (MD, DO, PhD, PharmD, or equivalent)
• Hands-on clinical development experience with a proven track record of leading studies from protocol to database lock (typically 8+ years for clinical scientists or 3+ years for physicians post-training)
• Clinical or trial experience in inflammatory bowel disease, preferably with endoscopic endpoints
• Experience in a second therapeutic area
• Data-driven judgment with the ability to make decisions based on clinical, safety, and operational data