Sr. Medical Director, Gastroenterology

Role Summary

We are seeking a Sr. Medical Director to lead the EoE (eosinophilic esophagitis) clinical development program. In this newly created role, you will serve as the EoE subject matter expert, overseeing clinical execution and medical monitoring of EoE studies. You will be responsible for seamless execution of trials and supporting the cross-functional development team in forming the clinical strategy with a focus on protocol development and execution, and medical monitoring activities. If you thrive in a fast-paced environment and seek the opportunity to advance new clinical programs into later stages of development, this role is for you!

Key Responsibilities

• Participate in the design and execution of clinical studies in a new therapeutic area (Gastroenterology)
• Contribute clinical and strategic perspective to EoE development program through BLA
• Serve as a medical monitor, working closely with the CRO, clinical operations, and pharmacovigilance on study execution, including but not limited to safety reporting, point of escalation for medical monitoring matters, development and execution of the Medical Monitoring Plan
• Contribute to the design of trials, and develop protocols and other relevant documents for individual studies
• Lead study start-up activities
• Direct day-to-day clinical and medical execution of studies
• Work closely with cross-functional colleagues, including, but not limited to, clinical operations, regulatory, biostatistics, and data management, to ensure timely and flawless execution of clinical plan
• Partner with clinical operations on site selection, recruitment, and CRO management
• Partner with medical affairs to build and maintain strong relationships with PIs, including support of Advisory and Scientific Boards and Investigator Meetings
• Serve as primary medical point of contact for sites and PIs for the assigned study, as applicable

Ideal Candidate

• Education – MD is required
• Board certification in Gastroenterology a plus (not required)