Medical Director / Senior Medical Director, Clinical Development

Position Overview

We are seeking a highly motivated physician to serve as Medical Monitor for the late-stage development of varegacestat, an investigational therapy being developed for desmoid tumors. This individual will provide medical oversight for global clinical studies and serve as a key member of the Clinical Development team, partnering closely with Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, Medical Writing, and Translational Medicine. 

The Medical Monitor will be responsible for patient safety oversight, protocol implementation, investigator engagement, medical review of efficacy and safety data, and contribution to regulatory interactions. This position offers an opportunity to play a significant role in the registration and global development strategy of a potentially first-in-class therapy addressing a significant unmet medical need. 

Responsibilities

Medical Monitoring and Patient Safety 

• Serve as the primary Medical Monitor for global clinical studies. 

• Provide ongoing medical review of safety, efficacy, and eligibility data. 

• Evaluate and assess serious adverse events (SAEs), adverse events of special interest (AESIs), and emerging safety signals. 

• Collaborate with Pharmacovigilance to ensure timely safety assessment, signal detection, and risk management activities. 

• Participate in Safety Review Committees, Data Monitoring Committees, and other governance forums as needed. 

• Ensure subject safety remains the primary consideration in study conduct and decision-making. 

Clinical Trial Conduct 

• Provide medical oversight of study execution from initiation through database lock and study reporting. 

• Support protocol development, protocol amendments, informed consent forms, and study-related documents. 

• Review protocol deviations, eligibility questions, endpoint assessments, and other medically relevant study issues. 

• Partner with Clinical Operations to address site-level medical questions and enrollment challenges. 

• Assist with development and maintenance of study training materials. 

Investigator and External Engagement 

• Serve as a primary medical contact for investigators and study sites. 

• Participate in investigator meetings, site initiation visits, and key study governance meetings. 

• Support interactions with key opinion leaders and external experts. 

• Contribute to advisory boards and scientific discussions relevant to the development program. 

Data Review and Interpretation 

• Conduct ongoing review of accumulating safety and efficacy data. 

• Collaborate with Clinical Scientists and Biostatistics to identify trends, data quality issues, and emerging clinical insights. 

• Participate in blinded and unblinded data review activities as appropriate. 

• Contribute to interpretation of study results and preparation of clinical study reports, publications, and scientific presentations. 

Regulatory and Cross-Functional Leaders