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 Leadership 

• Support preparation of regulatory submissions and health authority interactions. 

• Contribute clinical input into briefing books, responses to regulatory questions, and inspection readiness activities. 

• Collaborate with Regulatory Affairs, Clinical Pharmacology, Translational Medicine, Biometrics, and Commercial colleagues to support integrated product development. 

• Present clinical updates and recommendations to internal governance committees and senior leadership. 

Qualifications

• MD, DO, or equivalent medical degree. 

• A minimum of 3+ years industry clinical development experience.  

• Board certification or training in Oncology, Hematology/Oncology, Internal Medicine, or a related specialty. 

• Experience serving as a Medical Monitor for interventional clinical trials. 

• Working knowledge of GCP, ICH guidelines, and global regulatory requirements. 

• Strong understanding of oncology drug development and clinical trial conduct. 

• Excellent communication, collaboration, and problem-solving skills. 

Knowledge and Skills

• Experience supporting Phase 2 and/or Phase 3 oncology studies. 

• Experience with rare diseases, sarcomas, or desmoid tumors. 

• Experience supporting regulatory submissions and health authority interactions. 

• Experience working within a matrixed, cross-functional environment. 

• Demonstrated ability to interpret complex clinical and safety data and translate findings into development recommendations.