Director, Medical Monitoring

Role: The Director, Medical Monitoring ensures medical oversight of clinical trials for Kiniksa's biopharma portfolio, focusing on safety review and study integrity in accordance with GCP. Responsibilities include real-time safety data assessment, acting as a medical contact for investigators, supporting study design and amendments, and collaborating with cross-functional teams like Safety, Regulatory, and Biostatistics. The role involves oversight of Phase 2-3 trials, safety signal detection, and contributing to regulatory documents and safety reports. Qualifications: MD degree with 5+ years of clinical development or medical monitoring experience, preferably with hands-on involvement in Phase 2-3 biotech/pharma trials. Prior experience as a practicing physician is preferred. Skills include strong communication, trend analysis, relationship building with investigators, and the ability to handle complex safety and protocol issues diplomatically. High-value biopharma specifics: focus on cardiovascular indications, immunology, inflammation, with involvement in regulatory submissions and safety signal detection. Work setup: onsite in Lexington, MA, with up to 20% domestic/international travel.