Director – Medical Monitor

Role Overview

• Provide ongoing medical monitoring and safety oversight for assigned clinical trials, including real-time review of safety data, adverse events, and laboratory findings
• Serve as the primary medical point of contact for investigators and sites on eligibility, protocol interpretation, and patient management questions
• Engage with investigators, advisors, and external experts to support trial execution and clinical oversight
• Review and assess adverse events and serious adverse events, including causality assessment, and support safety signal detection in partnership with Pharmacovigilance
• Conduct ongoing medical and clinical data review, including data listings, protocol deviations, and eligibility, to ensure data quality and participant safety
• Provide clinical input into protocols, amendments, informed consent forms, and other study-related documents
• Review and interpret clinical and safety data to inform protocol adjustments and trial-level decisions
• Develop and maintain medical monitoring plans and safety review processes for assigned studies
• Partner closely with Clinical Operations and CROs on trial conduct, site management, and medical monitoring activities
• Partner with Biometrics and Regulatory Affairs to ensure clinical data supports statistical and regulatory requirements
• Collaborate closely with Translational Medicine, Safety/Pharmacovigilance, Regulatory Affairs, Biometrics, Medical Affairs, and CMC teams
• Provide clinical input into biomarker and safety strategies
• Contribute to safety reports, DSURs, and responses to health authority questions
• Provide clinical input into briefing documents, responses to regulatory questions, and clinical components of submissions
• Support readiness for audits, inspections, and regulatory review

Requirements

• MD required
• Hands-on medical monitoring experience in Phase 2-3 clinical trials in rheumatology or immunology indications required
• Background in immunology, autoimmune disease, rheumatology or cell therapy required
• Rheumatologist with Board certification preferred
• 5+ years of clinical development and/or medical monitoring experience in biotechnology and/or pharmaceutical organizations
• Experience supporting programs through key clinical trial milestones (e.g., study start-up, interim analyses, pivotal study conduct)
• Strong ability to integrate clinical, safety, and scientific data into sound clinical and risk-benefit decisions
• Solid understanding of global clinical development, GCP, and patient safety requirements
• Clear and credible communicator with investigators, cross-functional teams, senior management, and external experts
• Familiarity with regulatory submissions (e.g., NDA, BLA, MAA) and support of health authority interactions
• Comfortable operating as an individual contributor in a lean, fast-moving biotech environment

Tech Stack

• Google Cloud Platform

Benefits

• Medical, Dental, and Vision
• Group Life Insurance
• Long Term Disability (LTD)
• 401(k) Retirement Plan
• Employee Assistance Program (EAP)
• Flexible Spending Account (FSA)
• Paid Time Off (PTO)
• Company paid holidays, including the year-end holiday week
• Recognition program, Bonus.ly