Director – Medical Monitor
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Job Description
Senior Director/Sr. Director, Medical Monitor overseeing clinical trials at biotechnology company Artiva. Responsible for medical oversight, safety monitoring, and regulatory compliance in clinical settings.
Responsibilities:
- 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
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
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