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Artiva Biotherapeutics

Director – Medical Monitor

Artiva Biotherapeutics

Senior Director/Sr. Director, Medical Monitor overseeing clinical trials at biotechnology company Artiva.

Posted 7/5/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $250,000 - $350,000 per yearWebsite

Tech Stack

Tools & technologies
Google Cloud Platform

About the role

Key responsibilities & impact
  • 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

What you’ll need
  • 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

Comp & perks
  • 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

ATS Keywords

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Hard Skills & Tools
Clinical Data ReviewAdverse Event AssessmentCausality AssessmentSafety Signal DetectionProtocol DevelopmentData Quality AssuranceBiomarker StrategiesTrial Execution SupportPatient ManagementRisk-Benefit Decision Making
Soft Skills
Clear CommunicationCollaborationCredibility with InvestigatorsCross-Functional TeamworkAdaptability in Fast-Moving Environments
Certifications
Board Certification in Rheumatology