Director / Sr. Director, Medical Monitor

Artiva Biotherapeutics•San Diego, CA

1d•$250,000 - $350,000

About The Position

The Senior Director/Sr. Director, Medical Monitor provides medical oversight and safety monitoring across Artiva's clinical trials, ensuring participant safety, data integrity, and regulatory compliance throughout study conduct. This role requires an experienced physician with strong clinical judgment and hands-on medical monitoring experience in Phase 2-3 studies, who collaborates effectively across functions while thriving in a fast-moving biotech environment.

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.
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.
Models transparency, collaboration, and patient-centric decision-making.

Nice To Haves

Rheumatologist with Board certification preferred.

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.