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$250k–$350k/yr
Full-time
postgraduate degree
Medical Insurance, Dental Insurance, Vision Insurance, Group Life Insurance, Long Term Disability, 401(k) Retirement Plan
Posted 38d ago
~40 hrs/week
Remote in United States
Responsibilities
Provide medical oversight and safety monitoring for Phase 2-3 clinical trials to ensure participant safety and data integrity. Collaborate with cross-functional teams and investigators to manage protocol interpretation and regulatory compliance.
Requirements
Requires an MD with 5+ years of clinical development experience and a background in immunology, rheumatology, or cell therapy. Must have hands-on medical monitoring experience in Phase 2-3 trials and a strong understanding of GCP.
Full job description
About Artiva:
We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate,AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, creates an opportunity to generate potentially transformative therapies.
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.
Duties/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
Models transparency, collaboration, and patient-centric decision-making.
In addition to a great culture, we offer:
A beautiful facility
An entrepreneurial, highly collaborative, and innovative environment
Comprehensive benefits, including:
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
Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.
If all this speaks to you, come join us on our journey!
Base Salary: $250,000 - 350,000. Exact compensation may vary based on skills and experience.
Related keywords
NK Cell TherapyAutoimmune DiseasesRheumatologyImmunologyPhase 2-3 StudiesAlloNKDSURNDABLAMAAGCPClinical DevelopmentBiotechnologyMedical MonitorSafety Signal DetectionBiomarkers
We are dedicated to making safe and effective cell therapies accessible to any cancer patient who may benefit.
Industry
Biotechnology Research
Company size
51-200 employees
Founded
2019
Headquarters
San Diego, California
LinkedIn followers
14,455
Total funding
$498M
Artiva Biotherapeutics is an immunotherapy company with the ability to produce off-the-shelf, allogeneic NK cell therapies at a massive scale. Our mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases and cancers. Our lead program, AlloNK®, is an allogeneic, non-genetically modified NK cell therapy candidate designed to enhance the activity of monoclonal antibodies or NK cell engagers. AlloNK is currently in clinical trials in combination with rituximab for treatment of systemic lupus erythematosus (SLE) in patients with active lupus nephritis and for treatment of Non-Hodgkin Lymphoma, as well as in combination with Affimed’s innate cell engager AFM13 for the treatment of patients with relapsed/refractory CD30-positive lymphomas.
Offices: 5505 Morehouse Drive, Suite 100, San Diego, California 92121, US