Director – Medical Monitor

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $250k - $350k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Artiva Biotherapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

💰 Series B on 2021-02

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.

📋 Description

• 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