Director – Medical Monitor

🕒 July 5

🏄 California – Remote

🏄 California – Remote

💵 $250k - $350k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 10%

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Artiva Biotherapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

💰 Series B on 2021-02

Biotechnology • Healthcare • Pharmaceuticals

Artiva Biotherapeutics is an immunotherapy company dedicated to making safe and effective cell therapies accessible to any cancer patient who may benefit. The company specializes in producing off-the-shelf, allogeneic NK cell therapies at a massive scale. Its mission focuses on developing effective, safe, and accessible therapies for patients suffering from autoimmune diseases and cancers. Notably, their lead program, AlloNK®, is a non-genetically modified NK cell therapy candidate currently undergoing clinical trials for treatments of systemic lupus erythematosus and Non-Hodgkin Lymphoma, among others.

📋 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