Senior Clinical Trial Manager

Job not on LinkedIn

🔥 9 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $155k - $180k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Kyverna Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $85M Series B on 2022-01

Biotechnology • Pharmaceuticals • Science

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The company is pioneering CAR T-cell therapies, leveraging the transformational power of T cells to potentially provide sustained, treatment-free remission for autoimmune conditions. Kyverna's lead CAR T-cell therapy candidate, KYV-101, is advancing through clinical trials targeting various autoimmune diseases, including multiple sclerosis, myasthenia gravis, systemic sclerosis, and lupus nephritis. Their pipeline features innovative chimeric antigen receptor (CAR) T-cell therapies in both autologous and allogeneic formats aimed at B cell-driven autoimmune diseases.

📋 Description

• Lead and manage the day-to-day operational execution of assigned cell therapy trials: study startup, site activation, enrollment, monitoring, close-out. • Develop and manage study timelines, budgets, forecasts, and related operational metrics. • Partner with external vendors / CROs / service providers (monitoring, labs, imaging, manufacturing/supply chain for cell product) to ensure high quality and timely deliverables. • Serve as the primary cross-functional operational contact for study teams (clinical operations, data management, biostatistics, regulatory, safety/pharmacovigilance, manufacturing, supply chain, medical affairs, quality). • Ensure compliance with regulatory and quality standards (FDA, EMA, ICH-GCP, relevant local regulations) and internal SOPs. • Participate in protocol development and amendments, informed consent form (ICF) review, CRF/data tool development, TMF (Trial Master File) setup & maintenance, monitoring plan, data review plan, drug/cell-product accountability and reconciliation. • Oversee site feasibility, selection, contracting, start-up (site initiation visits, training, enrollment & retention strategies) and close-out activities. • Monitor study progress, identify risks/issues (enrollment delays, monitor/vendor performance, budget overruns, data quality issues) and implement mitigation strategies. • Foster effective communication across study teams, escalate issues to senior leadership as needed. • Ensure preparation for audits/inspections, maintain high standards of documentation readiness. • Contribute to lessons-learned and process improvement initiatives, particularly around cell-therapy-specific operational challenges (e.g., chain of identity/chain of custody, logistics of product, unique site training). • Review invoices and track study budget according to the forecast, working closely with finance and clinical business operations. • Develop study documents and tools including study, informed consent forms, project plans, budgets, study templates, and other materials as needed. • Vendor Management – Contribute to or lead cross-program vendor management activities. • Contribute to SOP development within the Clinical Operations team

🎯 Requirements

• B.S. degree with minimum 5+ years of experience in clinical operations including managing clinical trials in biotech, pharmaceutical. • Strong clinical study conduct experience from start-up through close-out. • Strong leadership, effective decision making, and problem-solving skills required. • Established Cell Therapy /CAR T study experience required. • Working knowledge of relevant GCPs and FDA/EMA regulations. • Knowledgeable of current ICH GCP guidelines and applicable regulations. • Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials. • Experience in small/mid biotechnology environment (startup mindset). • Excellent written and verbal communication skills.

🏖️ Benefits

• Bonus • Benefits • Participation in the company’s stock plan