The Sr. Clinical Trial Manager will lead the operational execution of cell therapy clinical trials from study startup through close-out. This role involves managing study timelines, budgets, vendor relationships, and cross-functional teams to ensure regulatory compliance and high-quality data.
Kyverna Therapeutics
17 Remote Job Openings at Kyverna Therapeutics
Sr. Director, Corporate Compliance
Kyverna Therapeutics
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Full Time
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13 days ago
Kyverna Therapeutics
Develop and lead the enterprise compliance program to transition the company from clinical to commercial stage. Establish the vision, strategy, and governance to manage regulatory and ethical risks across the organization.
Lead the strategy and execution of transitioning the Trial Master File function from an outsourced to an in-house model. Ensure all study TMFs are inspection-ready and aligned with global regulatory expectations through governance and quality control.
Lead the company's technology strategy and transition from a development-stage biotech to a commercial organization. Oversee enterprise applications, cybersecurity, infrastructure, and GxP validation while partnering with cross-functional business leaders.
Executive Director, Regulatory Affairs
Kyverna Therapeutics
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Full Time
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a month ago
Kyverna Therapeutics
Lead global regulatory strategy for cell therapy programs from early development through commercial launch and post-approval lifecycle management. Serve as the primary interface with health authorities like the FDA and EMA to negotiate labeling and ensure regulatory compliance.
Inspection Readiness Project Manager (Contract)
Kyverna Therapeutics
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Full Time
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a month ago
Kyverna Therapeutics
Lead enterprise-wide inspection readiness and remediation activities across clinical programs to ensure compliance with global health authorities. Orchestrate cross-functional efforts between Quality, Clinical Operations, and Regulatory teams to maintain a continuous state of readiness.
Lead the development and execution of the U.S. commercial sales and go-to-market strategy for CAR-T therapies for autoimmune diseases. Build and scale a high-performing specialty sales organization focused on treatment center activation and market penetration.
Provide strategic quality oversight and partnership management for CDMOs across plasmid, viral vector, and cell therapy manufacturing. Lead batch release activities and ensure compliance with cGMP regulations and internal quality standards.
Lead and manage complex cross-functional development programs for novel engineered T cell therapies to achieve corporate goals. Translate program strategy into integrated development plans while driving execution against timelines and milestones.
Senior Vice President, Manufacturing and Supply
Kyverna Therapeutics
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Full Time
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2 months ago
Kyverna Therapeutics
Build and lead the manufacturing and supply chain function, managing external contract manufacturers and internalizing capabilities for CAR T therapies. Oversee clinical supply, strategic sourcing, and operational budgets while ensuring network readiness for pivotal studies and commercial launch.
Director, CAR T Channel Strategy & Operations
Kyverna Therapeutics
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Full Time
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2 months ago
Kyverna Therapeutics
Develop and execute commercial channel infrastructure and strategies to support the delivery of CAR T therapies. Lead partnerships with 3PLs and specialty pharmacies while optimizing gross-to-net performance and ensuring regulatory compliance.
Executive Director, Lifecycle Lead New Technologies
Kyverna Therapeutics
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Full Time
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2 months ago
Kyverna Therapeutics
Lead strategic development programs across the full product lifecycle from early research through commercial launch and lifecycle management. Drive integrated asset strategies for emerging therapeutic platform technologies to maximize program value and align with corporate objectives.
Associate Director, Safety and Pharmacovigilance
Kyverna Therapeutics
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Full Time
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2 months ago
Kyverna Therapeutics
Lead signal detection, risk management, and the drafting of aggregate safety reports and regulatory responses. Manage safety vendor relationships to ensure compliance and quality of outsourced pharmacovigilance activities.
Vice President, Lifecycle Leader
Kyverna Therapeutics
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Full Time
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2 months ago
Kyverna Therapeutics
Lead the Program and Portfolio Lifecycle Leadership function to define and execute integrated development and commercialization strategies for autoimmune CAR-T programs. Establish governance frameworks and provide strategic oversight to ensure alignment across clinical, regulatory, manufacturing, and commercial functions.
Sr. Director, Field Market Access
Kyverna Therapeutics
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Full Time
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2 months ago
Kyverna Therapeutics
Lead the field market access organization to drive coverage and reimbursement for cellular therapies across payers and treatment centers. Serve as a strategic leader and player/coach responsible for building relationships with Medicaid, national, and regional payers.
Medical Science Liaison (MSL)/Senior Medical Science Liaison (MSL) - West Coast
Kyverna Therapeutics
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Full Time
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2 months ago
Kyverna Therapeutics
The MSL serves as a field-based scientific expert engaging with healthcare professionals and KOLs to communicate clinical data regarding CAR-T therapy programs. They are responsible for executing territory strategies, supporting clinical trial enrollment, and gathering medical insights to inform internal development.
Medical Director/Sr. Medical Director, Clinical Development
Kyverna Therapeutics
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Full Time
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3 months ago
Kyverna Therapeutics
Serve as the physician lead for CAR T-cell therapy clinical trials in autoimmune disease indications. Oversee medical monitoring of clinical trials and partner with cross-functional teams to ensure alignment on strategy and execution.