Executive Director, Medical Writing

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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 the Medical Writing function, including its strategic direction, operating model, and capabilities • Develop departmental goals and operational priorities aligned with organizational and Regulatory Affairs objectives • Represent Medical Writing on cross-functional governance and program teams • Build a high-performing organization supporting clinical development, regulatory submissions, and commercialization • Oversee planning, development, review, and delivery of complex regulatory and scientific documents across the product lifecycle • Develop integrated document strategies supporting global submission objectives • Provide scientific and regulatory guidance on content development, messaging, and submission readiness • Ensure documents meet regulatory requirements and company quality standards • Partner with senior leaders to identify documentation needs and execution risks • Influence submission strategy, resource requirements, timelines, and regulatory deliverables • Resolve complex issues affecting documentation quality, timelines, or submission readiness • Represent Medical Writing during regulatory inspections, due diligence activities, and partner interactions • Recruit, develop, and retain a high-performing Medical Writing organization • Establish organizational structure, workforce planning, and succession strategies • Coach and develop functional leaders • Develop departmental processes, standards, templates, metrics, and governance • Lead resource planning and capacity management across internal staff and external partners • Oversee departmental budget planning and vendor strategy • Drive continuous improvement in quality, efficiency, scalability, and regulatory compliance

🎯 Requirements

• Advanced degree in life sciences, pharmacy, medicine, or a related discipline preferred (PhD, PharmD, MD, or equivalent) • 12+ years of progressive medical writing experience in the biotechnology or pharmaceutical industry • Significant leadership experience • Demonstrated success leading Medical Writing organizations supporting global clinical development and regulatory submissions • Deep understanding of FDA, EMA, and ICH regulatory requirements and guidance across the product lifecycle • Experience supporting INDs, BLAs, MAAs, and lifecycle management activities • Ability to influence cross-functional decision-making and build collaborative relationships across senior leadership teams • Experience developing organizational capabilities, leading organizational change, and scaling teams within a growing company • Strong executive communication, leadership, and interpersonal skills • Ability to manage multiple complex programs while balancing strategic priorities with operational execution • West Coast hours preferred for remote work

🏖️ Benefits

• Bonus eligibility • Benefits • Participation in Company’s stock plan