Executive Director, Medical Writing
Remote
Regulatory Affairs /
Full Time /
Remote
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Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what's possible.
Title: Executive Director, Medical Writing
Reports to: Chief Regulatory Officer
Location: Emeryville (Hybrid) OR Remote (West coast hours preferred)
Position Summary
The Executive Director, Medical Writing serves as the functional lead for Medical Writing, providing strategic and operational leadership across the full product lifecycle. This role is responsible for establishing the vision, operating model, and capabilities of the Medical Writing function while ensuring the delivery of high-quality, scientifically rigorous, and submission-ready documentation that supports Kyverna's development, regulatory, and commercialization objectives.
As a key member of the Regulatory leadership team, the Executive Director partners closely with Regulatory Affairs, Clinical Development, Clinical Operations, Biometrics, Medical Affairs, Pharmacovigilance, Quality, and Program Leadership to translate portfolio priorities into effective medical writing strategies and execution plans. This individual influences functional and portfolio decisions through operational expertise, identifies and mitigates regulatory documentation risks, and builds organizational capabilities that enable successful global submissions and lifecycle management.
Responsibilities
- Lead the Medical Writing function, its strategic direction, operating model, and capabilities to support Kyverna's evolving development portfolio.
- Develop departmental goals and operational priorities aligned with organizational objectives and Regulatory Affairs strategies.
- Serve as the functional representative on cross-functional governance and program teams, providing expert guidance on document strategy, planning, and execution.
- Build a high-performing organization capable of supporting clinical development, regulatory submissions, and commercialization.
- Provide executive oversight for the planning, development, review, and delivery of complex regulatory and scientific documents across all stages of product development and lifecycle management, including: Clinical study protocols, Investigator's Brochures, Clinical Study Reports, INDs, BLAs, and other global regulatory submissions, Health Authority briefing packages and responses, Labeling support documents, Post-approval lifecycle management documentation, Safety and pharmacovigilance documentation, as applicable.
- Partner with Regulatory Affairs leadership to develop integrated document strategies that support global submission objectives.
- Provide scientific and regulatory guidance on complex content development, messaging, and submission readiness.
- Ensure all documents meet applicable regulatory requirements and company quality standards.
- Partner with senior leaders across Clinical Development, Regulatory Affairs, Biometrics, Clinical Operations, Medical Affairs, Pharmacovigilance, Quality, and Program Management to proactively identify documentation needs and execution risks.
- Influence cross-functional planning by providing operational insight into submission strategy, resource requirements, timelines, and regulatory deliverables.
- Lead resolution of complex issues affecting regulatory documentation quality, timelines, or submission readiness.
- Represent Medical Writing during regulatory inspections, due diligence activities, and partner interactions, as appropriate.
- Recruit, develop, and retain a high-performing Medical Writing organization.
- Establish organizational structure, workforce planning, and succession strategies that support business growth.
- Foster a culture of scientific excellence, accountability, collaboration, and continuous improvement.
- Coach and develop leaders within the function while establishing clear performance expectations and career development opportunities.
- Develop and oversee departmental processes, standards, templates, metrics, and governance to ensure consistent, efficient execution.
- Lead resource planning and capacity management across internal staff and external partners.
- Oversee departmental budget planning and vendor strategy, ensuring appropriate utilization of external medical writing resources.
- Drive continuous improvement initiatives that enhance quality, efficiency, scalability, and regulatory compliance.
Qualifications
- Advanced degree in life sciences, pharmacy, medicine, or related discipline (PhD, PharmD, MD, or equivalent preferred).
- 12+ years of progressive medical writing experience within the biotechnology or pharmaceutical industry, including significant leadership experience.
- Demonstrated success leading Medical Writing organizations supporting global clinical development and regulatory submissions.
- Deep understanding of global regulatory requirements and guidance (FDA, EMA, ICH) across the product lifecycle.
- Experience supporting major regulatory submissions, including INDs, BLAs, MAAs, and lifecycle management activities.
- Proven 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.
- Demonstrated ability to manage multiple complex programs while balancing strategic priorities with operational execution.
The national salary range for this position is $275K to $300K USD annually. The salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company's stock plan.
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