Director, Medical Writing
Lyell Immunopharma · US
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Role summary
Lyell Immunopharma seeks a Director of Medical Writing to establish and lead medical writing capabilities for next-generation CAR T-cell therapies. The role involves authoring clinical regulatory documents across development stages while building the medical writing function toward BLA submission and commercial launch.
What they're looking for
- Extensive experience authoring clinical protocols, amendments, and investigator's brochures
- Demonstrated expertise in clinical study report writing to ICH E3 standards
- Strong knowledge of Module 2 content for regulatory submissions (CTD format)
- Experience with health authority interactions and clinical regulatory strategy
- Ability to manage vendor relationships and medical writing infrastructure
- Cell therapy or oncology background preferred but not required
What you'll be doing
- Lead authoring of clinical protocols, amendments, and investigator's brochures throughout product development
- Author clinical study reports end-to-end, including tables/listings, data interpretation, and quality control
- Develop and author Module 2 clinical summaries including efficacy, safety, and benefit-risk narratives
- Manage medical writing vendor relationships and infrastructure while personally authoring priority documents
- Partner with regulatory, clinical, and biostatistics teams to translate study designs into regulator-ready documentation
Privacy & handoff
This role links to Lyell Immunopharma's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.