Director, Medical Writing

Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. And for patients with hematologic malignancies, there is a need for next-generation cell therapies that can deliver increased response rates and longer duration of response.  We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell’s product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to advance next-generation CAR T-cell therapies, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency.

We are seeking a Director of Medical Writing to build Lyell’s medical writing capability; initially operating as author and independent owner of our clinical regulatory documents, with long term responsibility for building out the function as we advance our cell therapy portfolio through BLA submission and into commercial launch.

Reporting to the VP of Regulatory Affairs, this individual will partner with Regulatory and Clinical Development providing responsive, available, and action-focused support, able to turn a design discussion into draft text quickly. Recurring deliverables are protocols, protocol amendments, Investigator’s Brochures, and clinical study reports, which move on clinical timelines and cannot slip. In parallel, you will author Module 2 clinical summary content as the submission takes shape.

This is a player-coach role in a lean organization.  You will own vendor management and medical writing infrastructure while personally authoring priority documents, with the internal-versus-outsourced split refined as the program matures. Contribution on CMC technical writing or health authority briefing documents is a differentiator, not an entry requirement.

• Author Module 2.5 (Clinical Overview) and the Module 2.7 series: clinical efficacy, safety, clinical pharmacology, and benefit-risk.
• Develop the clinical submission content plan: storyline across modules, data dependencies, and consistency across clinical summaries, protocols/CSRs, and labeling.
• Partner with Regulatory Affairs on eCTD granularity, cross-referencing conventions, and submission-readiness review.

• Own selection, onboarding, and performance management of medical writing CROs, freelance writers, and functional service providers.
• Build the operating model: scoping, SOWs and budgets, timeline negotiation, capacity forecasting, escalation paths, and the build-versus-buy calls behind them.
• Enforce quality on outsourced work, ensuring that final product reflects Lyell and our best thinking.

• Establish and maintain templates, style guide, authoring conventions, and medical writing SOPs and work instructions.
• Implement or optimize document management, collaborative authoring, and reference management systems suited to a lean team that are scalable as we grow.
• Lead comment resolution and review meetings, drive documents to closure across competing priorities, and support inspection readiness and audit response on document control.

• One writer supporting continuous clinical deliverables and a marketing application cannot scale through effort alone. This role uses AI tooling as a force multiplier and manages our AI medical writing vendor relationship.  Apply AI to multiple layers of work; authoring, quality control, and managing company data within guidelines. Manage AI medical writing vendor(s) and all steps in the process ensuring AI is an input and outputs are clearly authored by Lyell’s team, aligning with the guidance of “human in the lead”.