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. Key Responsibilities Clinical Document Ownership — Core of the Role • Lead author for protocols and amendments, working with Clinical Development, Biostatistics, Clinical Operations, and Safety to turn study design into clear, executable, regulator-ready text. • Own the Investigator’s Brochure lifecycle — annual updates, safety-driven revisions, and manufacturing or product changes — keeping the benefit-risk narrative accurate as the data set matures. • Author Clinical Study Reports to ICH E3 end-to-end: TLF shell review, data interpretation, draft cycles, comment resolution, and QC. • Author supporting documents: ICF templates, DSURs, clinical sections of annual reports, and synopses. Module 2 Authoring • 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 subm