Director, Medical Writing

Job description

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 submission-readiness review. **Vendor and Resource Management** - 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. **Process and Infrastructure** - 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. **AI-Enabled Authoring and Efficiency** - 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”. **Additional Scope — Valued, Not Required** - Differentiators in selection that may expand within the role over time: - **CMC technical writing support.** Contributing to or coordinating Module 2.3 (Quality Overall Summary) and keeping the quality narrative consistent with the clinical narrative on characterization, comparability, and potency. - **Health authority briefing documents.** Type B/C/D and pre-BLA packages, information request responses, and advisory committee materials. **Qualifications** **Required** - 10+ years of medical writing in biotech or pharma, with substantial time in clinical regulatory writing. - Lead-author depth on protocols, amendments, and Investigator’s Brochures — not coordinator or reviewer. - Working knowledge of ICH E3, E6(R3), E2, and M4E, CTD/eCTD structure, and applicable 21 CFR requirements. - Proven track record managing outsourced writing vendors: scoping, budget, and quality oversight. - Ability to read, interpret, and challenge statistical output and translate it into accurate clinical narrative. - Comfort in a resource-constrained environment with high personal output and shifting priorities. - Practical use of AI tools in a regulated or professional writing environment. Be prepared to describe specific workflows you changed and the controls you applied. - Advanced degree (PhD, PharmD, MD, MS) in life sciences preferred; equivalent experience with a demonstrated authoring record considered. **Preferred** - Cell or gene therapy — CAR-T, TIL, TCR-T, or other engineered cell products. - Technical fluency to contribute to CMC documentation or prior Module 2.3 authorship; FDA briefing documents or advisory committee materials. - Accelerated pathways: RMAT, Breakthrough Therapy, Fast Track, Accelerated Approval, or Priority Review. - Implementing or governing AI-assisted authoring in a GxP or submission context — tool qualification, SOP development, data handling controls, or documentation of human review. - Structured content management or automated document assembly; EMA/PRIME or other ex-US submission requirements; AMWA or RAPS certification. The salary range for this position is $220,000 to $240,000, annually, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell’s compensation practices and an applicant’s qualifications and experience. Employees are also eligible to participate in Lyell’s Equity Incentive Plan. At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees. Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.