Lyell is a T cell reprogramming company dedicated to the mastery of T cells to cure patients with solid tumors. Backed by 8VC.
About the role
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. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Health authority briefing documents. Type B/C/D and pre-BLA packages, information request responses, and advisory committee materials
- 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
More about this role
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...
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