Director, Medical Writing

The role

The Director of Medical Writing will build Lyell's medical writing capability and act as the primary author for clinical regulatory documents. This player-coach role involves managing vendors and establishing medical writing infrastructure as the company advances its cell therapy portfolio.

What you will do

• Lead author for protocols and amendments
• Own the Investigator’s Brochure lifecycle
• Author Clinical Study Reports to ICH E3 end-to-end
• Author supporting documents including ICF templates, DSURs, and clinical sections of annual reports
• Author Module 2.5 and the Module 2.7 series
• Develop the clinical submission content plan
• Partner with Regulatory Affairs on eCTD granularity and submission-readiness
• Select, onboard, and manage performance of medical writing CROs and freelancers
• Build the medical writing operating model including scoping, budgets, and timelines
• Establish and maintain templates, style guides, and medical writing SOPs

Required qualifications

• 10+ years of medical writing in biotech or pharma
• Substantial time in clinical regulatory writing
• Lead-author depth on protocols, amendments, and Investigator’s Brochures
• 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
• Ability to read, interpret, and challenge statistical output
• 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

Nice to have

• Advanced degree (PhD, PharmD, MD, MS) in life sciences
• 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
• Structured content management or automated document assembly
• EMA/PRIME or other ex-US submission requirements
• AMWA or RAPS certification

Benefits

• Annual bonus
• Lyell’s Equity Incentive Plan

About the company

Lyell is a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. The company is fully integrated, capable of discovering new technologies, translating science into therapies, manufacturing products, and clinically evaluating them.