Director, Medical Writing

Lyell Immunopharma

3d•$220,000 - $240,000

About The Position

We are seeking a Director of Medical Writing to build Lyell’s medical writing capability. Initially, this role will operate as an author and independent owner of clinical regulatory documents, with long-term responsibility for building out the function as the company advances its 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, capable of quickly transforming design discussions into draft text. Recurring deliverables include protocols, protocol amendments, Investigator’s Brochures, and clinical study reports, which must adhere to clinical timelines. In parallel, the role will involve authoring Module 2 clinical summary content as the submission takes shape. This is a player-coach role in a lean organization, requiring ownership of vendor management and medical writing infrastructure, alongside personal authorship of priority documents. The internal-versus-outsourced split will be refined as the program matures. Contribution to CMC technical writing or health authority briefing documents is considered a differentiator, not an entry requirement.

Requirements

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.
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, including 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.
Advanced degree (PhD, PharmD, MD, MS) in life sciences preferred; equivalent experience with a demonstrated authoring record considered.

Nice To Haves

Cell or gene therapy experience (CAR-T, TIL, TCR-T, or other engineered cell products).
Technical fluency to contribute to CMC documentation or prior Module 2.3 authorship.
Experience with FDA briefing documents or advisory committee materials.
Experience with accelerated pathways: RMAT, Breakthrough Therapy, Fast Track, Accelerated Approval, or Priority Review.
Experience implementing or governing AI-assisted authoring in a GxP or submission context, including tool qualification, SOP development, data handling controls, or documentation of human review.
Experience with structured content management or automated document assembly.
Experience with EMA/PRIME or other ex-US submission requirements.
AMWA or RAPS certification.

Responsibilities

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, including annual updates, safety-driven revisions, and manufacturing or product changes, ensuring the benefit-risk narrative remains accurate as the data set matures.
Author Clinical Study Reports to ICH E3 end-to-end, including TLF shell review, data interpretation, draft cycles, comment resolution, and QC.
Author supporting documents such as ICF templates, DSURs, clinical sections of annual reports, and synopses.
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, including 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, including scoping, SOWs and budgets, timeline negotiation, capacity forecasting, escalation paths, and build-versus-buy decisions.
Enforce quality on outsourced work, ensuring the final product reflects Lyell and its 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 for growth.
Lead comment resolution and review meetings, drive documents to closure across competing priorities, and support inspection readiness and audit response on document control.
Utilize AI tooling as a force multiplier and manage the AI medical writing vendor relationship, applying AI to authoring, quality control, and managing company data within guidelines.
Contribute to CMC technical writing support, including Module 2.3 (Quality Overall Summary) and maintaining consistency between quality and clinical narratives on characterization, comparability, and potency.
Contribute to health authority briefing documents, including Type B/C/D and pre-BLA packages, information request responses, and advisory committee materials.