---
title: 'Director, Medical Writing at Lyell Immunopharma'
canonical: 'https://feeny.ai/job/director-medical-writing-lyell-immunopharma-united-states-vhfy2mbbyfy2'
type: 'job'
last_seen: '2026-09-13'
---

# Director, Medical Writing at Lyell Immunopharma

- **Company:** Lyell Immunopharma
- **Location:** United States
- **Posted:** 2026-09-03
- **Last confirmed live:** 2026-09-13
- **Apply:** https://job-boards.greenhouse.io/lyellimmunopharma/jobs/7986060003

## 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.

## About Lyell Immunopharma

## Company Overview
- **One-liner**: Lyell Immunopharma is a clinical-stage biotechnology company advancing next-generation CAR T-cell therapies designed to deliver durable remissions for patients with cancer.
- **Entity Type**: Public (ticker not explicitly confirmed in provided sources; investor relations page indicates public reporting)  
- **Headquarters**: South San Francisco, California, United States  
- **Founded**: Not publicly available from provided sources  
- **Founders**: Rick Klausner, M.D. (Founder & Chairman), Crystal Mackall, M.D. (Founder), Stan Riddell, M.D. (Founder)  

## Core Business
- **Primary industry**: Biotechnology – Cell Therapy / Oncology  
- **Target customers**: B2B (healthcare providers, clinical trial sites, and patients seeking one-time cell therapies)  
- **Mission / purpose**: “To fully realize the curative potential of cell therapy for patients with cancer” – advancing next-generation CAR T cells that provide potent, long-lasting responses in both hematologic malignancies and solid tumors.  

## Products & Services
- **Ronde-Cel (LYL797)**: A next-generation CAR T-cell product candidate targeting ROR1 in solid tumors; currently presenting clinical and translational data at conferences like ASH 2025.  
- **Other pipeline candidates**: Multiple undisclosed product candidates for hematologic malignancies and solid tumors, designed with novel CAR constructs, T-cell exhaustion‑resistance technologies, and proprietary manufacturing protocols.  

## Market Standing
- **Valuation / Market Cap**: Not publicly available from provided sources  
- **Key Metric**: Clinical-stage; no approved product yet. Most recent disclosed financing is a $50 million tranche of equity private placement (closed April 2026).  
- **Notable Investors / Partners**: Not explicitly listed in provided data; investors likely include those from private placements and institutional holders (details not available).  
- **Growth Signals**:  
  - Clinical progress with Ronde-Cel in solid tumors  
  - State-of-the-art manufacturing facility in Bothell, WA, approved for clinical and commercial production  
  - Active pipeline across hematologic and solid tumor indications  
  - Establishment of three West Coast hubs (South San Francisco HQ, Seattle, Bothell)  

## Competitive Advantages
- **Proprietary T-cell biology**: Pioneering approaches to prevent T-cell exhaustion, enabling longer‑lived and more potent cancer killing.  
- **End‑to‑end control**: Own and operate a dedicated manufacturing facility, ensuring supply chain control and product quality.  
- **Founding by cell‑therapy pioneers**: Founders (Klausner, Mackall, Riddell) are leaders in the field, providing deep scientific expertise.  

## Strategic Focus
- **Pipeline advancement**: Progress next‑generation CAR T candidates through clinical trials, aiming to improve outcomes over first‑generation CAR T therapies.  
- **Solid tumor expansion**: Aggressively develop therapies for solid tumors where current cell therapies have limited efficacy.  
- **Manufacturing scale‑up**: Leverage internal manufacturing to accelerate development and eventual commercialization.  

## Why Work Here
- **Culture**: Described as “grounded in science, infused with courage, and powered by respect and collaboration.” Employees report feeling welcomed and able to contribute, with diverse perspectives valued.  
- **Work model**: Hybrid – in‑office collaboration days and weekly lunches; offices in South San Francisco, Seattle (South Lake Union), and Bothell.  
- **Benefits**:  
  - Comprehensive medical, dental, vision (up to 100% premium for employees, 85% for dependents)  
  - Employee Stock Purchase Plan (ESPP) with 15% discount  
  - 401(k) matching  
  - FSA/HSA options  
  - Company‑sponsored life insurance, short‑ and long‑term disability  
  - Paid vacation and sick time  
  - Commuter benefit  
  - Wellness program (mental health, physical fitness, financial wellness)  

## Sources
1. [Lyell.com – Company Overview](https://www.lyell.com/)  
2. [Lyell.com – Careers](https://www.lyell.com/careers/)  
3. [Lyell.com – Job Openings](https://www.lyell.com/careers/job-openings/)  
4. [Lyell.com – Investor Relations](https://ir.lyell.com/investor-relations)  
5. [Lyell.com – Leadership](https://www.lyell.com/about/leadership/)

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