or apply directly on Lyell Immunopharma's site. We never take the application ourselves.
Is this posting real?
- This role has been open
- 13 days Lyell Immunopharma's roles stay open a median of 26 days
- Reposted
- No
- Salary listed
- Yes 100% of Lyell Immunopharma's roles list one
- Ghost-job risk at Lyell Immunopharma
- high 5 stale, 0 reposted of 14 open
- Hiring momentum
- 20 roles opened in the last 90 days ↑ up vs. the prior 90 days
- Last confirmed on the employer's board
- 2026-09-17
Measured from postings appearing on and disappearing from Lyell Immunopharma's own greenhouse board since 2026-08-03. Full hiring picture for Lyell Immunopharma.
About this role
The Director of Medical Writing will lead the development of clinical regulatory documents for a clinical-stage company focused on next-generation CAR T-cell therapies. This role involves authoring key documents such as protocols, Investigator’s Brochures, and clinical study reports, while also managing vendor relationships and building the medical writing function. The position requires collaboration with various departments to ensure timely and accurate submissions as the company progresses towards BLA submission and commercial launch.
- benefits
- 2/5
- freshness
- 4/5
- career value
- 4/5
- role clarity
- 5/5
- pay transparency
- 5/5
Scored from the posting itself — how clearly the role is described, how much it says about pay and benefits, and how recently it was listed. Not a judgement of Lyell Immunopharma as an employer.
What you need
- 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: 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
Nice to have
- 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
What you get
- Salary range of $220,000 to $240,000 annually
- Opportunity to earn an annual bonus
- Eligibility to participate in Lyell’s Equity Incentive Plan
Worth weighing
- No specific mention of team size or structure, which may indicate a lean organization
- The role involves a significant amount of vendor management and outsourcing, which could impact workload and quality control
- The use of AI tools is emphasized, which may require adaptability to new technologies
- The position may involve high personal output and shifting priorities, indicating a fast-paced work environment
Summarised from Lyell Immunopharma's posting. Read the full original.
Listed by Lyell Immunopharma on their greenhouse job board, last confirmed open on 2026-09-17. PitchMeAI is not the employer.
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