HHiring Reality
← Lyell Immunopharma

Director, Medical Writing

Lyell Immunopharma
Location
USA
Posted
17 days ago
Department
Regulatory Affairs
Salary
$220,000 to $240,000
What they actually want (must-haves)
  • 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 the job really is

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
  • Salary range of $220,000 to $240,000 annually
  • Opportunity to earn an annual bonus
  • Eligibility to participate in Lyell’s Equity Incentive Plan
Things to weigh
  • 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
Job score4/5
Benefits2/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency5/5

Applying to Lyell Immunopharma?

See how your résumé matches this role — and tailor it from what actually gets interviews.