Director, Medical Writing
Lyell Immunopharma
September 03, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Director of Medical Writing
Key Responsibilities
- Lead author for protocols and amendments; turn study design into regulator-ready text with Clinical Development, Biostatistics, Clinical Operations, and Safety.
- Own Investigator’s Brochure lifecycle (annual updates, safety-driven revisions, manufacturing/product changes) and maintain accurate benefit-risk narrative.
- Author Clinical Study Reports (ICH E3 end-to-end: TLF review, data interpretation, draft cycles, comment resolution, QC).
- Author supporting documents: ICF templates, DSURs, clinical sections of annual reports, and synopses.
- Author Module 2 content: Module 2.5 (Clinical Overview) and Module 2.7 series (efficacy, safety, clinical pharmacology, benefit-risk).
- Build the clinical submission content plan and ensure consistency across modules, protocols/CSRs, and labeling; partner with Regulatory on eCTD granularity and readiness review.
- Manage medical writing CROs/freelancers/service providers (selection, onboarding, performance), build operating model (SOWs/budgets, timelines, capacity, escalation, build-vs-buy), and enforce quality.
- Establish templates, style guide, SOPs, and scalable document/reference management; lead review/comment resolution, closure, and inspection/audit support.
- Use AI to increase efficiency while ensuring “human in the lead” authorship and QA; manage AI writing vendor(s).
Qualifications
- 10+ years medical writing in biotech/pharma with substantial clinical regulatory writing; lead-author depth (protocols, amendments, Investigator’s Brochures).
- Working knowledge of ICH E3, E6(R3), E2, M4E; CTD/eCTD; applicable 21 CFR requirements.
- Proven outsourced vendor scoping, budgeting, and quality oversight.
- Ability to interpret statistical output and translate into clinical narrative.
- Comfort in lean, shifting-priority environment with high personal output.
- Practical AI tooling use with described workflows and controls; PhD/PharmD/MD/MS preferred (or equivalent).
Preferred
- Cell/gene therapy experience (e.g., CAR-T, TIL, TCR-T).
- CMC/Module 2.3 exposure and/or FDA briefing/advisory committee experience.
- Knowledge of accelerated pathways (RMAT, Breakthrough, Fast Track, Accelerated Approval, Priority Review).
- AI-assisted authoring governance in GxP/submission context; structured content management/automated assembly; EMA/PRIME or ex-US experience; AMWA/RAPS.
Compensation/Benefits
- Salary range: $220,000–$240,000 annually; opportunity for annual bonus.
- Eligible for Lyell’s Equity Incentive Plan.
Key Responsibilities
- Lead author for protocols and amendments; turn study design into regulator-ready text with Clinical Development, Biostatistics, Clinical Operations, and Safety.
- Own Investigator’s Brochure lifecycle (annual updates, safety-driven revisions, manufacturing/product changes) and maintain accurate benefit-risk narrative.
- Author Clinical Study Reports (ICH E3 end-to-end: TLF review, data interpretation, draft cycles, comment resolution, QC).
- Author supporting documents: ICF templates, DSURs, clinical sections of annual reports, and synopses.
- Author Module 2 content: Module 2.5 (Clinical Overview) and Module 2.7 series (efficacy, safety, clinical pharmacology, benefit-risk).
- Build the clinical submission content plan and ensure consistency across modules, protocols/CSRs, and labeling; partner with Regulatory on eCTD granularity and readiness review.
- Manage medical writing CROs/freelancers/service providers (selection, onboarding, performance), build operating model (SOWs/budgets, timelines, capacity, escalation, build-vs-buy), and enforce quality.
- Establish templates, style guide, SOPs, and scalable document/reference management; lead review/comment resolution, closure, and inspection/audit support.
- Use AI to increase efficiency while ensuring “human in the lead” authorship and QA; manage AI writing vendor(s).
Qualifications
- 10+ years medical writing in biotech/pharma with substantial clinical regulatory writing; lead-author depth (protocols, amendments, Investigator’s Brochures).
- Working knowledge of ICH E3, E6(R3), E2, M4E; CTD/eCTD; applicable 21 CFR requirements.
- Proven outsourced vendor scoping, budgeting, and quality oversight.
- Ability to interpret statistical output and translate into clinical narrative.
- Comfort in lean, shifting-priority environment with high personal output.
- Practical AI tooling use with described workflows and controls; PhD/PharmD/MD/MS preferred (or equivalent).
Preferred
- Cell/gene therapy experience (e.g., CAR-T, TIL, TCR-T).
- CMC/Module 2.3 exposure and/or FDA briefing/advisory committee experience.
- Knowledge of accelerated pathways (RMAT, Breakthrough, Fast Track, Accelerated Approval, Priority Review).
- AI-assisted authoring governance in GxP/submission context; structured content management/automated assembly; EMA/PRIME or ex-US experience; AMWA/RAPS.
Compensation/Benefits
- Salary range: $220,000–$240,000 annually; opportunity for annual bonus.
- Eligible for Lyell’s Equity Incentive Plan.