Jobs at Lyell Immunopharma

Leads FP&A activities including budgeting, forecasting, monthly reporting, variance analysis, financial modeling, KPI tracking, and performance management. Partners with R&D, Clinical, G&A, Commercial, HR, Accounting, and other leaders to assess spending, headcount, CRO and vendor costs, and business drivers. Improves FP&A systems, reporting, data integration, automation, forecasting methodologies, and financial discipline while providing actionable insights for resource allocation and decision-making.

Lead strategic and operational execution of clinical development programs from Phase 1 through approval and lifecycle management. Coordinate cross-functional teams across clinical operations, CMC, regulatory, biometrics, quality, pharmacovigilance, finance, and external vendors. Own integrated plans, timelines, budgets, risks, resources, governance, reporting, and submission readiness for IND, BLA, NDA, and MAA milestones. Mentor project managers, improve clinical program management processes, and support cell therapy or oncology development programs.

Owns clinical outsourcing and trial site budget activities for biotech clinical programs. Responsibilities include vendor selection, RFPs, contract and change-order negotiations, CRO oversight, site budget development, fair-market-value benchmarking, Medicare Coverage Analysis, spend tracking, forecasting, accrual support, and financial management. Partners with Clinical Operations, Finance, Legal, Regulatory, Drug Safety, CROs, and clinical sites to ensure compliant, timely, and financially disciplined execution across US and international studies.

Leads investor relations and corporate communications strategy for a clinical-stage biotech company. Translates complex scientific and clinical developments into compelling investor, analyst, media, and stakeholder messaging. Responsibilities include managing filings, press releases, conferences, roadshows, corporate content, executive communications, media relations, crisis response, spokesperson preparation, brand campaigns, and regulatory accuracy while collaborating with Finance, Legal, executives, and product teams.

Provides CMC regulatory expertise across the product lifecycle for cell therapies. Leads regulatory risk assessment, submission planning, timelines, and CMC content for INDs, amendments, IMPDs, CTAs, BLAs, and MAAs. Coordinates regulatory projects, supports FDA and global health-authority interactions, and develops lifecycle-management practices, templates, and tools. Collaborates cross-functionally with CMC and regulatory teams in a fast-paced biotechnology environment.

Leads global regulatory strategy for CAR-T cell therapy programs from early clinical development through licensure and lifecycle management. Responsibilities include developing regulatory strategies, managing FDA and EMA interactions, leading IND, CTA, BLA, and MAA submissions, mitigating regulatory risks, reviewing clinical and non-clinical documents, collaborating with CMC and clinical teams, monitoring regulatory intelligence, and mentoring regulatory staff.

Lead commercial strategy and launch planning for Lyell's first product, partnering across functions to define indication strategy, brand positioning, market access, budget and KPIs; build commercial infrastructure, vendor relationships, and a high-functioning team to ensure launch readiness and long-term commercial success.

Provide QA leadership and oversight across cell therapy product lifecycle activities including PPQ/validation for LVV, plasmids and drug product; partner with CDMOs and cross-functional teams for process implementation, tech transfer, regulatory submission (IND/BLA) support, inspection readiness, and management of deviations, CAPAs, and change controls to ensure GMP compliance.

Lead clinical-science support for CAR T and cell therapy trials, partnering with medical monitors and cross-functional teams to design protocols, oversee study execution and safety monitoring, analyze and interpret clinical/translational data, support regulatory submissions, manage publications, and collaborate with external stakeholders and vendors to ensure scientific rigor and trial success.