Senior Manager, Clinical Site Budgets and… at Lyell… · Seattle

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.

Clinical Outsourcing

• Lead the identification and selection of Clinical Development vendors, including Contract Research Organizations (CROs), central labs, imaging vendors, and other specialty service providers
• Manage the documents and processes needed to select the optimal contract service provider (CSP), including RFI/RFP development, bid grid analysis, and final recommendation for stakeholders
• Negotiate contract business terms, scopes of work, master service agreements, pricing, and payment schedules within approved parameters; manage the routing of contractual documents to ensure timely and compliant execution
• Assist Clinical Development teams in defining, reviewing, validating, and negotiating vendor change orders and amendments for acceptance and execution; collaborate with Finance and Legal to provide line of sight to incremental costs for corporate planning or highlight any contractual issues
• Monitor vendor performance against contractual KPIs/SLAs and help ensure vendors/partners are delivering in line with expectations and contracts; maintain vendor oversight documentation to support oversight expectations and inspection readiness
• Participate in and help manage vendor governance meetings and day-to-day vendor relationships
• Support Finance/Accounting with general contracting queries, payment schedule interpretation and overall contract burn management

Clinical Trial Site Budgets

• Build and/or validate per-patient and per-site budget models based on protocol-required procedures, standard-of-care carve-outs, and visit schedules using FMV (fair market value) industry benchmarking data and internal precedent
• Own the review, negotiation, escalation and maintenance of clinical trial site budgets and investigator grants across assigned studies; partner with Clinical Operations to facilitate interactions with CROs and clinical sites
• Interpret and apply Medicare Coverage Analysis determinations, including routine vs. non-routine care classification, validate budget assumptions, resolve site billing questions, and support negotiation positions
• Track site-level spend against forecast, identify variances, and drive timely reforecasting
• Maintain and continuously improve budget templates, tools, trackers and standardized cost assumptions database used across studies
• Partner with Finance/Accounting to support accurate trial accrual estimates and monthly close processes

Core Competencies

• Demonstrates communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively
• Strong strategic thinking and project management skills; documentation and administration maintenance
• Exercises sound judgment and makes decisions appropriate for the organization; escalates early and with recommendations
• Results-driven; takes initiative and ownership to accomplish work; influences collaboratively to move cross functional and external partners to timely decisions
• Demonstrates flexibility and embraces change in a dynamic, rapidly growing environment
• Strives for continuous improvement and embraces innovative ideas in daily work
• Strong financial and analytical acumen; able to build, interpret, and manage complex site and vendor budgets with appropriate and supported assumptions
• Proficient with budgeting and financial tracking tools (e.g., Excel, Smartsheet)

Requirements (Education and Experience)

• Bachelor of Science or Bachelor of Arts
• Minimum 5 years of site budget and outsourcing experience in the biotech or pharmaceutical industry
• Demonstrated experience developing, negotiating, and managing clinical trial site budgets; direct clinical site experience and navigating ex-US sites from a sponsor perspective is a plus
• Experience with CRO and vendor contract negotiation and financial management, including validating CRO investigator grant assumptions; ex-US experience is a plus
• Prior leadership and managerial experience in clinical outsourcing; experience with oncology trials, including cell therapy, CAR T, or other complex trial experience is preferred
• Working knowledge of Good Clinical Practice (GCP), FDA regulations, and ICH guidelines as they relate to sponsor clinical trial conduct and sponsor vendor oversight
• Working knowledge of Medicare Coverage Analyses, CMS National Coverage Determinations, National Comprehensive Cancer Network (NCCN) Guidelines and application to support and influence budget negotiations
• Advanced proficiency embedding AI as a tool into everyday workflows and larger projects; focus on scalability in mind (Claude, etc.), is a plus