Senior Manager, Clinical Site Budgets and Outsourcing - Temporary contract position
Lyell ImmunopharmaSeattle, Washington, United States · Posted 3 days agoDescription
Responsibilities:
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
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