Senior Manager, Clinical Site Budgets and Outsourcing - contract position

Job description

Senior Manager, Clinical Site Budgets and Outsourcing - Temporary Contract Position

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.

Responsibilities

Support the Clinical Development organization at a pivotal point in the company's growth. This role owns the outsourcing lifecycle for assigned US and ex-US clinical programs under Lyell's Clinical Development portfolio – vendor selection, financial due diligence, contract and change order negotiations, ongoing vendor performance, and spend management – in support of Clinical Development, Drug Safety, and Regulatory. It is also the primary owner of clinical trial site budgets across assigned studies, including review and negotiation. Partnering closely with Clinical Operations, Finance, Legal, and CRO partners, the successful candidate will ensure outsourced activities and site budgets are executed on time, within budget, and in compliance with company policy and applicable regulations (e.g., GCP). The position is responsible for ensuring a high level of fiscal discipline with a focus on fair market value (FMV) benchmarking and budget-to-actual tracking across assigned studies.

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

The contract hourly rate for this role is between $86.00 - $96.00 per hour. At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees. Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws. We've learned from experience that some of the best people don't always match our requirements perfectly - if you're interested and think you could fit, please don't hesitate to apply.

Worksite address

seattle, WA, 98127, US

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.