Manager, Clinical Site Budgets

Responsibilities

• Partner with Clinical Operations, Clinical Development, Finance and external parties to develop study-specific site budget templates and negotiation parameters.
• Develop, review, and negotiate clinical trial site budgets in alignment with fair market value (FMV) guidelines and study specific parameters.
• Lead or support contract negotiations within approved financial and legal parameters.
• Manage the end-to-end contract lifecycle, including Clinical Trial Agreements (CTA), Master Services Agreements (MSA), Statements of Work (SOW), amendments, and change orders.
• Partner with Clinical Operations and Legal to develop site contracting timelines, documents, track progress and provide regular updates to study teams and internal stakeholders.
• Manage the site clinical trial agreement (CTA) development timeline.
• Partner closely with Legal on contract review, redlines, risk assessment, and resolution of contractual issues.
• Review and analyze budgets, payment terms, milestones, and pass-through costs to ensure accuracy and alignment between executed contracts, approved budgets, and forecasts.
• Monitor and track contract and budget changes that impact scope, cost, or timelines; escalate risks and issues as appropriate.
• Utilize internal and external benchmarking data to perform site budget analyses and support negotiation recommendations.
• Support study-level budgeting, forecasting, and variance management activities as needed.

Qualifications

• BS/BA degree and a minimum of 6 years of relevant and progressive experience.
• 4+ years of direct clinical site budget negotiation experience.
• Deep understanding of the drug development process and cross-functional responsibilities.
• Knowledgeable in the use of industry benchmarking data sets (e.g., Grantplan, Medicare, etc.).
• Proven track record of supporting financial processes, including budgeting/forecasting and variance management.
• Effective and collaborative problem-solving skills.
• Ability to multi-task within and across projects and prioritize and manage timelines effectively.
• Strong analytical and modeling skills and able to make data-driven recommendations.
• Strong interpersonal, communication and presentation skills to be able to engage with all levels both internally and externally.
• Able to apply good judgement and professional expertise in new situations.
• Experience in pharmaceutical/biotech industry required.
• Experience with oncology, auto-immune, or cell-therapy preferred.
• Experience with US and global site budgets preferred.
• Experience with complex trial designs preferred.

Working conditions & physical requirements

• This is an onsite position at company headquarters with the expectation to work onsite during business hours, a minimum of 4 days per week.
• Travel may be required (up to 20%)​.
• Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels. ​

Compensation

• The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.
• Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
• The anticipated salary range for this role is $140,000 - $160,000