Manager, Clinical Budgets and Contracts

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

About This Role

Axsome Therapeutics is seeking a Manager, Clinical Budgets and Contracts to assist in the financial oversight of Axsome-sponsored clinical trials. Primary responsibilities include developing and negotiating site budgets and supporting clinical trial accruals, site payments, and financial reporting. Candidates are expected to have strong knowledge of clinical trials and an understanding of clinical trial site and vendor contracting. The role will work closely with the Finance, Legal and Clinical teams.

This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.

Job Responsibilities and Duties include, but are not limited to, the following

• Lead, in conjunction with the study team, the development of clinical trial site budgets
• Build and perform QC of finalized site budget templates in the site payment system
• Lead the negotiation of clinical trial site budgets and payment terms and liaise with Legal on contract negotiations, as needed
• Perform internal QC review of finalized site budgets
• Participate in vendor evaluations and lead vendor budget and contract negotiations for assigned vendors or trials
• Function as the Site Payment Lead for assigned clinical trials
• Address site invoicing queries and facilitate visit and invoice payment approvals
• Generate site payment reports, as needed
• Assist with subject visit accrual and accrual validation for assigned trials
• Assist with subject visit and subject visit cost forecasting by working closely with study teams to understand protocol design and realistic study timelines
• Work closely with Data Management and Finance to ensure accurate site budget template builds and timely site payments from start-up through close-out
• In collaboration with Compliance and Finance, assist with annual reporting of site investigator payments to CMS
• Work with Finance and study teams to reconcile site payments and facilitate study close-out payments
• Help maintain a repository of site master budgets and research fee dashboards to support transparent site and study budget comparisons
• Support the financial audit process, as needed
• Identify opportunities to enhance existing procedures and improve utilization of financial system tools
• Support and lead project initiatives related to the role
• Perform other related duties as assigned

Requirements / Qualifications

• Bachelor’s degree from an accredited college or university
• At least 5 years of experience in the clinical research industry, including at least 3 years of direct budget negotiation experience
• Excellent analytical skills, including advanced proficiency in Excel and the ability to quickly manipulate and analyze large data sets and build reports
• Experience using project management tools such as Smartsheet and data processing tools such as Power BI
• Ability to work on site Monday, Tuesday, and Thursday. We are unable to consider candidates seeking fully remote roles

Experience, Knowledge and Skills