Clinical Trial Associate

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 Clinical Trial Manager/Senior Clinical Trial Manager who will be the primary operational lead for a study and will lead the cross-functional team for execution of the study. The Clinical Trial Manager/Senior Clinical Trial Manager provides operational leadership to the study team to ensure project milestones deliver on time, within budget, high quality, and in compliance with the ICH / GCP, regulatory authority’s regulations/guidelines, and applicable SOPs. This position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by the program director when needed. 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 R

ROLE SUMMARY The primary purpose of this job role is to function as a member of the Sample Logistics (SL) operations within Pfizer Vaccine Research and Development (VRD). The incumbent will be responsible for receiving samples from global clinical/study trials according to approved protocols and processes. The individual will participate in all aspects of tracking and documenting the chain of custody of samples. The incumbent’s role will include sample receipt, documentation, storage, tracking, aliquoting, distribution to the testing labs, and sample disposal. The colleague will work in a team setting and will share roles and responsibilities as assigned by the team leader/manager. ROLE RESPONSIBILITIES The incumbent will be required to complete all processes as detailed in Sample Management’s Standard Operating Procedures. The colleague will perform job responsibilities in compliance with GXP and all other regulatory agency requirements. The candidate will receive samples from clinical trial sites and enter samples into an electronic database management system. Performs sample storage and retrieval using manual freezers and BiOS (automated freezer storage system). Performs manual sample aliquoting and aliquoting using the Hamilton robotic instrument. Ship samples and lab supplies to external and internal testing labs. Assists in the general maintenance of the Hamilton robotic instruments. Participates in the shipment discrepancy resolution process. Completes documentation according to cGMP/GLP and all other regulatory agency requirements and archives documents as per applicable policies. Carries out sample disposal/sample destruction according to regulated policies and procedures Performs other duties as assigned. QUALIFICATIONS Must Have Bachelor of Science Degree or Bachel

ROLE SUMMARY The primary purpose of this job role is to function as a member of the Sample Logistics (SL) operations within Pfizer Vaccine Research and Development (VRD). The incumbent will be responsible for receiving samples from global clinical/study trials according to approved protocols and processes. The individual will participate in all aspects of tracking and documenting the chain of custody of samples. The incumbent’s role will include sample receipt, documentation, storage, tracking, aliquoting, distribution to the testing labs, and sample disposal. The colleague will work in a team setting and will share roles and responsibilities as assigned by the team leader/manager. ROLE RESPONSIBILITIES The incumbent will be required to complete all processes as detailed in Sample Management’s Standard Operating Procedures. The colleague will perform job responsibilities in compliance with GXP and all other regulatory agency requirements. The candidate will receive samples from clinical trial sites and enter samples into an electronic database management system. Performs sample storage and retrieval using manual freezers and BiOS (automated freezer storage system). Performs manual sample aliquoting and aliquoting using the Hamilton robotic instrument. <span style="color:#

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 Specialist/Senior Specialist, Clinical Budgets and Contracts to assist in the financial oversight of Axsome-sponsored clinical trials. Reporting to the Associate Director, Clinical Budgets and Contracts, this role will lead CDA review and processing through execution, develop and negotiate site budgets from study start-up through close-out, and support site payments. 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 the review and execution of CDAs and NMDAs for Clinical and liaise with Legal, as needed Develop clinical trial site budgets for assigned trials and incorporate feedback from the study team Negotiate

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

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/Senior Manager Clinical and PV Quality who will provide Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) oversight of Axsome’s clinical trial activities and related records and processes to assure quality and management in accordance with key global regulations (FDA, Health Canada, EMA and MHRA), ICH guidance (GCP E6, E2 and other relevant guidelines), company processes (such as SOPs) and all other applicable regulations. The Manager/Senior Manager Clinical and PV Quality will manage cross functional relationships with internal and external stakeholders and be the lead Quality GCP and GVP representative on clinical teams for ongoing Axsome-sponsored trials and post-market activities. This position will report to the Senior Vice President, Quality. This role is based at Axsome’s &