Manager, Clinical Study Operations

Responsible for the scientific and clinical oversight of clinical trials in support of the development strategy for programs within the Inflammation & Immunology (I&I) portfolio. As an individual contributor, this role focuses on ensuring data integrity and quality for clinical trials across both early and late-stage development, based on portfolio and resourcing needs. The Senior Manager partners with other clinical and medical colleagues, clinical operations, and other functional lines for the successful implementation and execution of the clinical trial(s) within the assigned program. This role is central to ensuring studies are conducted with the highest scientific and ethical standards. The role is also expected to leverage AI tools and other innovative technologies to improve ways of working, enhance efficiency, reduce work redundancy and improve quality. JOB RESPONSIBILITIES Maintains current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment. Authors and reviews key clinical and regulatory documents including, but not limited to, protocols, study-level informed consent forms (ICFs), Investigator's Brochures (IBs), clinical study reports (CSRs), and regulatory submission components. Leads the clinical data review strategy, including the ongoing review of emerging clinical data for safety and efficacy trends. Presents relevant data to internal teams, governance bodies, and other stakeholders. Collaborates with cross-functional team members (e.g., Clinical Operations, Biostatistics, Regulatory Affairs, Clinical Pharmacology) to ensure trial objectives are met and activities are executed seamlessly. Provides scientific and clinical input for site training materials and supports responses to questions from investigators and site personnel regarding the protocol and study conduct.

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, Statistical Programming to provide programming support for multiple neurology compounds across all phases of development. This role will serve as lead programmer on assigned clinical trials, working closely with Biostatistics and Data Management. The Senior Manager, Statistical Programming will apply programming methodology to summary and analysis of clinical trial data, developing and utilizing SAS programs and macros to create and validate CDISC Study Data Tabulation Model (SDTM) conformed datasets, Analysis Dataset Model (ADaM) datasets, and Tables, Figures, and Listings (TFLs) as scoped in the Statistical Analysis Plan (SAP) for reporting purposes in the Clinical Study Report (CSR). This position will also manage Contract Research Organizations (CROs) providing programming support, and eSubmission package planning, execution, and quality checks of package components for

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 Associate (CTA) that is responsible for supporting the organization to successfully develop and implement clinical trials across its product portfolio and development pipeline. This role provides support to the Clinical Trial Manager (CTM), field based Clinical Research Associates (CRAs), and clinical study sites. This role will be a key study team member responsible for contributing to the life cycle of a clinical trial (all phases) and assure compliance with SOPs, FDA regulations, and ICH/GCP guidelines. 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: &nbsp

LOCATION: Remote with periodic onsite work. The candidate must live within a two hour drive of Austin, TX and be willing to commute to the Austin site a few times a month. POSITION SUMMARY: The Associate Product Manager (APM), Organ Health will partner closely with Product Management and cross-functional teams to support the Organ Health portfolio, including Prospera (donor-derived cell-free DNA testing for transplant) and Renasight (renal genetics testing). The APM will build deep knowledge of both products, their customers, and the operations that deliver them, and will gain exposure to how the products are supported and improved over time through day-to-day support, operational monitoring, and cross-functional collaboration. The role emphasizes strong organization, attention to detail, and follow-through, and will require an effective communicator who can work across Clinical, Laboratory, Operations, Sales, and Business Development teams. PRIMARY RESPONSIBILITIES: Develop working knowledge of the Prospera and Renasight products, including the technology, clinical utility, customer workflows, and operational processes. Serve as an initial point of contact for product and case-related questions from field and internal teams, routing and escalating issues as appropriate. Support clinical study-related activities by partnering with Clinical Operations and Operations teams to address questions and track operational needs over time. Monitor case progress and turnaround time on a regular basis, identify delayed or at-risk cases, and work with Operations and Laboratory partners to move them forward. Provide high-touch support for priority or sensitive cases to help ensure a positive customer experience. Support sustaining product operations, including documentation maintenance and updates, process coordination, and identifying opportunities to improve related processes. Use AI and analytics tools to track, analyze, and report on operational and product performance

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:#