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, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs 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 Monitoring Associate (CMA). Supporting the study Lead Clinical Research Associate (LCRA), the CMA provides administrative and operational support to assist effective site management and oversight of clinical monitoring for assigned protocols. With guidance from the LCRA, the CMA maintains study documentation and tracking tools and supports study activities from start-up through closeout. The CMA also assists with identifying and escalating quality issues related to monitoring activities and partners with the study team to document and implement action plans to address them. 

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: 

• Support the LCRA team, in overseeing clinical monitoring operational execution of assigned clinical studies(s). 

• Assist the LCRA in compiling and analyzing monitoring metrics and study data, documenting results in the relevant trackers, and verifying monitoring compliance to support adequate oversight of clinical monitoring personnel. 

• Provide administrative support and tracking, which may include (but is not limited to) the following: 

• Confirm required CRA study training completion documentation. 

• Perform eTMF reconciliation activities (as assigned). 

• Maintain IP and freezer temperature log trackers. 

• File CRA meeting minutes and agendas in the eTMF. 

• Document oversight follow-up (e.g., track reasons for delayed report drafts and revisions). 

• Verify documents listed as collected in Monitoring Visit Reports (MVRs) are filed in the eTMF. 

• Review and maintain study site monitoring visit trackers. 

• May assist in the development/revision and/or provide input in the development of clinical trial related documents including but not limited to study tools, monitoring tools, presentations, meeting materials, case report forms, informed consents, timelines, clinical monitoring plans, site reference manuals, pharmacy manuals, laboratory manuals, protocols, and training materials. 

• May review clinical monitoring reports to ensure timely completion/finalization and identification of issues. 

• May participate in the Study Oversight meeting(s) with the Study team. 

• Review time sheets, expense reports and invoices. 

• Perform other work-related duties as assigned and under the direction of the Senior Director, Clinical Monitoring or Sr. LCRA. 

Requirements / Qualifications 

• BA/BS or equivalent degree required, preference for a background in a scientific discipline or related healthcare field. 

• Minimum of 1 year of clinical research experience in pharmaceutical, biotechnology, CRO industry. 

• 1 year of clinical monitoring and/or Clinical Trial Associate (CTA) experience preferred. 

• Excellent judgement, and problem-solving skills. 

• Strong organizational, communication, time management and multi-tasking skills. 

• Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles. 

 Experience, Knowledge and Skills 

• Demonstrates core understanding of medical terminology and/or clinical trial activities. 

• Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, required. 

• Experience in CNS preferred. 

• Ability to work on complex and/or multiple projects and exercise critical thinking with minimal supervision. 

• Solid interpersonal skills and communication skills (both written and oral). 

• Excellent team player, willingness and ability to fill functional gaps in a growing organization. 

• Ability to establish priorities, excellent sense of urgency and desire to collaborate (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendors. 

• Self-motivated and adaptable to a dynamic environment. 

• Computer skills including proficiency in the use of Microsoft Office, CTMS, eTMF and eCRF platforms and organization tools. 

• Comfortable multi-tasking in a fast-paced company environment and able to adjust workload based upon changing priorities. 

• Willingness to travel up to 20%. 

 Salary & Benefits

The anticipated salary range for this role is $70,000 - $80,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package. 

Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.  

Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration. 

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, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs 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 Director/Senior Director, Clinical Development to provide leadership across the full lifecycle of CNS programs, from IND through late-stage development and regulatory submission. The Director/Senior Director, Clinical Development will help shape clinical strategy, contribute to protocol design and key regulatory and clinical documents, and serve as a clinical representative with regulators, investigators, and cross-functional partners.

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

• Provide Clinical Development leadership on protocol development, overall study/program, and regulatory submissions 
• Serve as a Clinical Development representative with external stakeholders (e.g., FDA, Principal Investigators, and site staff)  
• Contribute to the development of clinical and regulatory documents, including Clinical Study Reports, Investigator’s Brochures, annual reports (e.g., DSUR), briefing books, and clinical sections of INDs and NDAs  
• Review and contribute to the development of the Statistical Analysis Plan 
• Work in close collaboration with cross-functional departments (e.g., regulatory, clinical operations) to develop and execute program strategies from IND through all phases of clinical development 
• Collaborate with Medical Affairs, HEOR, and the Commercial team to develop the Target Product Profile and overall Value Proposition 
• Develop timelines and integrated program plans for the tracking of product / project deliverables 
• Champion and facilitate program team meetings, cross-functional communication and decision making, ensuring alignment with internal and external stakeholders 
• Partner with the Clinical Operations Study Team to oversee the execution of clinical studies 
• May also serve as lead Medical Monitor on clinical studies (if MD) or may assist Medical Monitor with review of subject eligibility 
• May contribute to pharmacovigilance monitoring AEs, SAEs, and FDA reporting and database reconciliation 
• Participate in clinical data review at the patient level and in aggregate to ensure quality and integrity of study  
• Train clinical study team on therapeutic area, drug product, and protocol, as needed 
• Lead/contribute to publication planning, authoring and presentation of abstracts, posters, slides, and manuscripts 
• Author, review, and revise Standard Operating Procedures (SOPs), as needed 
• Supervise or mentor other Clinical R & D team members 

Requirements / Qualifications

• Post-graduate degree (e.g., PharmD, PhD) or MD required, with at least 10 years of clinical research experience
• Must have at least 4-6 years working in a relevant CNS indication 
• Knowledge of GCP, ICH guidelines and other local guidance, regulation, and codes of practice related to clinical research 
• Ability to work on complex or multiple projects and exercise independent judgment within generally defined practices and policies that lead to obtaining results
• Proven experience in conducting and managing clinical programs (Phase I-IV)
• Demonstrated ability to effectively communicate with and influence individuals at all levels of the organization including situations of conflict resolution and problem solving
• Knowledge of the drug development process with strong understanding of other functions relevant to the position, including clinical operations, biostatistics, and regulatory affairs
• Experience supporting meetings with regulatory agencies (e.g., FDA, EMA, etc.) 
• Willingness to travel as needed
• Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles

Experience and Knowledge:

• Strong time management skills and ability to effectively manage multiple competing priorities
• Strong interpersonal skills and communication skills (both written and oral) 
• Self-motivated, adaptable to a dynamic environment 
• Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities

Salary and Benefits:

The anticipated salary range for this role is $240,000 - $300,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.

Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law. 

Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.

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, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs 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 highly collaborative Medical Writer to draft, edit and submit high quality, medically accurate documents including protocols and clinical study reports. This is a key position within the Clinical Development Group with ample opportunity to make real impact. 

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:  

• Interpret, analyze, and synthesize complex clinical data and develop high-quality strategic scientific documents including protocols, amendments, agency briefing books, clinical study reports, and other documents in support of Clinical Development programs    

• Attend strategic meetings as applicable 

• Closely collaborate with, and apply strategic direction from, project leads and biostatisticians to manage and prioritize assignments and ensure deliverables are completed per time and quality goals 

• Develop documents for assigned programs in compliance with company standard operating procedures (SOPs) 

• Participate in developing timelines, managing review/approval workflows, and QC/publication readiness 

• Lead cross-functional teams to ensure team-wide agreement on documents content 

• Oversee outsourced medical writings projects and the associated vendor(s), as applicable 

• Ensure compliance and accountability for all regulatory documents prepared by the company 

Requirements / Qualifications  

• Advanced scientific or clinical degree (MD, PhD, or PharmD) required and a minimum of 6 years of relevant experience 

• Previous experience with preparation and QC of clinical regulatory documents: Protocols, IBs, CSRs, Module 2 Summary Documents, Clinical Overviews and Agency Briefing Document 

• A strong working knowledge of pharmaceutical drug development and GxP principles 

• Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles 

 Experience, Knowledge and Skills  

• Highly knowledgeable in psychiatric and/or neurological disease areas is a plus 

• Track record of developing high-quality scientific documents 

• Ability to interpret, analyze, and synthesize complex clinical data into compelling and easily understood documents 

• Familiarity with the preparation of Statistical Analysis Plans and document data mapping 

• Experience with programmed outputs of tables, figures and listings for analysis and communication of clinical data 

• Ability to work collaboratively with and coordinate the efforts of team members to resolve comments and complete deliverables 

• Excellent interpersonal skills and judgement that facilitates working with cross-functional executive leadership and maintaining the security of proprietary information 

• Ability to manage/prioritize multiple projects under general supervision while working in a fast-paced environment 

• Flexibility for adapting to rapidly changing deadlines and priorities 

• Must be extremely detail oriented 

• Able to self-manage effort to maintain alignment with strategy and corporate goals 

Salary & Benefits 

The anticipated salary range for this role is $140,000 - $175,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package. 

Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.  

Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration. 

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, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs 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 an intern to support the Pharmacovigilance team. This individual will be responsible for assisting members of the Pharmacovigilance team with a variety of day-to-day tasks, and ongoing projects.   

The Pharmacovigilance Intern will report directly to the Senior Director, PV Operations and will work cross-functionally.  

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: 

• Perform drug information research and /or presentations to extend the understanding of Axsome products  
• Research and understand the disease, symptoms, and treatment of various CNS disorders
• Extensive research of drug addiction vs abuse
• Participate in data analysis in MedDRA coding for ICSR assessment and some potential safety topics analysis for evaluation
• Understand the process of vendor management
• Participate in literature review
• Review applicable Health Authority regulations and ICH guidelines to optimize current Axsome practices aligning with regulatory requirements and industry standards
• Opportunity to initiate or be assigned to pharmacovigilance projects 
• Additional responsibilities as assigned 

Requirements / Qualifications 

• Actively enrolled with a minimum 3.0 GPA in an undergraduate or graduate program with a focus on a medical field e.g., nursing, neuroscience, psychology, psychiatry, biology, pharmacy, etc.  
• A proactive, creative, and entrepreneurial approach to work   
• Interest and/or experience in CNS diseases 
• Excellent oral and written communication skills  
• Demonstrates strong attention to detail   
• Proficient in Microsoft Office Suite (Excel, Word, PowerPoint) 
• Organizational and critical thinking skills 
• Strong interpersonal skills and the ability to work well in a team environment 
• Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles 

Experience and Knowledge 

• Experience and knowledge in literature screening for potential literature case or MOA of potential drug adverse reaction 
• Interest in Pharmaceutical/Life Sciences industry a plus
• Accomplished background demonstrating teamwork, creativity, leadership, good judgement, and delivering results 

Additional Details

The anticipated hourly rate for this role is $18-$25/hour. The salary offer will be based on a variety of factors, including experience, qualifications, and internal equity. 

This is a full-time and temporary role beginning in June and concluding in August. Final dates will be confirmed this spring. Successful candidates will be compensated at an hourly rate for the duration of the internship. Interns will work a maximum of 40 hours a week. 

Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law. 

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, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs 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, Data Management to be responsible for conducting and overseeing all data management aspects for assigned clinical program(s) in compliance with ICH GCP, regulatory guidelines/standards and applicable SOPs. Tasks include collaborating cross-functionally with study teams, providing DM expertise and conducting all data management activities, overseeing vendors, timelines, costs, resources, and key project deliverables.   

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: 

• Data management oversight of multiple clinical development programs in addition to serving as the lead clinical data manager on designated programs as needed  

• Responsible for data related vendor selection and oversight activities across multiple clinical development programs  

• Oversee the planning and management of Data Management costs and timelines  

• Represent data management function on the clinical and cross-functional team meetings ensuring aligned expectations between all parties, including outside vendors.  

• Ensure achievement of major data management deliverables and milestones in coordination with other functions including Clinical Operations, Safety, Statistics, etc.  

• Responsible for drafting safety and other customized data listings/metrics/reports to drive activities such as medical reviews, clinical reviews and risk-based monitoring  

• Participate and represent data management function in during audits and inspections as requested.  

• Author, review, and revise Standard Operating Procedures (SOPs)  

• Draft/review Data Management Plans, data entry guidelines, data management reports and other documents   

• Lead the development and user acceptance testing of Case Report Forms (CRFs) and edit check specifications per protocol, across the lifecycle of the study   

• Manage external data transfers, reconciliations, and system integrations  

• Lead the process of cleaning databases by performing a review of clinical trial data through EDC or data listings  

• Generate queries to appropriate internal or external personnel (e.g. - investigational sites, vendors, Clinical Research Associates) to resolve problematic data identified during every aspect of the data management process  

• Review responses to queries for appropriateness and resolution to ensure high data quality  

• Train team members on Axsome procedures, study specific handling and management of Data Management systems   

• May also act to supervise and mentor data management staff  

• Ensure archival of all Data Management Trial Master File (TMF) documents 

 Requirements / Qualifications 

• Bachelor’s degree required. Preference to candidates with a scientific background (RN, MS, MD, PharmD, PhD or similar)  

• Minimum of 4 - 7 years data management experience in a biotech/pharmaceutical company or clinical research organization (CRO)  

• Thorough understanding of FDA, GCP and ICH guidelines  

• Strong knowledge of EDC and/or systems design (i.e., Merative Zelta (IBM Clinical), Veeva, Medrio, Rave, etc.), IRT/IWRS and data warehouse technologies as applied to clinical trials  

• Strong working knowledge of (e)CRF design and data management functions/activities as applied to standards library development and maintenance  

• Good working knowledge of CDISC standards and experience implementing standards preferred  

• Advanced knowledge of Excel  

• Good working knowledge of general statistical programming processes and practices. Advanced knowledge of medical terminology, medical coding, laboratory reference ranges, and clinical procedures 

• Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles 

 Experience, Knowledge and Skills 

• Exhibits initiative, strong problem solving and leadership skills  

• Ability to handle multiple programs simultaneously with strong project management capabilities  

• Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities  

• Excellent team player: willingness and ability to fill functional gaps in a small but growing organization  

• Preference to energetic candidates with a desire to think “outside the box”   

• Strong attention to detail and excellent organization skills  

• Strong interpersonal skills and communication skills (both written and oral)  

• Embody a culture of continual improvement and innovation; promote knowledge sharing 

 Salary & Benefits 

The anticipated salary range for this role is $125,000 - $140,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package. 

Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.  

Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.