Current Opportunities

JOB SUMMARY

Axsome Therapeutics is seeking an Associate Director, Clinical Operations to lead one, or more, of our clinical studies. The position will lead clinical operations for assigned clinical program(s) including oversight of timelines, budgets, resources, clinical trial sites, vendors and key project deliverables. This role also manages, mentors, and/or provides professional development guidance to Clinical Trial Managers (CTMs), Clinical Research Associates (CRAs), and Clinical Trial Associates (CTAs).

This is a hybrid role based at Axsome’s HQ in New York City.

JOB RESPONSIBILITIES

• Direct operational oversight of one or more clinical development programs which can include but is not limited to: planning and initiating clinical trials including protocol development; evaluation of investigators; evaluation, selection, and training of vendors; review and negotiation of study budgets; and CRF design coordination.
• Lead cross functional teams at the program and study level.
• Ensure clinical studies/programs are executed within projected budget, on time and with quality.
• Guide study teams in vendor selection and management throughout the life of all assigned clinical projects.
• Responsible for development of recruitment strategies, assessing operational feasibility and implementation of activities to increase patient enrollment.
• Manage and communicate to senior management overall clinical operations plan for studies including timelines, internal and external resources/costs, and key deliverables.
• Develop and manage study specific budgets and timelines.
• Identify and provide solutions and direction related to key cross-functional, sponsor-site, and sponsor-vendor clinical trial issues.
• Author, review and revise Standard Operating Procedures (SOPs).
• Hire, supervise and train operations personnel (CTM, CRAs, and/or CTAs) and takes ownership of the quality of assigned clinical programs and deliverables. Set annual goals, objectives and development plans for staff, provide performance feedback and conduct performance evaluations.
• Additional responsibilities as assigned.

QUALIFICATIONS

• Bachelor’s Degree required. Advanced Degree preferred in life sciences, health care or related discipline.
• At least 7 years clinical research experience in a biotech/pharmaceutical company or clinical research organization (CRO). At least 1 year clinical research experience at a biotech/pharmaceutical company is required. Preference to candidates with prior small company experience.  
• Thorough understanding of FDA, GCP and ICH guidelines.
• Must have strong organization skills, be a team player yet function independently and comfortable interacting with KOLs, vendors and investigational sites.
• Exhibits strong presentation skills.
• 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”.
• Must be able to work in the NYC office.
• Willingness to travel as needed, up to 20%.

SALARY & BENEFITS

The anticipated salary range for this role is $130,000 - $160,000. 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.

JOB SUMMARY

Axsome Therapeutics is currently seeking an Associate Director of Commercial Data Operations to manage  commercial data essential to support our commercial strategy and operations. Focus areas include data governance & stewardship, data warehouse enhancements and project management to implement various data integrations needed to support successful commercial launches. This critical role will report directly to Vice President of Commercial Operations.

This is a hybrid role based at Axsome's HQ in New York City. 

JOB RESPONSIBILITIES

• Primary point of contact for commercial operations for data management
• Lead data strategy, data quality and business rules management, data stewardship, data catalog and lineage, data mart creation
• Ensure data is clean, correct, current, consistent, and complete
• Take ownership of creating a unified commercial data warehouse and being able to integrate and connect all the data sources to maximize value of data
• Partner with IT to develop data architecture and enterprise analytics work bench, leveraging the cutting-edge big data technologies
• Collaborate with external and internal partners to enable analytics and reporting through management of commercial data warehouse, business intelligence tools and data integrations
• Manage commercial data and processes within Veeva product ecosystem (Nitro, Network, Open Data, Vault and other Veeva products)
• Enhance the value of the commercial data purchases by enhancing them and integrating them to create analytics ready databases.
• Tailor the data and systems solutions to match the changing needs of the commercial organization to adapt to a digital centric commercialization approach
• Develop a commercial data roadmap in collaboration with internal and external partners.
• Stay abreast of best practices and new technologies in the data and analytics space
• Additional responsibilities as assigned

QUALIFICATIONS

• Bachelor’s Degree required; Master’s Degree or MBA preferred
• 5+ years of data management experience in the pharmaceutical or biotech industry (which may include work as a consultant or supplier to the industry)
• Experience in CNS therapeutic area is preferred
• Demonstrated knowledge of business operations and ability to identify and investigate operational needs, and opportunities, and leads the implementation of improvements within area of responsibility
• Must have deep understanding and knowledge of data management tools and processes, business intelligence, and integrated data warehousing solution designing.
• Strong analytical and project management skills required; including a thorough understanding of how to interpret customer business needs and translate them into application and operational requirements and deliver optimized technical solution focused on business process.
• Proficient in SQL, pharma datasets, MS- Office (esp. Excel, Vision), data editing software and other data management tools
• Advanced level experience with Database systems and tools such as Tableau, Qlik View, SQL, Veeva Network, and Veeva CRM
• Experience developing complete data warehouse and customer master for the pharmaceutical vertical market
• Ability to work creatively and analytically with confidence in a problem-solving environment
• Strong team player with ability to manage conflicting priorities
• Demonstrates ability to work with many cross-functional partners
• Ability to understand and influence decisions
• Ability to interact and communicate with all levels in the organization
• Self-starter, proactive, actively participates and self-motivated

SALARY & BENEFITS

The anticipated salary range for this role is $130,000 - $165,000. 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.

JOB SUMMARY

Axsome Therapeutics is seeking an Associate Director/Director, Biostatistics, Medical and Real-World Data to serve as the technical lead for the statistical design and analyses of clinical trial data beyond the primary endpoints, The purpose is to support evidence generation to characterize value and differentiation, Quality of Life outcomes, Health Technology Assessments (HTAs), understanding patients, patient behaviors, diseases and their burden, and value of therapies in the real world, market access discussion through analytics. This role will primarily be supporting Medical Affairs, Health Economics Outcomes Research (HEOR), and Clinical Development colleagues in the development of technical reports, presentations, posters, manuscripts, and other key scientific documents for products across the portfolio.

This is a hybrid role based at Axsome’s HQ in New York City.

JOB RESPONSIBILITIES

• Support the statistical design and analyses of clinical trials data beyond the primary endpoints, such as exploratory subgroup analyses, and various types of real-world evidence (RWE), including claims datasets, electronic health records (EHRs), healthcare utilization data sets, etc.
• Technical lead supporting various post-hoc and real-world data analyses studies including study design concept, developing an analyses plan and carrying-out or leading the study analyses for various products across the portfolio
• Work closely with Medical Affairs, HEOR, and Clinical Development colleagues to provide statistical analyses and create statistical/programmatic outputs to be used in final reports, publications, posters, manuscripts, etc.
• Liaise with internal teams and external clinicians to generate and QC outputs for publications, review publications to ensure accuracy, quality and soundness of statistical methodologies; coordinate, oversee and ensure quality delivery from vendors and their resources
• Lead, design, conduct statistical analysis, interpretation and presentation of analyses results to stakeholders and leadership
• Provide technical direction and guidance on research, development, implementation, and evaluation of statistical methodologies
• Provide oversight of concept design, Statistical Analysis Plan (SAP) development and ensure appropriateness of study/experiment/survey design, data collection, Patient Reported Outcomes (PRO) design/analyses with appropriate sample size and statistical methodologies
• Manage project analysis plans, including table, figure, listing shells, and review reports
• Work with external vendors supporting various project-specific work
• Identify statistical research areas that merit investigation, develop new hypotheses and methodological approaches
• Develop internal processes and SOPs for the conduct and data management of exploratory and real-world statistical analyses
• Additional responsibilities as assigned

QUALIFICATIONS

• Master’s degree or PhD in statistics, biostatistics, epidemiology, or related discipline
• At least 5 years’ experience in statistics in a biotech/pharmaceutical/medical device company or clinical research organization (CRO)
• Experience with CNS, psychiatry, or sleep medicine therapeutic areas preferred but not required
• Strong statistical background demonstrated by serving in primary roles as statistician or lead statistician in trial design and analyses
• At least 3+ years’ experience in real-world evidence, HEOR, or observational study statistics and data analytics in a biotech/pharmaceutical/medical device company or clinical research organization (CRO)
• Experienced with statistical programming in SAS, R or Python
• Extensive knowledge and demonstrated experience with a variety of real world evidence (RWE) sources and observational research study design
• Demonstrated ability to communicate complex ideas and statistical results to diverse audiences ranging from executives to technical programmers
• Experience supporting development of RWE analytics portfolio spanning multiple products
• Strong working knowledge of CDISC standards, including SDTM and ADaM
• Ability to handle multiple programs simultaneously
• Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities
• Preference to energetic candidates with a desire to think “outside the box”

SALARY & BENEFITS
The anticipated salary range for this role is $150,000 - $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.

JOB SUMMARY

Axsome Therapeutics is seeking a Clinical Research Scientist or Sr. Clinical Research Scientist (based on experience) that reports to the Clinical R&D function, serves as a critical asset to the Clinical Lead and supports the design and delivery of our clinical trials.  The CRS is responsible for the implementation, planning and execution of assigned clinical trial activities and serves as the Clinical Trial Lead for multiple studies. The Clinical Research Scientist will independently lead, plan and execute trial and compound level activities. 

This is a hybrid role based at Axsome’s HQ in New York City.

JOB RESPONSIBILITIES

• Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
• Plan and lead the implementation all study startup/conduct/close-out activities as applicable
• Evaluate innovative trial designs (collaboration with Medical Monitor/Clinical R & D Lead)
• Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality
• Co-lead study team meetings in partnership with Clinical Operations and collaborates with cross-functional study team members (e.g., Regulatory Affairs, Safety, Data Management).
• Partner with the Clinical Trial Manager and Study Director to support the overall execution of a clinical studies.
• Perform regular data reviews to identify trends.
• Support medical data review and medical coding review.
• Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on study committee (e.g., DMC) activities
• Draft/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
• Collaborate and serve as primary liaison between external partners for scientific advice
• Facilitate development of case report forms.
• Support SAE process, query generation, narrative development and review.
• Support labelling, distribution, and overall accountability of Clinical trial material (CTM) for the clinical study, as needed.
• Support the review and revision of Standard Operating Procedures (SOPs).
• Assist in the preparation of abstracts, poster presentations, slides, and manuscripts of clinical study findings.
• Attend relevant therapeutic area conferences/meetings based on assignments and engages KOLs.
• Support review of proposed investigator-sponsored research (ISR).

QUALIFICATIONS/REQUIREMENTS

• Advanced degree (Pharm.D., MPH, PhD, MS) with at least 5 (Assoc. Dir.) or 8 (Dir.) years of clinical development experience at a pharmaceutical company
• Experience writing and reviewing clinical documents (eg, protocols, CSRs, IBs, DSURs). Experience with regulatory documents (INDs, briefing books, NDAs)
• Strong analytical skills with excellent communication (both oral and written)
• Ability to assimilate technical information quickly
• Routinely takes initiative
• Detail-oriented
• Strong sense of teamwork; ability to lead team activities
• Proficient in Medical Terminology and medical writing skills
• Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile)
• Proficient critical thinking, problem solving, decision making skills
• Thorough understanding of FDA, GCP and ICH guidelines
• 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”
• Proficiency with MS Office suite, Electronic Data Capture, and other reporting tools
• Willingness to travel as needed, up to 20%
• Ability to work on site Monday, Tuesday and Thursday

SALARY & BENEFITS

The anticipated salary range for this role is $123,000 - $145,000. 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.

JOB SUMMARY
The Clinical Trial Associate 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, the field based CRAs, and the investigational sites.  This role will be a key study team member responsible for multiple clinical trials (all phases) and assure compliance with SOPs, FDA regulations, GCP and ICH guidelines.

This is a hybrid role based at Axsome’s HQ in New York City.

JOB RESPONSIBILITIES

• Create and maintain study trackers (e.g., contact lists, study status trackers, enrollment)
• Ensure accurate and up to date information in clinical trial management system (CTMS)
• Review and maintain documents in the Trial Master File (TMF)
• Assist clinical team during all phases of clinical study activities (feasibility, start-up, maintenance, and close-out)
• Collect and review essential regulatory documents prior to site initiation/study drug release
• Submission and tracking of documents to central IRB
• Distribute materials to study sites, as directed
• Participate in study team and vendor meetings
• Schedule meetings and draft meeting minutes/distribute final minutes, as needed
• Assist the project team in preparation and distribution of study documents (e.g, consent form, study reference manual, regulatory binder, patient recruitment material, and newsletters)
• Support field-based clinical study monitors
• Assist with quality review of clinical data, as needed
• Assist project team with Investigator Meeting coordination and preparation and draft meeting minutes
• Additional responsibilities as required

QUALIFICATIONS

• Bachelor's degree required. Preference to candidates with a life science or nursing degree
• Prior experience in clinical research
• Must have good organization skills, be a team player, function independently, and be able to interact comfortably with company personnel as well as vendors and investigational sites
• Computer proficiency, GCP, and basic clinical research terminology knowledge required
• 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”

SALARY & BENEFITS

The anticipated salary range for this role is $60,000 - $66,000. 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.

JOB SUMMARY

Axsome Therapeutics is seeking a 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 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 is a hybrid role based at Axsome’s HQ in New York City.

JOB RESPONSIBILITIES

• Responsible for leading all operational aspects and progress of clinical trial which can include but is not limited to: study planning activities; study execution including ongoing tracking of all applicable performance metrics; and quality indicators
• Serve as an escalation point and resource for study team and investigative sites
• Facilitate and review the site feasibility process and oversees the site selection processes
• Oversee subject recruitment / retention strategy and related initiatives
• Provide operational input for study documents such as synopsis, and protocol, and develops/approves ICFs, CRFs, CRF Completion Guidelines, study plans, including Clinical Monitoring Plan, Protocol Deviation Plan, Risk Management Plan, etc.
• Develop protocol training materials for CRAs and site facing materials for SEVs, SIVs and ad-hoc training
• Responsible for oversight of study teams in review of clinical data in conjunction with Data Management; provides guidance on issues / queries as needed and implements risk management concepts as appropriate
• In conjunction with the Lead CRA, this position will be responsible for motivating and leading the assigned clinical monitoring team to deliver on study timelines and milestone deliverables
• Oversee monitoring visit schedule to ensure compliance with frequency set forth in CMP
• Review site monitoring visit reports for clarity and completeness and escalates issues identified
• Participate in clinical vendor selection process as a part of outsourcing activities
• Assist in the review and approval of vendor and site budgets along with the study director
• Provide oversight for all clinical vendor activities (e.g., specifications development, UATs, issues escalations, KPIs)
• Work closely with QA to drive CAPA review, implementation, and completion
• Oversee the eTMF set-up, ongoing quality review, and final reconciliation of study documents
• Ensure that all aspects of GCP compliance and audit/inspection readiness are maintained throughout trial conduct
• Create, manage, measure, and report timelines for milestone deliverables
• Proactively manage and identify potential study issues and risks as well as recommend and implement solutions with key internal / external stakeholders
• Lead internal team meetings, and other trial-specific meetings
• Participate in the development, review, and implementation of departmental SOPs, initiatives, and processes
• May conduct Site Evaluation visits (SEVs) and Site Initiation Visits (SIVs)
• Review and approve vendor invoices for all clinical trial vendors including investigative sites
• Additional responsibilities as assigned

QUALIFICATIONS

• Bachelor’s degree required; preference to candidates with a scientific background
• At least 5 years clinical research experience in a biotech/pharmaceutical company or clinical research organization (CRO)
• Preference to candidates with prior small company experience and 1+ years management experience
• Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations / ICH / GCP guidelines, is required
• Ability to work on complex or multiple projects and exercise independent judgment within generally defined practices and policies that lead to obtaining results
• Strong attention to detail, time management and excellent organizational skills
• Strong interpersonal skills and communication skills (both written and oral)
• Ability to problem solve, delegate appropriate tasks, work within a team environment and mentor junior team members such as CTAs/CRAs.
• Excellent sense of urgency to deliver at/surpass study conduct targets
• Strong leadership skills, 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
• Preference to energetic candidates with a desire to think “outside the box”
• Willingness to travel as needed, up to 20%

SALARY & BENEFITS

The anticipated salary range for this role is $100,000 - $125,000. 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.

JOB SUMMARY

Axsome Therapeutics is seeking a Director/Senior Director, Clinical Operations to lead clinical operations for assigned clinical program(s) including oversight of timelines, budgets, resources, clinical trial sites, vendors and key project deliverables. This position manages, mentors, and provides professional development guidance to Clinical Trial Managers (CTMs), Clinical Research Associates (CRAs), and Clinical Trial Associates (CTAs). This role acts as the Study Director on individual studies. The Senior/Director may also act as a line manager for specific individual roles such as CTAs.

This is a hybrid role based at Axsome’s HQ in New York City.

JOB RESPONSIBILITIES

• Direct operational oversight of one or more clinical development programs which can include but is not limited to: planning and initiating clinical trials including protocol development; evaluation of investigators; evaluation, selection, and training of vendors; review and negotiation of study budgets; and CRF design coordination.
• Lead cross functional teams at the program and study levels.
• Ensure clinical studies/programs are executed within projected budget, on time and with quality.
• Guide study teams in vendor selection and management throughout the life of all assigned clinical projects.
• Responsible for development of recruitment strategies, assessing operational feasibility, and implementation of activities to increase patient enrollment.
• Manage and communicate to senior management overall clinical operations plan for studies including timelines, internal and external resources/costs, and key deliverables.
• Plan, convene, run and present at investigator meetings and advisory boards.
• Identify and communicate with therapeutic thought leaders for feedback on study protocols, development plans, publications, etc.
• Develop and manage study specific budgets and timelines.
• Identify and provide solutions and direction related to key cross-functional, sponsor-site, and sponsor-vendor clinical trial issues.
• Author, review and revise Clinical Operations Standard Operating Procedures (SOPs).
• Hire, supervise and train operations personnel (CTM, CRAs, and/or CTAs) and take ownership of the quality of assigned clinical programs and deliverables. Set annual goals, objectives and development plans for staff, provide performance feedback and conduct performance evaluations.
• Additional responsibilities as assigned.

QUALIFICATIONS

• Bachelor’s Degree required. Advanced Degree in life sciences, health care or related discipline. Preference to candidates with a scientific background.
• At least 10 years clinical research experience in a biotech/pharmaceutical company or clinical research organization (CRO). At least 1 year clinical research experience at a biotech/pharmaceutical company is required. Preference to candidates with prior small company experience.  
• Thorough understanding of FDA, GCP and ICH guidelines.
• Must have strong organization skills, be a team player yet function independently and comfortable interacting with KOLs, vendors and investigational sites.
• Adept at developing clinical study patient recruitment strategies.
• Exhibits strong presentation skills.
• 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”.
• Ability to work on site Monday, Tuesday and Thursday
• Willingness to travel as needed, up to 20%.

SALARY & BENEFITS

The anticipated salary range for this role is $160,000 - $215,000. 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.

JOB SUMMARY
Axsome Therapeutics is currently seeking a Director, Government and Regional Accounts to lead payer engagements and drive broad access for the company’s innovative medicines at launch and beyond.

The Director, Government and Regional Accounts is responsible for developing and maintaining strong relationships at multiple Regional Payer and PBM accounts. This role requires the ability to understand and influence multiple stakeholders including Pharmacy Director, Medical Director, Clinical Pharmacy/Finance Directors and P&T members with the end goal of rapid formulary inclusion of launch products, ensuring easy and affordable access for patients.

The Director, Government and Regional Accounts will develop and execute account specific strategies for regional payer accounts and PBMs, primarily within the Medicaid channel with potential to expand into commercial over time.  Internally, this role will collaborate cross functionally with Sales, Marketing, HEOR, Medical and Pricing & Contracting to ensure a balance between affordable and easy access for patients while meeting the Net Sales goals of the company. The Director, Government and Regional Accounts plays a critical role in the delivery of product value proposition that demonstrates the clinical and economic value of Axsome Therapeutics’ CNS products. This role reports directly to the Senior Director of Market Access. 

This field-based position for the Mid-Atlantic & South East region.

JOB RESPONSIBILITIES

• Ensure disciplined and effective communication with key payer stakeholders and decision makers
• Understand dynamics of the PBM/state Medicaid relationships, Managed Medicaid plans, and key decision makers
• Attend P&T meetings and Learn P&T Committee dynamics and level of influence each has over decisions (i.e. statewide PDL, exemption state, etc.)
• Network across the industry and each account (state Medicaid, Managed Medicaid plans, PBMs) to develop rapport with key decision makers so in place when needed
• Execute the payer engagement strategy and leverage Payer Value Proposition to obtain appropriate access/formulary position among target accounts
• Profile key payer accounts to assess formulary review process, formulary coverage policies, utilization management deployed for the applicable therapeutic areas, and geographic coverage areas
• Identify and address potential barriers to access proactively to ensure launch product is well positioned for formulary and P&T reviews
• Identify competitive threats and develop strategies to ensure optimal coverage for Axsome Therapeutics’ portfolio of products
• Lead pull-though initiatives that capitalize on formulary wins and lead push-though efforts in areas with access challenges
• Ensure compliance with Axsome Therapeutics’ corporate policies and procedures and U.S. healthcare laws and regulations
• Additional responsibilities as assigned

QUALIFICATIONS

• Bachelor’s Degree in business, marketing, economics, or health sciences
• Minimum 1-3 years of people leadership, ideally in field based Sales and/or Market Access
• Minimum 3 years of successful Payer Account Management experience, ideally inclusive of the Medicaid channel
• Demonstrated experience gaining formulary access for a launch product at multiple regional and Medicaid payer accounts and PBMs
• Previous experience at a small biopharmaceutical company
• Negotiation experience, preferably in competitive primary care therapeutic areas
• Analytical mindset and history of leveraging HEOR data to articulate a value story that ensures rapid formulary coverage of launch products
• A problem-solving mindset with demonstrated “lean-forward” approach and ability to think critically
• Strong understanding of the payer landscape and how payer decision making impacts providers and their patients
• Excellent oral, written and presentation skills with ability to influence decision makers and explain complex concepts clearly to a variety of audiences
• Previous product launch experience, preferably in the CNS space and Medicaid channel
• Familiarity with current legal and regulatory landscape pertinent to the industry

SALARY & BENEFITS

The anticipated salary range for this role is $200,000-$225,000. 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.

JOB SUMMARY
Axsome Therapeutics is currently seeking a Director, Government and Regional Accounts to lead payer engagements and drive broad access for the company’s innovative medicines at launch and beyond.

The Director, Government and Regional Accounts is responsible for developing and maintaining strong relationships at multiple Regional Payer and PBM accounts. This role requires the ability to understand and influence multiple stakeholders including Pharmacy Director, Medical Director, Clinical Pharmacy/Finance Directors and P&T members with the end goal of rapid formulary inclusion of launch products, ensuring easy and affordable access for patients.

The Director, Government and Regional Accounts will develop and execute account specific strategies for regional payer accounts and PBMs, primarily within the Medicaid channel with potential to expand into commercial over time.  Internally, this role will collaborate cross functionally with Sales, Marketing, HEOR, Medical and Pricing & Contracting to ensure a balance between affordable and easy access for patients while meeting the Net Sales goals of the company. The Director, Government and Regional Accounts plays a critical role in the delivery of product value proposition that demonstrates the clinical and economic value of Axsome Therapeutics’ CNS products. This role reports directly to the Senior Director of Market Access. 

JOB RESPONSIBILITIES

• Ensure disciplined and effective communication with key payer stakeholders and decision makers
• Understand dynamics of the PBM/state Medicaid relationships, Managed Medicaid plans, and key decision makers
• Attend P&T meetings and Learn P&T Committee dynamics and level of influence each has over decisions (i.e. statewide PDL, exemption state, etc.)
• Network across the industry and each account (state Medicaid, Managed Medicaid plans, PBMs) to develop rapport with key decision makers so in place when needed
• Execute the payer engagement strategy and leverage Payer Value Proposition to obtain appropriate access/formulary position among target accounts
• Profile key payer accounts to assess formulary review process, formulary coverage policies, utilization management deployed for the applicable therapeutic areas, and geographic coverage areas
• Identify and address potential barriers to access proactively to ensure launch product is well positioned for formulary and P&T reviews
• Identify competitive threats and develop strategies to ensure optimal coverage for Axsome Therapeutics’ portfolio of products
• Lead pull-though initiatives that capitalize on formulary wins and lead push-though efforts in areas with access challenges
• Ensure compliance with Axsome Therapeutics’ corporate policies and procedures and U.S. healthcare laws and regulations
• Additional responsibilities as assigned

QUALIFICATIONS

• Bachelor’s Degree in business, marketing, economics, or health sciences
• Minimum 1-3 years of people leadership, ideally in field based Sales and/or Market Access
• Minimum 3 years of successful Payer Account Management experience, ideally inclusive of the Medicaid channel
• Demonstrated experience gaining formulary access for a launch product at multiple regional and Medicaid payer accounts and PBMs
• Previous experience at a small biopharmaceutical company
• Negotiation experience, preferably in competitive primary care therapeutic areas
• Analytical mindset and history of leveraging HEOR data to articulate a value story that ensures rapid formulary coverage of launch products
• A problem-solving mindset with demonstrated “lean-forward” approach and ability to think critically
• Strong understanding of the payer landscape and how payer decision making impacts providers and their patients
• Excellent oral, written and presentation skills with ability to influence decision makers and explain complex concepts clearly to a variety of audiences
• Previous product launch experience, preferably in the CNS space and Medicaid channel
• Familiarity with current legal and regulatory landscape pertinent to the industry

SALARY & BENEFITS

The anticipated salary range for this role is $200,000-$225,000. 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.

JOB SUMMARY
Axsome Therapeutics is currently seeking a Director, Government and Regional Accounts to lead payer engagements and drive broad access for the company’s innovative medicines at launch and beyond.

The Director, Government and Regional Accounts is responsible for developing and maintaining strong relationships at multiple Regional Payer and PBM accounts. This role requires the ability to understand and influence multiple stakeholders including Pharmacy Director, Medical Director, Clinical Pharmacy/Finance Directors and P&T members with the end goal of rapid formulary inclusion of launch products, ensuring easy and affordable access for patients.

The Director, Government and Regional Accounts will develop and execute account specific strategies for regional payer accounts and PBMs, primarily within the Medicaid channel with potential to expand into commercial over time.  Internally, this role will collaborate cross functionally with Sales, Marketing, HEOR, Medical and Pricing & Contracting to ensure a balance between affordable and easy access for patients while meeting the Net Sales goals of the company. The Director, Government and Regional Accounts plays a critical role in the delivery of product value proposition that demonstrates the clinical and economic value of Axsome Therapeutics’ CNS products. This role reports directly to the Senior Director of Market Access. 

JOB RESPONSIBILITIES

• Ensure disciplined and effective communication with key payer stakeholders and decision makers
• Understand dynamics of the PBM/state Medicaid relationships, Managed Medicaid plans, and key decision makers
• Attend P&T meetings and Learn P&T Committee dynamics and level of influence each has over decisions (i.e. statewide PDL, exemption state, etc.)
• Network across the industry and each account (state Medicaid, Managed Medicaid plans, PBMs) to develop rapport with key decision makers so in place when needed
• Execute the payer engagement strategy and leverage Payer Value Proposition to obtain appropriate access/formulary position among target accounts
• Profile key payer accounts to assess formulary review process, formulary coverage policies, utilization management deployed for the applicable therapeutic areas, and geographic coverage areas
• Identify and address potential barriers to access proactively to ensure launch product is well positioned for formulary and P&T reviews
• Identify competitive threats and develop strategies to ensure optimal coverage for Axsome Therapeutics’ portfolio of products
• Lead pull-though initiatives that capitalize on formulary wins and lead push-though efforts in areas with access challenges
• Ensure compliance with Axsome Therapeutics’ corporate policies and procedures and U.S. healthcare laws and regulations
• Additional responsibilities as assigned

QUALIFICATIONS

• Bachelor’s Degree in business, marketing, economics, or health sciences
• Minimum 1-3 years of people leadership, ideally in field based Sales and/or Market Access
• Minimum 3 years of successful Payer Account Management experience, ideally inclusive of the Medicaid channel
• Demonstrated experience gaining formulary access for a launch product at multiple regional and Medicaid payer accounts and PBMs
• Previous experience at a small biopharmaceutical company
• Negotiation experience, preferably in competitive primary care therapeutic areas
• Analytical mindset and history of leveraging HEOR data to articulate a value story that ensures rapid formulary coverage of launch products
• A problem-solving mindset with demonstrated “lean-forward” approach and ability to think critically
• Strong understanding of the payer landscape and how payer decision making impacts providers and their patients
• Excellent oral, written and presentation skills with ability to influence decision makers and explain complex concepts clearly to a variety of audiences
• Previous product launch experience, preferably in the CNS space and Medicaid channel
• Familiarity with current legal and regulatory landscape pertinent to the industry

SALARY & BENEFITS

The anticipated salary range for this role is $200,000-$225,000. 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.

JOB SUMMARY

Axsome Therapeutics is seeking a Director, Intellectual Property. The Director, Intellectual Property will help build Axsome’s intellectual property portfolio and contribute to its patent and trademark strategies. Successful candidates should have demonstrable skills in evaluating and identifying new discoveries, leading the effort from initial filings to worldwide patent issuance, and supporting R&D efforts. Candidates will have a strong understanding of U.S. and preferably foreign patent systems, including patent filing and prosecution processes.  Reporting to Axsome’s General Counsel, the Director, Intellectual Property, will support a number of key cross-functional projects.

This is a hybrid role based at Axsome’s HQ in New York City.

JOB RESPONSIBILITIES

• Works closely with external counsel to manage prosecution of a portfolio of patents and trademarks and applications in the U.S. and globally, including patent term extensions, and SPCs.
  
  
• Provides legal support, as needed in negotiating, drafting and reviewing licensing, co-promotion, co-development, co-marketing, and clinical trial collaboration agreements.
  
  
• Works closely with development teams to monitor results, new uses, etc. arising during research and development of products and to manage disclosures and publications of such findings to ensure that all appropriate patentable matter is protected in a timely manner by the filing and prosecution of patent application(s).
  
  
• Works closely with teams for pipeline and marketed products, in order to manage/process patent term extensions, Orange Book listings, claims for regulatory exclusivity, as well as ensure that any new patent protections available are obtained for new uses, different results, etc.
  
  
• Monitors current developments in several key legal areas and provides Executive Leadership Team with updates regarding same.
  
  
• Recommends strategic policies and procedures to maximize IP protection in view of new legal and regulatory developments.
  
  
• Develops IP policy, procedure, and training on IP law and topics.
  
  
• Other duties as assigned.

QUALIFICATIONS

• 5+ years relevant experience.
• D. + advanced degree in relevant scientific field.
• Ability to work on site Monday, Tuesday and Thursday

SALARY & BENEFITS

The anticipated salary range for this role is $230,000 - $260,000. 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.

JOB SUMMARY

Axsome Therapeutics is currently searching for a Manager, Commercial Sales Operations to support our commercial product launches. The Commercial Sales Operations Manager is responsible for a variety of coordination and execution of key sales operations functions. Key responsibilities include 1) Sample program management, 2) Management of HCP engagement plans to ensure they are effective and efficient, 3) Ensure that field teams maximize the use of data and technology to deliver results and 4) Manage field related compliance operations. This role will report directly to Director of Commercial Sales Operations.

This is a hybrid role based at Axsome’s HQ in New York City.

JOB RESPONSIBILITIES

• Work with cross-functional team to optimize and manage sample program
• Manage territory alignment process and changes for Field
• Identifies relevant field KPI’s and works with field leadership to put in place relevant reports/dashboards to understand and effectively manage opportunities
• Create ad hoc analysis/reports to identify opportunities for Field execution based on CRM engagement data and secondary data sources (IQVIA/Symphony)
• Collaborate with broader Commercial Operations team to review data, improve existing processes, and on new projects
• Act as a liaison with Corporate Compliance to ensure all systems support our field representatives and meet compliance requirements
• Leverage CRM/SFA systems to full capabilities and enhance to support the field
• Support Sales leadership in the organization and coordination of National Sales meetings, Manager Meetings, and POA meetings
• Manage the auto/fleet program for field-based personnel
• Additional responsibilities as assigned

QUALIFICATIONS

• Bachelor’s Degree required
• 4+ years of sales operations experience in the pharmaceutical or biotech industry (which may include work as a consultant or supplier to the industry)
• Demonstrated knowledge of sales operations and ability to identify and investigate operational needs, and opportunities, and leads the implementation of improvements within area of responsibility
• Understand key pharmaceutical data sources (e.g. IQVIA, Symphony) and data structures to produce insights
• Ability to operate in ambiguous situations and determine focused objectives and a clear path forward in the face of open questions
• Advanced knowledge of MS Office (Excel, PowerPoint, Word) is required
• Strong team player with ability to manage conflicting priorities
• Demonstrated ability to work with many cross-functional partners
• Ability to interact and communicate with all levels in the organization
• Self-starter. Proactive in nature, actively participates and self-motivated
• Experience in CNS therapeutic area preferred
• Experience in Sales Force Design, Targeting, Incentive Compensation preferred
• Experience supporting Veeva CRM applications preferred

SALARY & BENEFITS

The anticipated salary range for this role is $90,000 - $115,000. 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.

JOB SUMMARY

Axsome Therapeutics is currently seeking a Manager, Medical Information to provide accurate, timely, fair-balanced medical information in response to medical inquiries from internal and external customers. This role will be responsible for creation and maintenance of medical information content that will be used to respond to global Medical Information inquiries for Axsome products.  

This is a hybrid role based at Axsome's HQ in New York City. 

JOB RESPONSIBILITIES

• Provide high quality, balanced, and timely responses to unsolicited medical and pharmaceutical inquiries regarding Axsome products from healthcare professional and consumers
• Develop evidence-based standard and custom response documents and FAQ responses on topics related to Axsome products
• Provide training to call center on medical information content and processes
• Work with call center in handling inquiries requiring escalation and customized responses
• Assist with review of content in promotional and medical materials to assure scientific rigor and quality
• Maintain a high level of product and disease state expertise in order to produce the highest quality of medical information support to both internal and external customers
• Continuous monitoring of medical information inquiry trends to ensure appropriate content strategy and as well as communication to the wider organization
• Support medical information booth activities during professional scientific meetings/medical congresses
• Continuous improvement of Medical Information processes and deliverables
• Understand and comply with appropriate ethical, legal, and regulatory standards, including those for responding to unsolicited requests for product information
• Identify and report adverse events and product quality complaints to Pharmacovigilance and Quality Assurance per corporate policies
• Ad hoc project support as needed for efforts in Medical Information and Medical Affairs
• Additional responsibilities as assigned

QUALIFICATIONS

• PharmD preferred
• Minimum of 1-2 years of pharmaceutical/biotechnology industry-based medical information experience
• Understanding of applicable regulations that govern medical information activities
• Proven ability to effectively research, interpret, and assess medical/scientific data. Proficient in searching medical literature databases
• Excellent verbal and written communication skills including ability to present to both internal and external partners and write/summarize scientific and clinical data.
• Demonstrate strong attention to detail
• Strong organizational skills, including the ability to prioritize independently with minimal supervision and collaborate to problem solve
• Prior experience working in Veeva MedComms or other content management or medical information platforms

SALARY & BENEFITS

The anticipated salary range for this role is $100,000 - $122,000. 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.

JOB SUMMARY

Axsome Therapeutics is currently searching for a Manager, Sales Operations to support our commercial product launches. The Sales Operations Manager is responsible for a variety of coordination and execution of key sales operations functions. Key responsibilities include 1) Management and maintenance of sales operations processes, 2) Management of HCP DCC engagement plans to ensure they are effective and efficient, 3) Ensure that field teams maximize the use of data and technology to deliver results and 4) Manage field related compliance operations. This role will report directly to Associate Director of Sales Operations.

This is a hybrid role based at Axsome's HQ in New York City. 

JOB RESPONSIBILITIES

• Work with cross-functional team to optimize and manage field team alignments, HCP engagement plans
• Manage vendors running sales operations processes and reporting
• Manage and provide thought leadership on organizational omnichannel capabilities
• Identifies relevant field KPI’s and works with field leadership to put in place relevant reports/dashboards to understand and effectively manage opportunities
• Create ad hoc analysis/reports to identify opportunities for Field execution based on CRM engagement data and secondary data sources (IQVIA/Symphony)
• Collaborate with broader Commercial Operations team to review data, improve existing processes, and on new projects
• Act as a liaison with Corporate Compliance to ensure all systems support our field representatives and meet compliance requirements
• Leverage CRM/SFA systems to full capabilities and enhance to support the field
• Support Sales leadership in the organization and coordination of National Sales meetings, Manager Meetings, and POA meetings
• Additional responsibilities as assigned

QUALIFICATIONS

• Bachelor’s Degree required
• 3+ years of sales operations experience in the pharmaceutical or biotech industry (which may include work as a consultant or supplier to the industry)
• Experience in CNS therapeutic area is preferred
• Demonstrated knowledge of sales operations and ability to identify and investigate operational needs, and opportunities, and leads the implementation of improvements within area of responsibility
• Experience in Sales Force Design, Alignment, Targeting, Call Planning, and Incentive Compensation
• Experience in omnichannel planning
• Experience supporting Veeva CRM applications
• Understands key pharmaceutical data sources (e.g. IQVIA, Symphony) and data structures to produce insights
• Ability to operate in ambiguous situations and determine focused objectives and a clear path forward in the face of open questions
• Advanced knowledge of MS Office (Excel, PowerPoint, Word) is required
• Experience in programming (SQL, SAS or Python preferred)
• Strong team player with ability to manage conflicting priorities
• Demonstrated ability to work with many cross-functional partners
• Ability to interact and communicate with all levels in the organization
• Self-starter. Proactive in nature, actively participates and self-motivated
• Ability to work on site Monday, Tuesday and Thursday

SALARY & BENEFITS

The anticipated salary range for this role is $95,000-$110,000. 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.

JOB SUMMARY

Axsome Therapeutics is seeking a Manager/Senior Manager of Analytical Development to manage and coordinate analytical activities on multiple early and/or late phase clinical development programs. The ideal candidate will be a team player comfortable working on a small team in a fast paced environment and with contract manufacturing and development organizations. Excellent time management skills and communication will be key in succeeding in this role. This position is non-laboratory based and prior hands-on laboratory experience using a broad array of analytical instrumentation is a requirement.  

This is a hybrid role based at Axsome's HQ in New York City. 

JOB

• Work closely with the CMC team (and specifically the head of analytical development) to manage and coordinate analytical activities on multiple early phase drug substance and drug product small molecule solid oral formulation programs.
• Manage early and/or late phase drug substance and drug product analytical activities at contract development laboratories (method development, method qualifications/validations, method transfers, analytical investigations support).
• Review and/or author analytical technical/development and method qualification/validation reports and raw data as well as release and stability data packages.
• Authoring of CMC sections of regulatory submissions.
• Manage drug substance and drug product stability programs (QC and technical review of stability data packages, including stability data trending).
• Assist in the development of analytical development related policies and standard operating procedures.
• Manage reference materials and reference standards inventory and (re)qualification testing.
• Additional responsibilities as assigned.

QUALIFICATIONS

• Bachelor’s degree in Analytical Chemistry or Chemistry or related field with 7+ years or MS/PhD with 5+ years of GMP and GLP-related pharmaceutical industry experience in small molecule solid oral formulation analytical .
• Knowledge of drug product solid oral dose formulations.
• Hands-on experience with drug substance and drug product analytical techniques such as HPLC, GC, KF, MS, dissolution, spectroscopy, and particle size.
• Functional understanding of small molecule analytical development and associated regulatory and quality requirements.
• In-depth understanding of GMPs and applicable CMC, analytical and manufacturing regulatory .
• Working knowledge of pharmacokinetics and drug metabolism not required but beneficial. 
• Demonstrated experience in managing outsourced analytical activities. 
• Demonstrated experience in QC data review of release and stability data packages for both drug substance and drug product.
• Experience working on commercial stage products highly valued.
• Excellent verbal and written communication skills.
• Excellent problem solving and interpersonal skills.
• Exceptional organizational skills with the ability to multi-task and prioritize workload based upon changing priorities. 
• Ability to work in a cross-functional team environment and to be a team player as well as the ability to work independently.
• Flexibility to accommodate multiple time zones as needed.
• Preference to energetic candidates with a desire to think “outside the box”.
• Willingness to travel periodically as needed.

SALARY & BENEFITS

The anticipated salary range for this role is $120,000 - $130,000. 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.

JOB SUMMARY

Axsome Therapeutics is seeking a Manager/Senior Manager, Compliance. Reporting to the Director, Compliance, this role will help execute elements of the Company’s healthcare compliance program, with an emphasis on auditing and monitoring of business activities. In addition, the candidate for this position will work closely with the Director, Compliance, and other business colleagues and shall assist with managing Axsome’s compliance operations in accordance with company policies, applicable state and federal regulations, and industry standards including those of the FDA, OIG, and CMS.

This is a hybrid role based at Axsome's HQ in New York City. 

 JOB RESPONSIBILITIES

• General Compliance Program Support
• Support the development, implementation, and maintenance of the compliance program, including compliance investigations and training and monitoring workstreams designed to facilitate adherence to compliance policies and healthcare compliance regulations.
• Support the implementation of new and existing FDA and OIG guidance documents, emerging state and federal regulations, and industry codes to current policies, training and monitoring activities as they relate to business activities and communications with healthcare professionals and/or patients or patient advocacy organizations.
• Maintain current understanding of laws and regulations applicable to pharmaceutical/biotechnology compliance, along with recent industry trends and changes.
• Additional responsibilities as assigned.
• Monitoring Program Support
• Provide support to Director, Corporate Compliance in data gathering and execution of quarterly data monitoring activities related to employee adherence to Company Compliance Policies.
• Update and assist with design and maintenance of monitoring dashboard for regional and global visibility to completion of annual monitoring activities.
• Conduct monitoring activities not limited to sitting in on field rides, speaker programs, virtual programs, and advisory boards.
• Travel will be required.
• Transparency Reporting Program Support
• Support process of report submission to federal agencies.
• Manage the current transparency reporting vendor and ensure that all deadlines are met.
• Collaborate with internal stakeholders to ensure that all relevant data sources are collected and submitted for reporting.
• Help enhance global reporting capabilities as Axsome expands.
• Collaborate with Commercial Operations to ensure all state sales rep and disclosure documentation is complete.

QUALIFICATIONS

• 2-4 years of experience working in the pharmaceutical/healthcare legal/compliance/internal audit field required. Experience in-house, at a regulatory agency, or at a major law firm also welcome.
• Bachelors Degree is required.
• Ability to travel extensively to support a robust compliance monitoring program. Travel will include field rides, live monitoring of speaker programs, and advisory boards.
• Experience with statutes, regulations, guidance documents, enforcement trends, and best practices related to the pharmaceutical, biotechnology, and/or healthcare industry generally.
• Experience with the requirements for effective compliance programs as set forth in OIG Guidance and the Federal Sentencing Guidelines.
• Experience with the legal/compliance framework affecting the pharmaceutical/biotechnology industry; including, but not limited to, sales and marketing fraud and abuse issues, OIG and other industry guidance documents, clinical trial regulations, and issues arising under the Anti-Kickback Statute and the False Claims Act.
• Demonstrated effectiveness operating in complex organizational and regulatory environments.
• Excellent written, oral, and presentation skills.
• A strong sense of professionalism, and the drive to provide superb and timely support to internal clients.
• Strong problem solving, risk analysis, and project management skills.
• Demonstrated ability to partner effectively with others in addressing complex issues.
• Strong persuasive skills and sound business judgement.
• Motivated, self-starter with ability to appropriately prioritize issues, drive projects, and allocate resources.
• Ability to work on site Monday, Tuesday and Thursday.

SALARY & BENEFITS

The anticipated salary range for this role is $95,000-$120,000. 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.

JOB SUMMARY

Axsome Therapeutics is seeking a Manager/Senior Manager, Compliance. Reporting to the Director, Compliance, this role will help execute elements of the Company’s healthcare compliance program, with an emphasis on auditing and monitoring of business activities. In addition, this position will work closely with the Director, Compliance, and other business colleagues and shall assist with managing Axsome’s compliance operations in accordance with company policies, applicable state and federal regulations, and industry standards including those of the FDA, OIG, and CMS.

JOB RESPONSIBILITIES

• General Compliance Program Support
• Support the development, implementation, and maintenance of the compliance program, including compliance investigations and training and monitoring workstreams designed to facilitate adherence to compliance policies and healthcare compliance regulations.
• Support the implementation of new and existing FDA and OIG guidance documents, emerging state and federal regulations, and industry codes to current policies, training and monitoring activities as they relate to business activities and communications with healthcare professionals and/or patients or patient advocacy organizations.
• Maintain current understanding of laws and regulations applicable to pharmaceutical/biotechnology compliance, along with recent industry trends and changes.
• Additional responsibilities as assigned.
• Monitoring Program Support
• Provide support to Director, Corporate Compliance in data gathering and execution of quarterly data monitoring activities related to employee adherence to Company Compliance Policies.
• Update and assist with design and maintenance of monitoring dashboard for regional and global visibility to completion of annual monitoring activities.
• Conduct monitoring activities not limited to sitting in on field rides, speaker programs, virtual programs, and advisory boards.
• Travel will be required.
• Transparency Reporting Program Support
• Support process of report submission to federal agencies.
• Manage the current transparency reporting vendor and ensure that all deadlines are met.
• Collaborate with internal stakeholders to ensure that all relevant data sources are collected and submitted for reporting.
• Help enhance global reporting capabilities as Axsome expands.
• Collaborate with Commercial Operations to ensure all state sales rep and disclosure documentation is complete.

QUALIFICATIONS

• 2-4 years of experience working in the pharmaceutical/healthcare legal/compliance/internal audit field required. Experience in-house, at a regulatory agency, or at a major law firm also welcome.
• Bachelors Degree is required.
• Ability to travel extensively to support a robust compliance monitoring program. Travel will include field rides, live monitoring of speaker programs, and advisory boards.
• Experience with statutes, regulations, guidance documents, enforcement trends, and best practices related to the pharmaceutical, biotechnology, and/or healthcare industry generally.
• Experience with the requirements for effective compliance programs as set forth in OIG Guidance and the Federal Sentencing Guidelines.
• Experience with the legal/compliance framework affecting the pharmaceutical/biotechnology industry; including, but not limited to, sales and marketing fraud and abuse issues, OIG and other industry guidance documents, clinical trial regulations, and issues arising under the Anti-Kickback Statute and the False Claims Act.
• Demonstrated effectiveness operating in complex organizational and regulatory environments.
• Excellent written, oral, and presentation skills.
• A strong sense of professionalism, and the drive to provide superb and timely support to internal clients.
• Strong problem solving, risk analysis, and project management skills.
• Demonstrated ability to partner effectively with others in addressing complex issues.
• Strong persuasive skills and sound business judgement.
• Motivated, self-starter with ability to appropriately prioritize issues, drive projects, and allocate resources.
• Ability to work on site Monday, Tuesday and Thursday.

SALARY & BENEFITS

The anticipated salary range for this role is $95,000-$120,000. 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.

JOB SUMMARY

Axsome Therapeutics is seeking a Manager/Senior Manager, Quality to be responsible for ensuring compliance with Good Manufacturing Practices (GMP) with all work performed. This individual will provide Quality oversight of internal and external activities, documentation and processes to assure compliance with company procedures, FDA regulations and assists with tasks necessary to achieve department and/or company goals. The Manager/Senior Manager, Quality will report directly to the VP, Quality.

This is a hybrid role based at Axsome’s HQ in New York City.

JOB RESPONSIBILITIES

• Support the development, implementation, and improvement of corporate quality management systems that support late phase clinical and commercial programs
• Identify and address compliance issues and processes to ensure the QMS is maintained in a state of inspection readiness
• Author, review or revise Standard Operating Procedures (SOPs), Work Instructions (WI) and other controlled documents
• Assist with implementation and management of Axsome’s electronic quality management systems, inclusive of document management, training management, corrective and preventive (CAPA) and change control systems
• Review and approve batch records, validation protocols, reports and other GMP-related documentation and resolve discrepancies as needed
• Lead/participate in GMP audits of external Contract Manufacturing Organizations (CMOs), contract testing laboratories and distribution centers to assure compliance with internal procedures and regulatory guidelines (~10% travel required)
• Conduct audits of internal processes and procedures for adherence to SOPs, company policies, and regulations/standards
• Represents QA in cross functional teams participating in various operational programs such as process development, risk management activities, validation planning and other continuous improvement activities
• Serve as an escalation point for quality issues with regards to investigations, non-conformances and deviations, CAPA and change controls
• Escalate serious compliance issues to senior management
• Assist in the development of quality metrics to drive consistent quality standards throughout the organization
• Maintain relevant knowledge of appropriate GxP requirements and developments as they impact company SOPs and compliance with GxP and communicate these to management, as applicable
• Support regulatory agency inspections as needed
• Additional responsibilities as assigned

QUALIFICATIONS

• A BA or BS degree in a scientific discipline and at least 6 years’ QA experience in the pharma industry
• Proficient knowledge of GMP regulations, guidance documents, systems processes and procedures
• Experience working in Phase 1-3 clinical development through commercial environments is a plus
• Great attention to detail
• Strong interpersonal skills
• Effective communication skills both verbally and written
• Proven ability to multitask projects or varying complexities

SALARY & BENEFITS

The anticipated salary range for this role is $100,000 - $115,000. 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.

JOB SUMMARY

Axsome Therapeutics is seeking a Product Manager/Senior Product Manager, HCP Marketing for SUNOSI®. The PM/SPM, HCP Marketing will be responsible for developing and executing marketing strategy and tactics for SUNOSI®. The HCP Marketer will help to develop and execute HCP marketing initiatives in line with brand strategies and objectives. This role will collaborate cross functionally with Sales, Market Access, Data & Market Analytics, as well as other internal and external partners. This individual will report to the Executive Director, Marketing.

This is a hybrid role based at Axsome’s HQ in New York City.

JOB RESPONSIBILITIES

• Contribute to the development of the marketing plans for SUNOSI® and champion the plan through engagement with internal and external partners
• Lead portions of the development of the integrated brand plan, create programs and tactics to support the strategy, and execute the tactical marketing plans focused on HCP audiences
• Identify appropriate measurements & ROI, and develop comprehensive reporting to evaluate effectiveness of tactical efforts
• Effectively manage key agency partners
• Lead reviews of promotional materials with Regulatory/Legal/Medical
• Collaborate effectively with sales & marketing, market access, market research, medical affairs, commercial operations, data & analytics, finance, and other cross-functional partners
• Identify strategic market opportunities and make recommendations to enhance brand penetration
• Develop mid- to long-range plan for future indications
• Manage timelines and budgets in accordance with brand plan
• Additional responsibilities as assigned

QUALIFICATIONS

• BA or BS; advanced degree preferred
• Minimum 3-5 years of experience in pharmaceutical/biotechnology marketing, with a minimum of 2 years of experience successfully executing HCP-focused campaigns
• Demonstrated proactive, creative and entrepreneurial approach
• CNS disease experience and/or launch experience strongly preferred
• Proven ability to run multiple tasks concurrently under aggressive timelines in a dynamic environment, comfortable with uncertainty and high expectations
• Experience developing, implementing, and working on successful multichannel campaigns
• Strong project and process management skills, including competency in agency management and budget management
• Strong digital marketing aptitude
• Strong interpersonal and presentation skills
• Ability to work on site Monday, Tuesday and Thursday

SALARY & BENEFITS

The anticipated salary range for this role is $120,000 - $140,000. We encourage candidates  Next 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.

JOB SUMMARY

Axsome Therapeutics is currently seeking a Quality Systems Specialist/Sr. Specialist to focus on ensuring compliance with Good Manufacturing Practices (GMP) with all work performed. The Quality Systems Specialist/Sr. Specialist will assist with oversight of internal and external activities, documentation, and processes to assure compliance with company procedures, FDA regulations and assists with tasks necessary to achieve department and/or company goals.

This is a hybrid role based at Axsome's HQ in New York City. 

JOB RESPONSIBILITIES

• Maintain Document Control role for all documents and records maintained in Electronic Quality Management Systems (EQMS).
• Assist in support of processes for updating, routing and approval of electronic documents and records by Axsome personnel.
• Review and log incoming complaints and coordinate with Contract Manufacturing Organizations (CMOs) to initiate complaint investigations.
• Initiate complaint investigations in Axsome’s EQMS.

• Manage corrective and preventive actions resulting from product complaints; as well as deviations and non-conformances as needed.
• Facilitate, monitor and drive change control on time completion.
• Assist with supplier/vendor management by maintaining the approved vendor list.
• Assist in the identification and addressing of compliance issues and processes to ensure the QMS is maintained in a state of inspection readiness.
• Author, review or revise Standard Operating Procedures (SOPs), Work Instructions (WI) and other controlled documents.
• Escalate serious compliance issues to senior management.
• Maintain relevant knowledge of appropriate GxP requirements and developments as they impact company SOPs and compliance with GxP and communicate these to management, as applicable
• Additional responsibilities as assigned

QUALIFICATIONS

• Bachelor of Science degree required, preferably in a scientific discipline
• At least 3 years’ experience working in QA/QC the pharmaceutical industry
• Proficient knowledge of GMP regulations and guidance documents
• Strong attention to detail and excellent organization skills
• Strong interpersonal skills and communication skills (both written and oral)
• Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities
• Ability to work on site Monday, Tuesday and Thursday

SALARY & BENEFITS

The anticipated salary range for this role is $82,000 - $92,000. 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.

JOB SUMMARY

Axsome Therapeutics is seeking a Senior Clinical Research Associate. The CRA will be responsible for site management and monitoring activities at assigned sites across assigned programs ensuring the trial is conducted in compliance with the protocol, ICH/GCP, applicable regulatory requirements and applicable SOPs/Work Instructions.

JOB RESPONSIBILITIES

• Assist with the execution and the timely implementation of clinical research activities for assigned projects.
• Perform clinical monitoring activities (site evaluation, initiation, interim monitoring visits, remote and close-out) and provide overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations.
• Monitor investigative sites and activities to verify the protocol is being followed and study activities are being performed by sites.
• Create thorough monitoring visit reports.
• Act as primary point of contact for assigned investigational sites and cross functional teams and escalate to the study team as necessary.
• Perform and may lead in-house review of clinical data listings for completeness and accuracy and escalate issues to the Lead CRA or CTM and Study Director as needed.
• Responsible for verifying essential documents and study newsletters are present in the Investigator Site File and tracking/reporting of recruitment updates for their assigned sites.
• Participate in the evaluation and training of investigative sites.
• Assist with the organization and management of internal team meetings, investigator meetings, and other trial­ specific meetings as required.
• Maintain completion of required corporate training on standards, policies, and work instructions.
• May conduct CRA assessments and complete thorough assessment reports.
• The Lead CRA supports the development/review of clinical study plans, presentations or project/study-related documents related to monitoring activities including assisting the study team with the day-to-day management of clinical studies.
• The Sr. CRA role also tracks site performance metrics and provide oversight of CROs, internal /contract CRA(s) and vendors, including being a liaison for cross-functional teams.
• In a lead role, a CRA could be responsible for the management of the Monitoring Visit Report (MVR) review, resolution, and escalation.
• In a lead role, a CRA could be responsible for training, mentoring, or supervising junior level staff.
• May participate in co-monitoring, and/or training visits with team members for training purposes.
• Perform other work-related duties as assigned and under the direction of the Clinical Trial Manager or Director.
• Additional responsibilities as assigned.

QUALIFICATIONS

• Minimum of 5 years of clinical trial experience in a pharmaceutical, biotechnology, CRO, and/or healthcare setting (including 5+ years on-site monitoring experience).
• BA/BS or equivalent degree in a scientific discipline or related healthcare field is preferred but not required.
• Demonstrate core understanding of medical terminology or clinical trial activities.
• Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, required.
• Experience in interactions with outside vendors, e.g., CROs and other vendors preferred.
• Experience in CNS preferred.
• Ability to work on complex or multiple projects and exercise critical thinking with minimal supervision.
• Solid attention to detail with proven organizational abilities, and excellent written and oral communication and presentation skills.
• Solid interpersonal skills and communication skills (both written and oral).
• Excellent team player with team building skills willingness and ability to fill functional gaps in a small but 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.
• Demonstrate problem solving and leadership skills.
• 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 small company environment and able to adjust workload based upon changing priorities.
• Willingness to travel (up to 70%).
• Must be located in Florida

SALARY & BENEFITS

The anticipated salary range for this role is $115,000 - $135,000. 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.

JOB SUMMARY

Axsome Therapeutics is seeking a Clinical Quality Sr. Specialist/Manager to provide quality oversight of internal and external clinical trial activities and related records and processes to assure management in accordance with FDA regulations, ICH-GCP, SOPs, and all other applicable regulations. This role assists with tasks necessary to achieve department and/or company goals and will report directly to the VP, Quality.

This is a hybrid role based at Axsome's HQ in New York City. 

JOB RESPONSIBILITIES

• Support the development, implementation, and improvement of corporate quality systems that support early, mid and late phase clinical programs
• Identify and address GCP compliance issues across Axsome clinical systems and processes to ensure a state of readiness for regulatory inspection
• Conduct internal audits of Clinical GCP processes for adherence to SOPs, company policies, and regulations/standards, to include clinical study report audits and trial master file audits
• Plan, conduct, oversee and tracking GCP and GcLP audits of external contract laboratories and CROs to assure compliance with internal procedures and regulatory guidelines
• Assist in resolving compliance issues at clinical sites, clinical vendors, and laboratories; and providing assessment of the impact of any deficiencies
• Assist with ICH/GCP Training at investigator meetings and internally
• Identify and monitor clinical compliance trends and risks for Axsome clinical trials. Escalate compliance issues identified to senior management
• Review and provide input to clinical documentation (e.g. protocols, study reports, IB)
• Contribute to the development of Clinical Operations, Safety and Clinical Quality and Compliance systems and standards
• Develop and measure GCP quality metrics to drive consistent quality standards throughout the organization
• Maintain relevant knowledge of appropriate GxP requirements and developments as they impact company SOPs and compliance with GxP and communicate these to the QA team and QA management, as applicable
• Up to 10% travel may be required
• Perform other work-related duties as assigned

QUALIFICATIONS

• Sr. Specialist: A BA or BS degree in a scientific discipline strongly preferred. At least three (3) years’ experience (5 preferred) working in a GCP quality role in the pharmaceutical clinical research industry required. 
• Manager: A BA or BS degree in a scientific discipline strongly preferred. At least 5 years’ experience (7 preferred) working in a GCP quality role in the pharmaceutical clinical research industry. 1-2 years previous management or supervisory experience required.
• Proficient knowledge of ICH, GCP, and applicable CFRs, guidance documents, systems processes, and procedures
• Experience in clinical operations and handling trial essential documents preferred
• Additional experience conducting GMP/GLP audits a plus
• Great attention to detail
• Strong interpersonal skills
• Effective communication skills, both verbal and written
• Proven ability to manage complex projects

SALARY & BENEFITS

The anticipated salary range for this role is $82,000 - $95,000. 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.

JOB SUMMARY

Axsome Therapeutics is seeking a Specialty Account Manager (SAM) to execute commercial activities for assigned geographies, establish relationships with customers, and ensure a successful launch of Auvelity in major depressive disorder (MDD). This role is field-based and will require gaining access to customers in a clinic or hospital setting while also maximizing the ability to engage through digital channels. 

The Field SAM will be responsible for product performance at a territory level, expected to be a disease category expert and product champion, provide account management support, and exhibit business knowledge of the local landscape to assess key stakeholders plus future trends within the marketplace.

JOB RESPONSIBILITIES

• Proficient in both virtual and live customer engagements
• Develop a comprehensive and effective territory business plan aimed at achieving and exceeding annual goals established by commercial leadership
• Promote Auvelity within approved labeling in a comprehensive, fair, and ethical manner that is consistent with industry specific and corporate legal and regulatory guidelines
• Develop strong customer relationships by better understanding the customer’s needs
• Serve as a resource/consultant to customers and staff regarding payer policies and processes (i.e., eligibility and benefit verification, prior-authorization, and appeals/denials)
• Maximize use of marketing resources to maintain and develop customer relationships for the purpose of growing the customers’ confidence to prescribe Axsome medications for appropriate patients
• Communicate territory activity in an accurate and timely manner as directed by management
• Provide feedback to sales and commercial leadership, colleagues, marketing, and other internal departments about changing environment and results
• Successfully complete all training classes
• Complete administrative duties in an accurate and timely fashion
• Manage efforts within assigned promotional budget
• Must be able to effectively collaborate across all corporate functions
• Attend medical congresses and society meetings as needed
• Ensure timely access for patients through patient services and savings programs
• Additional responsibilities as assigned

QUALIFICATIONS

• Bachelor’s degree from an accredited college or university
• Minimum of 5 years of field customer experience and/or account management
• Demonstrated experience delivering outstanding results
• Minimum of 3 years Pharmaceutical / Medical Sales experience with relevant CNS/Psychiatry experience
• Previous pharmaceutical, biotech, or medical marketing/sales experience with at least five years in specialty sales
• CNS/Psychiatry experience preferred, but not required
• Launch experience strongly preferred
• Experience strategizing within cross-functional teams, utilizing differential resources to achieve business goals
• Proven ability to successfully manage multiple tasks concurrently under aggressive timelines in a dynamic environment
• Comfortability with uncertainty and high expectations
• Patient support services experience a plus
• Strong digital marketing aptitude
• Strong interpersonal, presentation, and communication skills

This role will require minimal overnight travel as indicated by the needs of the business.

JOB SUMMARY

Axsome Therapeutics is seeking a Specialty Account Manager (SAM) to execute commercial activities for assigned geographies, establish relationships with customers, and ensure a successful launch of Auvelity in major depressive disorder (MDD). This role is field-based and will require gaining access to customers in a clinic or hospital setting while also maximizing the ability to engage through digital channels. 

The Field SAM will be responsible for product performance at a territory level, expected to be a disease category expert and product champion, provide account management support, and exhibit business knowledge of the local landscape to assess key stakeholders plus future trends within the marketplace.

JOB RESPONSIBILITIES

• Proficient in both virtual and live customer engagements
• Develop a comprehensive and effective territory business plan aimed at achieving and exceeding annual goals established by commercial leadership
• Promote Auvelity within approved labeling in a comprehensive, fair, and ethical manner that is consistent with industry specific and corporate legal and regulatory guidelines
• Develop strong customer relationships by better understanding the customer’s needs
• Serve as a resource/consultant to customers and staff regarding payer policies and processes (i.e., eligibility and benefit verification, prior-authorization, and appeals/denials)
• Maximize use of marketing resources to maintain and develop customer relationships for the purpose of growing the customers’ confidence to prescribe Axsome medications for appropriate patients
• Communicate territory activity in an accurate and timely manner as directed by management
• Provide feedback to sales and commercial leadership, colleagues, marketing, and other internal departments about changing environment and results
• Successfully complete all training classes
• Complete administrative duties in an accurate and timely fashion
• Manage efforts within assigned promotional budget
• Must be able to effectively collaborate across all corporate functions
• Attend medical congresses and society meetings as needed
• Ensure timely access for patients through patient services and savings programs
• Additional responsibilities as assigned

QUALIFICATIONS

• Bachelor’s degree from an accredited college or university
• Minimum of 5 years of field customer experience and/or account management
• Demonstrated experience delivering outstanding results
• Minimum of 3 years Healthcare Professional experience with relevant CNS/Psychiatry experience will also meet the qualifications for this role
• Previous pharmaceutical, biotech, or medical marketing/sales experience with at least five years in specialty sales
• CNS Psychiatry experience
• Launch experience strongly preferred
• Experience strategizing within cross-functional teams, utilizing differential resources to achieve business goals
• Proven ability to successfully manage multiple tasks concurrently under aggressive timelines in a dynamic environment
• Comfortability with uncertainty and high expectations
• Patient support services experience a plus
• Strong digital marketing aptitude
• Strong interpersonal, presentation, and communication skills

This role will require minimal overnight travel as indicated by the needs of the business.

JOB SUMMARY

Axsome Therapeutics is currently seeking a proactive and dynamic Staff Accountant to contribute and add value to our finance team. The Staff Accountant will be involved in all aspects of general corporate accounting including maintaining the integrity of the general ledger and preparing monthly and quarterly financial statements in accordance with GAAP. As part of ensuring our financial statements are complete and accurate, the role will interact with different functions across the organization.

Ideally, the candidate will have a Bachelor’s in Accounting with minimum of 2 years’ experience between public accounting and private industry, and be able to thrive in a fast-paced and agile organization.

This is a hybrid role based at Axsome's HQ in New York City that will report to the Controller.

JOB RESPONSIBILITIES

• Assist with the monthly close procedures, including prepare journal entries and perform general ledger account reconciliations
• Assist with the review and tie-out of quarterly (10Q) and annual financial statements (10K)
• Assist with the quarterly review and annual audits by independent auditors
• Review expense reports to ensure compliance and process payments accordingly
• Assist with commercial finance activities including analysis over inventory and revenue recognition support
• Review clinical trial subject visit reports and calculate investigator clinical trial expense accruals
• Ensure all new vendor agreements and investigator clinical trial agreements are properly executed and filed
• Verify invoices to supporting documentation and process invoices in accounts payable system
• Prepare check run summaries for review and approval by upper management
• Work with company stock/share transfer agent on various shareholder requests
• Assist in evaluating accounting processes and company-wide internal controls and makes suggestions for improvement
• Create and execute ad hoc reporting and analysis as needed
• Additional responsibilities as assigned

QUALIFICATIONS

• Bachelor’s degree in Accounting/Finance
• 2+ years of accounting experience (industry knowledge not required, but preferred)
• Sarbanes Oxley experience a plus
• Certified Public Accountant a plus. Candidates that have the requisite credits to sit for the CPA exam are eligible for exam fee reimbursement.
• Strong written and oral communication skills with the ability to listen actively and respond to others and drive cross-functional resolutions
• Able to work in a fast-paced, start-up environment with the willingness to “roll-up their sleeves” and take initiative, follow-up, and complete tasks in timely manner
• High attention to detail and accuracy along with the ability to multitask and prioritize
• Team player with the ability to establish and maintain positive working relationships
• Ability to work on site Monday, Tuesday and Thursday

SALARY & BENEFITS

The anticipated salary range for this role is $65,000-$75,000k. 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.

Are you interested in a career opportunity at Axsome, but not an exact match for any of our current openings? Apply to this posting and we’ll keep your information on file for any future opportunities. 

We always look forward to hearing from excellent candidates who share a strong interest in our company’s mission, and we’ll be sure to contact you if any positions open up that you might be a good fit for. Thanks again for your interest in Axsome Therapeutics!

Are you interested in a career opportunity with the Axsome's sales team, but not an exact match for any of our current openings? Apply to this posting and we’ll keep your information on file for any future opportunities. 

We always look forward to hearing from excellent candidates who share a strong interest in our company’s mission, and we’ll be sure to contact you if any positions open up that you might be a good fit for. Thanks again for your interest in Axsome Therapeutics!

JOB SUMMARY

Axsome Therapeutics is currently seeking a TMF Specialist who will be responsible for supporting clinical document filing and management of Trial Master Files (TMFs). This role helps to ensure TMFs are current and inspection-ready for internal and external entities.

This is a hybrid role based at Axsome's HQ in New York City. 

JOB RESPONSIBILITIES

• Works closely with the Clinical Study Team to assist in the set-up, review, and maintenance of study-specific TMFs in accordance with Standard Operating Procedures (SOPs) and regulatory guidelines.
• Collect, review, and index essential documents in accordance with the TMF Structure.
• Act as TMF point-of-contact for Study Teams.
• Assist with the creation and maintenance of TMF study trackers, including tracking effective and expiration dates of relevant documents.
• Provide updates at team meetings of relevant TMF findings and document status as needed.
• Conduct TMF quality reviews to ensure accuracy and completeness, and resolves issues as needed with the Clinical Study Team.
• Ensure TMF is always inspection ready.
• Assist in preparation for and participates in internal or external audits/inspections.
• Demonstrate technical and strategic knowledge of applicable regulatory requirements, including applicable specifications, SOPs and ICH/GCP guidelines. Maintains knowledge of current industry best practices.
• Additional responsibilities as assigned

QUALIFICATIONS

• Bachelor’s degree required, preference to candidates with a life science or nursing degree.
• Prior exposure to clinical research.
• Experience with electronic trial master file system(s) including uploading, reviewing, QC, and approval of study required documents.
• Knowledge of TMF Reference Model preferred.
• Excellent written and oral communication skills.
• Demonstrate experience and ability to manage multiple projects/prioritize.
• Computer proficiency, knowledge of GCP and ICH guidelines and other industry regulations required.
• Must have good organizational skills, be a team player, function independently, and interact comfortably with company personnel as well as vendors.
• Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities.
• Ability to work on site Monday, Tuesday and Thursday

SALARY & BENEFITS

The anticipated salary range for this role is $80,000 - $85,000. 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.