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.

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.

About This Role:

Axsome Therapeutics is seeking a highly collaborative, self-motivated Medical Writer to draft, edit and submit high quality, medically accurate documents including manuscripts, conference abstracts, and posters. This is a key position within Medical Affairs with ample opportunity to make real impact. 

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

• Independently interprets complex data and develops high-quality strategic scientific documents including abstracts and full length manuscripts that align to the Medical Affairs strategy
• Coordinates the review, approval, submission, and production of publications
• Participate in the planning, development and implementation of the medical educational plan, publication plan, and other scientific programs that align to the Medical Strategy. Closely collaborates with and applies strategic direction from project and publication leads, and biostatisticians in order to manage and prioritize assignments to ensure deliverables are completed per time and quality goals
• Develops documents for assigned programs in compliance with company standard operating procedures (SOPs)
• Works with cross-functional internal teams to ensure wide acceptability of documents and consensus of content
• Support key strategic meetings with internal and external stakeholders and manage the output from these meetings. Oversees outsourced medical writings projects and the associated vendor(s), as applicable
• Critically analyzes, synthesizes, and presents complex information
• Drives Results
• Ensures Accountability

Requirements / Qualifications

• Advanced scientific or clinical degree (MD, PhD, or PharmD) required and a minimum of 5-8 years relevant experience required
• Track record of developing high-quality scientific documents from inception to publication

Experience and Knowledge:

• Ability to interpret, evaluate, and communicate (in a variety of formats and styles) complex scientific and clinical data
• Expertise in use of online and other data sources for literature searches and information
• General knowledge of the drug development and approval processes
• Ability to work with cross-functional executive leadership and exposure to sensitive information, necessitating considerable use of tact, diplomacy, discretion, and judgment
• Ability to work collaboratively and coordinate the efforts of team members to resolve comments and complete deliverables
• Ability to manage/prioritize multiple projects under general supervision, working in a fast-paced environment
• Flexible and able to adapt to changing deadlines and priorities
• Excellent written, verbal, and interpersonal communication skills
• Highly attentive to detail
• Self-motivated and able to self-manage effort to maintain alignment with strategy and corporate goals
• Demonstrates Self-awareness

Salary and Benefits:

The anticipated salary range for this role is $170,000 - $185,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.

About This Role:

Axsome Therapeutics is seeking a highly collaborative Medical Writer to draft, edit and submit high quality, medically accurate documents including protocols, clinical study reports, manuscripts, conference abstracts, and posters. This is a key position within CNS scientific communication with ample opportunity to make real impact. The medical writer reports to the Head of Clinical Development, with a dashed dotted line to the Medical Affairs/HEOR lead as applicable.

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

• Interpret complex data and develops high-quality strategic scientific documents including protocols, amendments, agency briefing books, clinical study reports, publications and other documents in support of Medical Affairs, RWE/HEOR and/or Clinical Development programs   
• Attends strategic meetings as applicable
• Closely collaborates with, and apply applies strategic direction from, project and publication leads, and biostatisticians in order to manage and prioritize assignments to ensure deliverables are completed per time and quality goals
• Previous experience with preparation and QC of various document types: core clinical documents (protocols, IBs, CSRs, etc.), Health Authority Submission documents (Agency Briefing Documents, eCTD Summary Documents, Orphan Drug Applications), etc is a plus
• Develops documents for assigned programs in compliance with company standard operating procedures (SOPs). (Previous experience with preparation and QC of various document types: core clinical documents (protocols, IBs, CSRs, etc.), Health Authority Submission documents (Agency Briefing Documents, eCTD Summary Documents, Orphan Drug Applications), etc is a plus)
• Develops documents for assigned programs in compliance with company standard operating procedures (SOPs)
  •    This may include developing timelines, review/approval workflow management, and/or QC/publication readiness
• Works with cross-functional internal teams to ensure wide acceptability of documents and consensus of content
• Oversees outsourced medical writings projects and the associated vendor(s), as applicable
• Critically analyzes, synthesizes, and presents complex information
• Drives Results
• Ensures Accountability

Requirements / Qualifications

• Advanced scientific or clinical degree (MD, PhD, or PharmD) required and a minimum of 5-8 years relevant experience
• A strong current working knowledge of the pharmaceutical environment is required.

Experience and Knowledge:

• Highly knowledgeable in the relevant disease areas
• Track record of developing high-quality scientific documents
• Ability to interpret, evaluate, and communicate (in a variety of formats and styles) complex scientific and clinical data
• Expertise in use of online and other data sources for literature searches and information
• General knowledge of the drug development and approval processes and GXP principles
• Ability to work with cross-functional executive leadership and exposure to sensitive information, necessitating considerable use of tact, diplomacy, discretion, and judgment
• Ability to work collaboratively and coordinate the efforts of team members to resolve comments and complete deliverables
• Ability to manage/prioritize multiple projects under general supervision, working in a fast-paced environment
• Flexible and able to adapt to changing deadlines and priorities
• Excellent written, verbal, and interpersonal communication skills
• Highly attentive to detail
• Able to self-manage effort to maintain alignment with strategy and corporate goals

Salary and Benefits:

The anticipated salary range for this role is $170,000 - $185,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.

About This Role

Axsome Therapeutics is seeking an Associate/Sr. Associate, Regulatory Operations. The role is responsible for managing regulatory operations necessary to ensure the successful preparation and filing of regulatory submissions for Axsome’s product candidates.

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

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

• Coordinate publishing activities for eCTD submissions including ensuring regulatory documents are submission ready, transferring final documents for publishing, completing QC of published output, and confirming submission to the health authority
• Maintain electronic document management system and RIM systems for the Regulatory Department
• Track and archive submissions, correspondences, and commitments with health authorities
• Interact with vendors in support of electronic publishing and other aspects of regulatory operations
• Assist with authoring, tracking, and maintaining ClinicalTrials.gov in accordance with 42 CFR Part 11 guidelines
• Review essential regulatory documents for drug shipment authorization to clinical study sites
• Participate in the development, review, and implementation of departmental SOPs, initiatives and processes

Requirements / Qualifications

• Bachelors Degree required
• 1-3 years of relevant Regulatory Affairs/Regulatory Operations experience
• Understanding of the regulatory requirements for electronic submissions and have had prior experience with regulatory document publishing
• Demonstrated experience with electronic document management / regulatory information management (RIM) systems, as well as maintaining online clinical trial registries
• Ability to work on site Monday, Tuesday & Thursday

Experience and Knowledge

• Understanding of eCTD requirements, FDA electronic gateway submissions, and FDA guidance documents
• Operational experience supporting investigational and/or marketed products (INDs/CTAs, NDAs/MAAs)
• Prior experience with regulatory document publishing and submission, preferred
• Prior experience with RIM systems, preferred
• Prior experience with ClinicalTrials.gov, preferred
• Proficiency with Microsoft Office Suite and Adobe Acrobat
• Ability to learn new software packages and electronic systems
• Strong attention to detail and excellent organization skills
• Exceptional time-management skills
• Strong interpersonal skills

Salary and Benefits:

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

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

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.

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.

About This Role

Axsome Therapeutics is hiring a Director, Commercial Analytics and Forecasting to provide analytical and forecasting expertise to the commercial organization for launch of key Axsome products. This position will work directly with commercial leadership team (Marketing, Sales, Value & Access) in executing commercial analytics and forecasting projects that support the brand commercialization strategy for key products in Axsome’s CNS pipeline. This critical role will report directly to Senior Vice President of Commercial Operations.

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

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

• Generate analytics-based insights by leveraging various pharmaceutical data sources (longitudinal patient data, HCP prescribing data, payor data, national and subnational data on key metrics like patients, prescriptions, sales etc.)
• Collaborate closely with other commercial analytics and insights team members to ensure insights from secondary data analytics are appropriately integrated with insights from other sources
• Update and maintain brand forecast models to reflect the latest competitive intelligence landscape, customer research and insights from claims data
• Create short term and long term forecasts and effectively communicate them to various stakeholders at Axsome (Commercial, Finance, Supply Chain etc..)
• Translate commercial analytics results to help deepen our understanding of market opportunities and customer behaviors
• Turn unstructured business issues/requests into appropriate analytical action plans and projects that result in high quality, meaningful and actionable deliverables
• Provide accurate and in-depth analyses to commercial leadership teams and serves as an integral part of the commercial team
• Support initiatives by leveraging expertise in drawing insights from large data sets
• Manage multiple complex pieces of data analysis and translating that analysis into actionable commercial insights
• Identify, evaluate, and manage relationships with best-in-class analytics vendors

Requirements / Qualifications

• Bachelors Degree required. Advanced degree in related field preferred (MBA, or MS)
• Minimum 7 years pharmaceutical or biotechnology experience in Commercial Analytics/Forecasting or Sales Analytics roles
• Previous product launch experience
• Ability to work on site Monday, Tuesday & Thursday

Experience and Knowledge

• CNS research experience preferred
• Ability to run statistical analyses, contribute to new analysis methodologies, and engage with Analytics/statistical modeling experts
• Experience with pharmaceutical data sources (e.g., IMS, SHA, Syndicated data sources)
• Experience working with CRM data systems like Salesforce, Veeva, etc.
• Experience with data visualization and business intelligence tools (e.g., Tableau, PowerBI etc.)
• Proficiency in Microsoft Office applications (Excel, PowerPoint)
• Database querying skills (SQL, SAS etc.)
• Demonstrated exceptional strategic / critical thinking abilities and business acumen
• Demonstrated analytical skills—understands the advantages and limits of different analytical/quantitative approaches
• Familiarity with launch and pre-launch planning, tracking and measurement
• Demonstrated ability to dig deep and the uncover the “why” beneath observations
• Excellent oral, written and presentation skills with ability to explain complex concepts clearly to a variety of audiences
• Ability to work collaboratively in team-based environment
• Ability to balance multiple projects and workstreams simultaneously

Salary & Benefits

The anticipated salary range for this role is $190,000 - $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.

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City

About This Role

Axsome Therapeutics is seeking a Director, Pricing and Contracting to support our growing commercial portfolio and Market Access team. Reporting to the Senior Director, Pricing and Contracting, this role will interact with colleagues in Market Access and cross functionally with Executive Leadership, Finance, Legal and Compliance and Brand teams. This position will also interact with key third party partners, including Commercial GPOs and PBMs, State Medicaid, CMS, HRSA, and others as needed.

The Director, Pricing and Contracting is a strategically important role that will drive successful execution of Market Access strategies for Axsome’s inline and pipeline products. This role will lead Axsome’s contract administration and compliance efforts, including rebate administration, payment workflows, state Medicaid invoice processing, etc.

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

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

• Establish internal processes for Contract Compliance by working collaboratively across the organization
• Lead Axsome’s Government Pricing Compliance efforts, collaborating with internal team members and external service providers. Ensure accuracy and timely completion of reported prices (AMP, BP, PHS, NFAMP, etc.)
• Ensure appropriate execution of approved and finalized payer/PBM contracts, including working with internal and external partners to validate adjudicated rebates, fees, price protection, and other price concessions
• Establish audit plan to review top contracted formularies across Commercial, Medicare Part D and Managed Medicaid segments
• Partner with Trade and Distribution function to establish and implement 340B rebate compliance strategy across distribution/payer/PBM customer segments
• Assess and implement oversight over revenue leakage risk through contracting and contract compliance efforts, including duplicate discount and chargeback mitigation, rebate non-compliance, price calculation and reporting, and other areas of gross-to-net risk
• Lead Government Channel contracting strategy across VA, DoD, PHS, Medicaid, and Medicare segments
• Strong project management skills. Demonstrated experience of working with third-party partners, transitioning third-party partners, and implementing large scale, high-impact projects.
• Develop strategic, analytically robust, and comprehensive business cases evaluating contracting requests from Commercial and Government payers for presentation to the Pricing & Terms Committee
• Monitor and evaluate contract performance for all customer segments and share key learnings with Market Access and Commercial leadership team on a periodic basis; identify areas for improvement and recommend course of action
• Act as subject matter expert and fulfill all Federal and State Reporting requirements for Axsome, including but not limited to AMP, URA, PHS Ceiling Price, NFAMP, FCP, BP, WAC changes, etc
• Act as subject matter expert and lead accurate and appropriate implementation of Government Pricing Calculations, Reporting obligations, Class of Trade Schema determination, Federal & State reporting requirements, Chargeback and Rebate Processing, Government Claims Processing, and Managed Care Rebate Processing
• Lead Government Price (GP) Reporting vendors and ensuring processes and procedures are well-documented
• Collaborate with Finance to develop, inform and maintain Gross-to-Net calculations, forecasts, and reviews with internal and external stakeholders

Requirements / Qualifications

• Bachelor’s degree required. Master’s degree in accounting, finance, business administration or data analytics preferred
• 5+ years’ experience of Market Access contracting, pricing, contract administration, and contract compliance
• Excellent Project Management skills with demonstrated history of implementing large scale projects, and transitions
• Zero-to-One experience of building teams, internal and external stakeholder partnerships, comprehensive processes, and knowledge of industry best practices
• Ability to work on site Monday, Tuesday & Thursday

Experience and Knowledge

• In-depth knowledge of pharmaceutical pricing, stakeholder incentives, reimbursement practices and regulatory requirements
• Experience of auditing PBMs, GPOs, and other external contracted partners
• Advanced knowledge of Commercial, Medicare, Medicaid, VA, DoD, 340B, and other programs and payer policies
• Strong understanding and knowledge of Government price calculations and compliance regulations
• Prior experience in Managed Care Rebate processing, GP reporting and methodologies, claim adjudication highly preferred
• Strong problem-solving skills, including incorporating framework driven thinking and data driven analytics; ability to collate data and insights from disparate data sources and recommend understandable solutions to complex problems
• Strong team player with demonstrated ability to work in a deadline driven and fast paced environment, managing multiple priorities and workstreams simultaneously
• Proactive, intellectually curious, willing to learn and adapt, strong analytical thinking, framework driven approach to problem solving, strong communication and presentation skills, solid team player
• Ability to interact and communicate with all levels in the organization and influence in a matrix environment

Salary & Benefits

The anticipated salary range for this role is $190,000 - $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 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.

Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.
 
Summary:
Axsome Therapeutics is seeking a Manager/Senior Manager, CMC to support Axsome’s clinical, registration, and commercial development and manufacturing efforts for drug product. Interfaces with vendors and CMOs/CDMOs. The position reports to the Director, CMC and will manage essential duties and responsibilities as independently as possible. Key interactions may include the supply chain, regulatory, quality and management teams.

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

• Participate as a key member of the CMC and development team
• Support clinical through late-stage drug product development and manufacturing activities for the company’s product candidates, including clinical supply, registration and validation manufacturing
• Support technology transfer processes for drug product
• Interface with drug substance and drug product vendors and CDMOs
• Review batch records, tech transfer reports, campaign summaries and other related CMC documents
• Work closely with the CMC project team to develop and implement process development plans; manage process development activities and document information and data in appropriate format (reports, spreadsheets, etc.)
• Proactively monitor manufacturing processes and identify areas for process improvement and optimization; work with internal and external CMC teams to find solutions
• Assist with preparation of written documents for regulatory submissions (e.g. INDs, CTAs, MAAs, NDAs for CMC Module 3)
• Identify and evaluate vendors and CDMOs as needed

Requirements / Qualifications:

• Bachelors degree, Masters degree or PhD and 7 - 10 years of relevant experience in a biotech/pharmaceutical company 

Preference to candidates with a strong scientific background (i.e. chemistry, pharmaceutical sciences, polymer science, engineering, formulation development)

Preference to candidates with prior start-up experience

• Ability to work on-site Monday, Tuesday, and Thursday

Experience and Knowledge:

• Solid knowledge and understanding of CMC, formulation, process development, scale-up, and manufacturing of pharmaceutical oral dosage forms required
• Hands-on experience in research and development and/or scale-up and manufacturing required
• Manufacturing experience (registration, validation and/or technical transfer) of solid oral dosage forms is required
• Experience in project management and interaction with CDMOs required
• Solid knowledge of cGMP. Experience working in a cGMP environment required
• Knowledge and/or familiarity of analytical procedures related drug product methods
• Understanding of FDA regulatory guidance, ICH guidelines and requirements of NDA and IND’s
• Experience with preparation and review of INDs, NDAs, other regulatory documentation and submissions preferred
• Problem solving and good 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
• Willingness to travel periodically domestic/international as needed.

Salary & Benefits:

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

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.

 
About This Role

Axsome Therapeutics is seeking a TMF Manager who will be responsible for overseeing clinical document filing and quality controls. This role ensures TMFs are current and inspection-ready for internal and external entities as well. This position is responsible for the clinical documentation control process training for study teams.

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

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

• Support the development and review of Standard Operating Procedures and Work Instructions related to Clinical Document Management, as appropriate
• Create and maintains Written Instructions, Guidelines and Plans as they relate to TMFs and document control
• Oversee the creation of document trackers as needed as well as the collection of metrics related to use of the TMF
• Establish and maintain Naming and Filing Guide(s) for relevant electronic TMF (eTMF) systems
• Work closely with the Clinical Study Team to assist in the set-up, review, maintenance, and archival of study-specific TMFs in accordance with regulatory guidelines
• Provide regular updates at team meetings of relevant TMF findings and document status
• Conduct or oversees routine TMF quality reviews to ensure TMF accuracy and completeness
• Proactively inform CRAs (site-level) and CTMs (study-level) of deficiencies from informal reviews
• Prepare for and participate in internal or external audits/inspections including providing audit/inspection responses and facilitating inspector access to TMFs, as required
• Demonstrate technical and strategic knowledge of applicable regulatory requirements, including applicable specifications, standard operating procedures, ICH/GCP guidelines and other regulatory requirements. Maintain knowledge of current industry best practices
• Perform or manage QC checks of TMFs as needed

Requirements / Qualifications

• Bachelors degree required. Preference to candidates with a life science or nursing degree
• Minimum of three (3) years of experience in a biotechnology/pharmaceutical industry or other related relevant experience
• Computer proficiency, knowledge of GCP and ICH guidelines and other industry regulations required
• Demonstrated knowledge of regulatory requirements related to clinical trial document start up, retention and archival
• Experience with electronic trial master file system(s) including uploading, reviewing, QC, approval of study required documents. Familiarity with TMF Reference Model preferred
• Ability to work on site Monday, Tuesday & Thursday

Experience and Knowledge

• Significant experience with clinical trial document management
• Demonstrated experience managing multiple projects and ability to prioritize
• Strong leadership skills, self-motivated, adaptable to a dynamic environment
• Must be a team player, function independently, and interact comfortably with company personnel as well as vendors
• Ability to problem solve, delegate appropriate tasks and/or mentor junior team members
• Excellent written and oral communication skills
• Strong attention to detail and organizational skills
• Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities

Salary & Benefits

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

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.

About this role
Axsome Therapeutics is currently searching for a Senior Brand Manager, Consumer Marketing to lead the direct-to-consumer strategic plan and the implementation of patient tactics to support the patient journey for a fast-growing brand in the CNS space. This role is responsible for developing insights, brand management, and execution excellence to reach and engage patients. The Senior Brand Manager will collaborate cross functionally with HCP Marketing, Patient Support Services, Market Access, Data & Market Analytics, as well as other internal and external partners. This individual will report to the Associate Director, Consumer Marketing.

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

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

●    Develop and execute patient marketing tactical plan in line with brand strategies and objectives
●    Have a deep understanding of patient segments, needs, and channel preferences
●    Develop and implement promotional media and social media strategy by leveraging digital capabilities, innovation, and best practices to drive patient engagement for the brand including identifying and piloting future marketing areas of opportunity
●    Champion the Brand Ambassador Program by working directly with patients to highlight their unique stories across various channels
●    Lead the measurement and optimization of campaigns across digital channels
●    Effectively manage the Consumer AOR and Media Agency
●    Identify strategic market opportunities and make recommendations to enhance brand penetration 
●    Champion initiatives through medical, legal, regulatory review process
●    Collaborate effectively with sales & marketing, market access, patient support, market research, medical affairs, commercial operations, data & analytics, finance, and other cross-functional partners 
●    Manage the timelines and ensure key deliverables meet deadlines and business objectives.
●    Actively contribute to the development of the annual brand plan and budget

Requirements / Qualifications

●    BA or BS degree required

●    Minimum of 2-3 years of experience in consumer marketing, and 4-6 years of pharmaceutical marketing experience 

Experience and Knowledge

●    Demonstrated proactive, creative and entrepreneurial approach
●    CNS disease experience and/or launch experience strongly preferred
●    Experience working with and directing agencies and strategic vendors 
●    Proven ability to run multiple tasks concurrently under aggressive timelines in a dynamic environment, comfortable with uncertainty and high expectations
●    Patient support services experience a plus
●    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 & Thursday

Salary and Benefits:

The anticipated salary range for this role is $140,000 - $155,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.

About this role

Axsome Therapeutics is seeking a Senior Clinical Research Associate. The Senior Clinical Research Associate 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 and Duties include, but are not limited to, the following

• 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
• Verify that essential documents and study newsletters are present in the Investigator Site File and track and report 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
• Support 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
• Track site performance metrics and provide oversight of CROs, internal /contract CRA(s) and vendors, including being a liaison for cross-functional teams

Requirements / Qualifications

• BA/BS or equivalent degree required. BA/BS in a scientific discipline or related healthcare field is preferred
• Minimum of 5 years of clinical trial experience in a pharmaceutical, biotechnology, CRO, and/or healthcare setting (including 5+ years on-site monitoring experience)
• Demonstrated core understanding of medical terminology or clinical trial activities required
• Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, required
• Must live in California and be willing to travel (up to 70%)

Experience and Knowledge

• 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
• 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

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.

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.

About This Role:

Axsome Therapeutics is seeking a Senior Clinical Research Associate. The Senior Clinical Research Associate 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 and Duties include, but are not limited to, the following:

• 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
• Verify that essential documents and study newsletters are present in the Investigator Site File and track and report 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
• Support 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
• Track site performance metrics and provide oversight of CROs, internal /contract CRA(s) and vendors, including being a liaison for cross-functional teams

Requirements / Qualifications

• BA/BS or equivalent degree required. BA/BS in a scientific discipline or related healthcare field is preferred
• Minimum of 5 years of clinical trial experience in a pharmaceutical, biotechnology, CRO, and/or healthcare setting (including 5+ years on-site monitoring experience)
• Demonstrated core understanding of medical terminology or clinical trial activities required
• Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, required
• Must live in Florida and be willing to travel (up to 70%)

Experience and Knowledge

• 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
• 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

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.

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.

About This Role:

Axsome Therapeutics is seeking a Senior Clinical Research Associate. The Senior Clinical Research Associate 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 and Duties include, but are not limited to, the following:

• 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
• Verify that essential documents and study newsletters are present in the Investigator Site File and track and report 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
• Support 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
• Track site performance metrics and provide oversight of CROs, internal /contract CRA(s) and vendors, including being a liaison for cross-functional teams

Requirements / Qualifications

• BA/BS or equivalent degree required. BA/BS in a scientific discipline or related healthcare field is preferred
• Minimum of 5 years of clinical trial experience in a pharmaceutical, biotechnology, CRO, and/or healthcare setting (including 5+ years on-site monitoring experience)
• Demonstrated core understanding of medical terminology or clinical trial activities required
• Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, required
• Must live in Texas and be willing to travel (up to 70%)

Experience and Knowledge

• 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
• 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

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 Director of Clinical Development. The Director of Clinical Development is responsible for leading the clinical program for one or more product candidates within a specific therapeutic area (psychiatry or neurology). This role will act as the Clinical Program Lead for the assigned product candidates including product planning and life cycle management.

JOB RESPONSIBILITIES

• Lead the creation of and provide scientific insight into study designs and disease area strategy
• Oversee or lead protocol development, Investigator’s Brochures, annual regulatory reporting, and clinical study reports
• Work in close collaboration with regulatory and CMC to develop and execute program strategies from IND through all phases of clinical development
• Engage Key Opinion Leaders for innovation approaches to study design and drug development
• Develop timelines and integrated program plans for the tracking of product / project deliverables
• Champion and facilitate program team meetings, cross-functional communication and decision making, ensuring alignment with internal and external stakeholders
• Partner with the Clinical Study Team to oversee the execution of clinical studies
• Provide scientific insight into study design and disease process
• Train clinical study team on therapeutic area, drug product, and protocol, as needed
• Oversee or contribute to Clinical Study Reports (CSR), and clinical sections of INDs and NDAs (Module 5)
• Drive and present abstracts, poster presentations, slides, and manuscripts of clinical study findings
• Author, review, and revise Standard Operating Procedures (SOPs), as needed
• Lead/contribute to publication planning, authoring and presentation of abstracts, posters, slides, and manuscripts
• Assist Medical Monitor with review of subject eligibility
• Contribute to pharmacovigilance monitoring AEs, SAEs, and FDA reporting and database reconciliation
• Participate in data review of clinical and safety measures at the patient level and in aggregate to assure subject safety and efficient study conduct
• Supervise or mentor other Clinical R & D team members
• Additional responsibilities as assigned

QUALIFICATIONS

• Post-graduate degree required, science-focused qualifications strongly preferred, e.g., MS., PharmD, PhD, with at least 10 years of clinical research experience
• Strong understanding of the drug development process up to and including clinical trial initiation and execution (IND submission through Ph 4 studies)
• Experience in preparing and submitting INDs and (s)NDA
• Strong analytical and problem-solving skills with excellent communication (both oral and written)
• Experience writing clinical documents (eg, protocols, CSRs, IBs,) and regulatory documents (eg, INDs, briefing books, NDAs)
• 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”
• 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 $245,000 - $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.

Company Description

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.

 
About this role

Axsome Therapeutics is seeking a Senior Director, Medical Affairs responsible for the development of medical strategy and execution of tactics related to the company’s strategy for an approved product. This is an expert scientific and medical position focused on providing leadership of core Medical Affairs deliverables such as scientific exchange, evidence generation, cross-functional collaboration, and planning and execution of activities for AXS-07 in migraine. As such, the position will require deep understanding and experience in neuroscience, the role of Medical Affairs, and planning and driving projects.

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

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

• Lead tactical execution of the Integrated Evidence Generation Planning Process (IEGP) including RWE and Phase 4 high priority studies
• Plan and execute an integrated medical strategy for assigned products/molecule(s) that addresses current and future needs of the business
• Lead the Medical Core Team meetings (MCT)
• Lead the development of the strategic scientific communication platform(s) aligned with the brand strategy and franchise strategy across lifecycle and molecules
• Monitor and leverage medical insights to support and inform brand strategy
• Work with clinical and commercial partners to support Market Access, Commercial Development, Value and HEOR activities (market research, speaker’s bureau, advisory boards, etc.)
• Support the expert engagement plan and overall scientific communication strategy including medical congress content, medical booth, and educational materials development, authorship and review of abstracts and manuscripts
• Guide Independent Medical Education (IME) grants strategy and vetting of medical education providers and their scientific expertise in therapeutic areas of interest
• Oversee CME/grant requests, processes, and progress
• Medical and strategic oversight of company investigator initiated (IITs) trials
• Work with Field Medical functions to establish scientific exchange priorities, disseminate field medical insights throughout the organization, and support regional needs
• Meet all administrative and compliance related activities within policy and on-time
• Assure oversight and management of vendors operationalizing Axsome’s medical capabilities
• Develop and track appropriate budget setting, resource allocation and expense monitoring

Requirements / Qualifications

• Advanced degree (MD, PharmD and/or Doctorate) in neuroscience required, MD desirable
  • Neurology / neuroscience experience from working in medical affairs/clinical development is preferred
  • Experience in migraine highly desirable.
• Minimum 7 years of relevant experience
• Ability to work on site Monday, Tuesday & Thursday

Experience and Knowledge

• Experience with strategic and tactical planning for pipeline and/or marketed product required
• Experience with strategic evidence and scientific communication planning processes
• Experience leading phase IV, real-world evidence, and other post-marketing studies
• Experience working with field medical teams
• Experience with relevant medical specialists highly desirable
• Strong collaborative, interpersonal and team interaction skills, experience working in a cross-functional team environment and ability to execute a must
• High degree of professionalism, integrity and collaboration required
• Exceptional verbal, written and communication skills
• Ability to travel required (~ 30%)
• Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities
• Thorough knowledge of company policies and processes

Salary & Benefits

The anticipated salary range for this role is $200,000 - $240,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.

About This Role:

Axsome Therapeutics is seeking a Senior Manager/Associate Director, Patient Advocacy to help maximize the impact that the patient voice has at Axsome. This role will drive communications and engagement with patient advocacy organizations to build new and expand existing partnerships, foster collaboration, and identify future areas of mutual interest to help improve the lives of patients with CNS disorders. In addition, the Senior Manager/Associate Director, Patient Advocacy will assess the landscape of advocacy groups, and their needs, and lead the development of strategic engagement plans in collaboration with cross-functional partners. 

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

• Lead development and execution of strategic plans for patient advocacy and stakeholder engagement across programs/therapeutic areas
• Develop and support relationships with patient advocacy organizations across the company’s portfolio
• Serve as a liaison and primary point of contact between patient advocacy organizations and Axsome as it relates to clinical trials, medical affairs initiatives, patient & caregiver materials, and external communications
• Collaborate with clinical operations, medical affairs, marketing, corporate communications, market access and other cross functional teams on patient-focused initiatives
• Develop and manage a budget for patient advocacy group support (e.g. yearly sponsorship levels)
• Represent the company at patient conferences, medical congresses, and other patient-centered meetings
• Ensure compliance with corporate policies and procedures, as well as applicable laws and regulations

Requirements / Qualifications

• Bachelors degree required and a minimum of 5 years of experience working with patient advocacy groups in a relevant pharmaceutical, non-profit, or consulting setting
• A strong current working knowledge of the pharmaceutical environment is required
• Ability to work onsite at our NYC HQ Mondays, Tuesdays and Thursdays 

Experience and Knowledge

• Experience forming partnerships with patient advocacy organizations
• Experience working with patients with mental health conditions or patients of CNS or other chronic diseases preferred
• Experience with clinical research and therapeutic areas relevant to Axsome’s portfolio preferred

Salary and Benefits:

The anticipated salary range for this role is $125,000 - $150,000. 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 Product Manager, HCP Marketing for SUNOSI®. The 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 - $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 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 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.

COMPANY DESCRIPTION

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.

 
JOB SUMMARY

Axsome Therapeutics is seeking a Specialty Account Manager (SAM) to execute commercial activities for the assigned geography and establish relationships with customers to drive demand for Sunosi (solriamfetol) in approved patients. SUNOSI is indicated to improve wakefulness in adults with excessive daytime sleepiness due to obstructive sleep apnea or narcolepsy. This role is field-based and will require gaining access to customers in a clinic or hospital setting while also maximizing your ability to engage through digital channels

The SAM will be responsible for product performance at a territory level, expected to be a disease category expert, a 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

• Proficiency 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 Sunosi 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.
• Serves as a resource/consultant to customers and staff regarding payer policies and processes (i.e., eligibility and benefit verification, prior-authorization, and appeals/denials).
• Maximizes 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.
• Communicates territory activity in an accurate and timely manner as directed by management.
• Provides feedback to sales and commercial leadership, colleagues, marketing, and other internal departments about changing environment and results.
• Successfully completes all training classes.
• Completes administrative duties in an accurate and timely fashion.
• Manages efforts within assigned promotional budget.
• Must be able to effectively collaborate across all corporate functions.
• Attends medical congresses and society meetings as needed.
• Ensures 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/Sleep 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 preferred.
• CNS/Sleep experience preferred.
• 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.

JOB SUMMARY

Axsome Therapeutics is seeking a Specialty Account Manager (SAM) to execute commercial activities for the assigned geography and establish relationships with customers to drive demand for Sunosi (solriamfetol) in approved patients. SUNOSI is indicated to improve wakefulness in adults with excessive daytime sleepiness due to obstructive sleep apnea or narcolepsy. This role is field-based and will require gaining access to customers in a clinic or hospital setting while also maximizing your ability to engage through digital channels

The SAM will be responsible for product performance at a territory level, expected to be a disease category expert, a 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

• Proficiency 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 Sunosi 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.
• Serves as a resource/consultant to customers and staff regarding payer policies and processes (i.e., eligibility and benefit verification, prior-authorization, and appeals/denials).
• Maximizes 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.
• Communicates territory activity in an accurate and timely manner as directed by management.
• Provides feedback to sales and commercial leadership, colleagues, marketing, and other internal departments about changing environment and results.
• Successfully completes all training classes.
• Completes administrative duties in an accurate and timely fashion.
• Manages efforts within assigned promotional budget.
• Must be able to effectively collaborate across all corporate functions.
• Attends medical congresses and society meetings as needed.
• Ensures 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/Sleep 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 preferred.
• CNS/Sleep experience preferred.
• 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.

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!