Current Opportunities

JOB SUMMARY

Axsome Therapeutics is seeking a Senior Manager/Associate Director of Commercial Quality Control to lead and support stability programs for all Axsome commercial products to ensure compliance and business needs are met. This includes management and oversight of stability data and stability-related documentation (stability protocols and reports and regulatory submissions) generated by contract manufacturing facilities. The Senior Manager/Associate Director of Commercial Quality Control - Stability will oversee QC systems, policies, procedures, and controls as they relate to QC Stability testing of commercial drug substances and drug products.

The Senior Manager/Associate Director of Commercial Quality Control will report directly to the Executive Director, Quality. This is a hybrid role based at Axsome’s HQ in New York City.

JOB RESPONSIBILITIES

• Coordinate resources to ensure the compliant and timely design, interpretation and reporting of stability studies for Commercial products.
• Approve stability protocols and reports, change controls, specification documents and participate in stability strategy and protocol design.
• Provide expert scientific and operational support to ensure the safety and stability of the products.
• Interact with colleagues from CMC, Regulatory, Quality Assurance and Supply Chain for continuous alignment.
• Ensure compliance of Axsome Stability programs with Health Authority regulations and expectations.
• Prepare stability sections for health authority filings and annual product quality reports.
• Author and/or review applicable stability sections of Regulatory submissions.
• Collaborate with Regulatory CMC, providing expert input to relevant sections of the dossier to ensure submission timelines and regulatory commitments are met.
• Assist with QC investigations and resolve issues related to stability failures and to process deficiencies.
• Coordinate trending analysis out of Stability testing data.
• Prepare and present Quarterly Management review stability updates along with regular updates to the broader site leadership team.
• Lead stability-program related investigations and troubleshooting at external testing sites and ensure timely notification/escalation and resolution of issues.
• Guarantee that stability related standard procedures are established, implemented, and continuously improved to ensure cGMP compliance with regulations in the context of stability testing.
• Lead continuous improvements of systems (procedures and systems) to improve organization effectiveness and ensure compliance.
• Support preparation, management, and response to compliance audits.
• Support regulatory agency inspections, as needed.
• Additional duties as assigned.

QUALIFICATIONS

• Bachelor’s degree in a scientific discipline and 8+ years Quality Control/Stability experience in a commercial biotech/pharma setting.
• Proficient knowledge of GMP regulations, guidance documents, systems processes and procedures.
• Great attention to detail.
• Strong interpersonal skills.
• Effective communication skills both verbally and written.
• Proven ability to multitask projects or varying complexities.
• Experience working in early/late phase clinical development through commercial environments a plus.

JOB SUMMARY

Axsome Therapeutics is seeking a Budget and Contract Specialist. The Budget and Contract Specialist will assist in the financial oversight of Axsome-sponsored clinical trials. Primary responsibilities include developing and negotiating site budgets, supporting site payment, and tracking and forecasting budgets. Candidates for this role are expected to have a strong knowledge of clinical trials and understanding of the clinical trial site contracting process. The Budget and Contract Specialist will be an integral part of the Clinical team and work closely with the Finance team.

This is an in-person hybrid role based at Axsome’s HQ in New York City.

JOB RESPONSIBILITIES

• Assist in the development of clinical trial site budgets
• Assist in the negotiation of clinical trial site budgets and payment terms; liaise with Legal on contract negotiations, as needed
• Facilitate QC review and execution of finalized clinical trial agreements
• Support site payment process through QC review and invoice generation
• Support Finance team on expense and payment reporting, as needed
• Support Financial team audit process, as needed
• Participate in the identification and discussion of opportunities to improve and enhance existing procedures and improve the utilization of financial system tools
• Additional responsibilities as assigned

QUALIFICATIONS

• Bachelor’s degree from an accredited college or university
• 2+ years in clinical research industry with at least 1 year of direct budget negotiation experience
• Excellent analytical skills including advanced proficiency in Excel and the ability to quickly manipulate and analyze large data sets and build reports
• Strong knowledge of clinical trials and good clinical practice (GCP)
• Self-driven professional with the ability to work independently and collaboratively, as required, in a fast-paced, team environment
• Strong ability to organize work effectively and to adapt to changing priorities and deadlines

JOB SUMMARY

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

This is a hybrid position that requires travel and in-person work. 

JOB RESPONSIBILITIES

• Assist with the execution and the timely implementation of clinical research activities for assigned projects.
• Perform clinical monitoring activities (site evaluation, initiation, interim monitoring visits, remote and close-out) and provides 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 lead as necessary
• Perform and may lead in-house review of clinical data listings for completeness and accuracy and escalate issues to the Lead CRA or CTM and Study Director as needed.
• Responsible for verifying essential documents and study newsletters are present in the Investigator Site File and tracking/reporting of recruitment updates for their assigned sites.
• Participate in the evaluation and training of investigative sites.
• Assist with the organization and management of internal team meetings, investigator meetings, and other trial­ specific meetings as required.
• Maintain completion of required corporate training on standards, policies and work instructions.
• May conduct CRA assessments and complete thorough assessment reports.
• The Lead CRA supports the development/review of clinical study plans, presentations or project/study-related documents related to monitoring activities.
• The Lead CRA role also tracks site performance metrics.
• In a lead role, a CRA could assist with providing oversight of CROs, internal /contract CRA(s) and vendors, including being a liaison for cross-functional teams.
• In a lead role, a CRA could review monitoring trip reports and track resolution of all action items.
• May participate in co-monitoring, and/or training visits with junior team members for training purposes.
• Perform other work-related duties as assigned and under the direction of the Clinical Trial Manager or Director.

QUALIFICATIONS

• Minimum of 3 years of clinical trial experience in a pharmaceutical, biotechnology, CRO, and/or healthcare setting.
• 1+ years on-site monitoring experience required.
• BA/BS or equivalent degree in a scientific discipline or related healthcare field is preferred but not required.
• Demonstrates core understanding of medical terminology or clinical trial activities.
• Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, required.
• Experience in interactions with outside vendors, e.g., CROs and other vendors preferred.
• Experience in CNS preferred.
• Ability to work on complex or multiple projects and exercise critical thinking with minimal supervision.
• Solid attention to detail and excellent organization skills.
• Solid interpersonal skills and communication skills (both written and oral).
• Excellent team player, 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.
• Demonstrates 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.
• Must be based in Texas.
• Willingness to travel (up to 70%).

JOB SUMMARY

The Clinical Research Scientist will be critical to the Clinical Lead and support the day-to-day scientific conduct of our clinical trials. This is an in-person hybrid role based at Axsome’s HQ in New York City.

JOB RESPONSIBILITIES

• 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 or data cleaning issues.
• Support medical data review and medical coding review.
• Provide training to CRAs and clinical study team, as needed.
• Provide scientific insight into study design and disease process.
• Lead or support protocol development and writing.
• Lead or support Investigator’s Brochure updates.
• Lead or support annual regulatory reporting (eg, IND annual reports).
• Facilitate development of case report forms.
• Work with other internal functional areas (eg., Regulatory, Safety, DM) to support the study
• 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.
• Authors, reviews and revises Standard Operating Procedures (SOPs).
• Assist in the preparation of abstracts, poster presentations, slides, and manuscripts of clinical study findings.
• All other duties as required.

QUALIFICATIONS

• Advanced degree (Pharm.D., MPH, PhD, MS) with at least 1 year of clinical development experience at a pharmaceutical company, or RN/BA/BS with 2+ years of relevant clinical development experience at a pharmaceutical company
• Strong analytical skills with excellent communication (both oral and written)
• Experience writing clinical documents (eg, protocols, CSRs, IBs, DSURs). Experience with regulatory documents (INDs, briefing books, NDAs) a plus
• Proficiency with MS Office suite
• 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%

JOB SUMMARY
The Clinical Trial Assistant is responsible for supporting the organization to successfully develop and implement clinical trials across its product portfolio and development pipeline. This role provides support to the clinical trial manager, the field based CRAs, and the investigational sites.  This role will be a key study team member responsible for multiple clinical trials (all phases) and assure compliance with SOPs, FDA regulations, GCP and ICH guidelines.

This is an in-person hybrid role based at Axsome’s HQ in New York City.

JOB RESPONSIBILITIES

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

REQUIRED EDUCATION AND EXPERIENCE

• Bachelor's degree required. Preference to candidates with a life science or nursing degree
• Prior experience in clinical research
• Must have good organization skills, be a team player, function independently, and be able to interact comfortably with company personnel as well as vendors and investigational sites
• Computer proficiency, GCP, and basic clinical research terminology knowledge required
• Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities
• Excellent team player; willingness and ability to fill functional gaps in a small but growing organization
• Preference to energetic candidates with a desire to think “outside the box”

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.

This is an in-person hybrid role based at Axsome’s HQ in New York City.

JOB RESPONSIBILITIES

• Work in close collaboration with regulatory and CMC to develop and execute program strategies from IND through all phases of clinical 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
• Oversee or lead protocol development, Investigator’s Brochures, annual regulatory reporting, and clinical study reports
• Train clinical study team on therapeutic area, drug product, and protocol, as needed
• Oversee or lead authoring of 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
• Additional responsibilities as assigned

QUALIFICATIONS

• D. required with at least 5 years of clinical development experience at a pharmaceutical company
• Familiarity with the overall drug development process up to and including clinical trial initiation and execution (IND submission through Ph3 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%

JOB SUMMARY

Axsome Therapeutics is seeking a Director, Corporate Counsel. Reporting to the EVP, Legal & Compliance, the Director, Corporate Counsel will serve as a generalist with an emphasis on working as a business partner to key functions involved in commercialization of Axsome’s commercial products. This role will also be a member of Axsome’s Promotional Review Committee, review and negotiate contracts, and collaborate with other members of the Legal & Compliance Team to ensure alignment and execution of the team’s mission and business goals. 

This is an in-person hybrid role based at Axsome’s HQ in New York City.

JOB RESPONSIBILITIES

• Serve as brand attorney and legal business partner, providing legal advice and strategic guidance on a broad set of healthcare and general corporate matters in support the business, including by advising Marketing, Sales, Medical Affairs, and Market Access.
• Counsel on appropriate communications about our products and relationships with external stakeholders, including healthcare professionals, patients, academic institutions and payors.
• Participate on the PRC & MLR Committees, providing legal feedback on advertising, promotional and educational materials submitted for review.
• Collaborate with other members of Legal & Compliance Team to support planning and execution of pre-launch and launch activities.
• Work with business unit personnel to review and negotiate a wide range of agreements.
• Keep informed of new laws, regulations, and industry trends affecting the organization and assist with the development of policies and training as needed.
• Additional responsibilities as assigned.

QUALIFICATIONS

• JD from an accredited law school and admission to New York Bar or ability to obtain admission.
• 5-7 years of legal experience in the pharmaceutical industry at a law firm and/or in an in-house legal department.
• Prior experience advising on advertising and promotional matters at a law firm or as a member of an in-house legal department of a commercial-stage pharmaceutical company, including participation in promotional and medical review processes.
• Strong base of knowledge and experience advising clients on laws and regulations governing the pharmaceutical industry, including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, state and federal data privacy laws, and product liability laws.
• Strong contract negotiation, interpretation and drafting skills.

JOB SUMMARY

Axsome Therapeutics is currently seeking a Director, Pharmacovigilance Operations. This role is responsible for the oversight of the Pharmacovigilance (PV) Quality Management System including oversight of PV safety vendor activities, leading interactions between pharmacovigilance and other internal departments, monitoring PV quality/compliance activities, and liaising with external partners for the contractual exchange of safety information. This position requires an experienced and accomplished safety operations professional who can provide functional and technical expertise while collaborating with multiple stakeholders.

This is an in-person hybrid role based at Axsome’s HQ in New York City.

JOB RESPONSIBILITIES

• Oversight of safety vendor activities including the case processing of adverse events in the global safety database for investigational and approved products; reconciliation of adverse event information with partners and other parties, and the production of a variety of safety reports
• Oversight of submissions of expedited reports to the FDA & other health authorities
• Develop standard procedures and guidelines for safety operations
• Participate in the creation of cross-functional Pharmacovigilance procedures
• Effectively utilize Key Performance Indicators and other metrics to assess compliance, productivity, opportunities for quality improvement, and to measure effectiveness of change initiatives
• Proactively lead case processing/ case quality improvement initiatives
• Fully support training of department personnel and other line functions involved in AE collection or processing such as Medical Affairs, sales, medical information, etc., in collaboration with the Quality organization
• Negotiate safety data exchange agreements and processes with business partners
• Provide support and subject matter expertise during audits and inspections
• Ensure readiness and management of FDA inspections
• Represent drug safety on project teams, other departments, and committees as needed
• Additional responsibilities as assigned

QUALIFICATIONS

• Bachelor’s degree required
  • Advanced degree or health care certification preferred
• Minimum 7 years of experience in the pharmaceutical/biotechnology industry and 5 years of experience in pharmacovigilance operations
• Strong Pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations, including knowledge of case processing, expedited reporting rules, and safety database concepts
• Prior experience overseeing or interacting with an external safety vendor required
• Strong expertise with safety databases required
• Prior experience negotiating/reviewing PV safety exchange agreements
• Previous experience in drug safety pre-approval (ranging from early to late-stage) and in the post-marketing setting
• Demonstrates leadership and interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues
• Strong organizational skills, including the ability to prioritize independently with minimal supervision and collaborate to problem solve
• Excellent verbal and written communication skills including ability to present to both internal and external partners
• Strong working knowledge of tools such as Microsoft Office and other project management applications

JOB SUMMARY

Axsome Therapeutics is currently seeking a Drug Safety Physician. This role is responsible for leading product level safety analysis and medical safety management for our products throughout their lifecycle. The Drug Safety Physician is accountable for providing medical input to the assessment of the safety profile for each drug and for appropriate and timely regulatory reporting of safety issues.

This is an in-person hybrid role based at Axsome’s HQ in New York City.

JOB RESPONSIBILITIES

• Lead the medical reviews of individual case reports from ongoing clinical studies and post-marketing sources
• Lead safety signal detection activities, monitors product risk-benefit assessment, and safety assessment activities of our products
• Provide medical significance and expectedness assessment of AE/SAE reports and approving AE/SAE case narratives, compile analysis of similar events (AOSE) and support ad-hoc safety analyses as required by health authorities
• Provide medical interpretation of clinical safety data for signal detection and signal evaluation purposes, and to determine the medical significance of any findings
• Contribute to the preparation of, reviews, and approve aggregate safety reports required by health authorities such as, Periodic Benefit-Risk Evaluation Reports (PBRER), US Periodic Adverse Drug Experience Report (PADER), Investigator Brochures, Development Safety Update Reports (DSURs), etc.
• Ensure compliance with standard operating procedures and with national and international, regulatory, safety and pharmacovigilance regulations
• Develop and maintain current pharmacovigilance knowledge and ensure that team is aware of new and existing relevant procedures, guidance, and regulations
• Act as medical and scientific subject matter expert for the pharmacovigilance capabilities build of a growing function within the Company
• Additional responsibilities as assigned

QUALIFICATIONS

• MD or foreign equivalent
• At least 5 years’ experience in the pharmaceutical industry, with at least 2 years of direct pharmacovigilance experience
• Excellent understanding of pharmacovigilance regulatory environment with working knowledge of international regulations, initiatives, standards, Good Pharmacovigilance Practices (GVP), and Good Clinical Practice (GCP)
• Ability to work on complex or multiple projects and exercise independent judgment within generally defined practices and policies lead to obtaining results
• Strong attention to detail and excellent organization skills
• Strong interpersonal skills and communication skills (both written and oral)
• 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

JOB SUMMARY

The Manager, Clinical Data Management is responsible for support of data management activities in compliance with ICH GCP, regulatory guidelines/standards and applicable SOPs. This role supports clinical trial managers (CTMs), clinical research associates (CRAs), and medical monitors in all data management related activities across multiple clinical programs. The Manager will serve as a lead clinical data manager on designated clinical trial(s).

This is an in-person hybrid role based at Axsome’s HQ in New York City.

JOB RESPONSIBILITIES

• Leads clinical data management oversight of one or more clinical trials
• Serves as primary liaison for data management vendor, when applicable, as well as primary resource for study team and CRAs
• Drafts and reviews Data Management Plans, Case Report Forms (CRF) Completion Guidelines, and other documents
• Reviews CRFs and edits check specifications per protocol as well as participates in user acceptance testing of CRFs and associated edit check specifications, as required
• Performs subject level and study aggregate review of clinical data through CRFs or data listings
• Develops and oversees data management timelines
• Gathers metrics to support risk-based monitoring
• Represents data management function on the clinical team meetings and ensures aligned expectations between the vendor and Axsome
• Ensures achievement of major data management deliverables and milestones in coordination with other functions including Clinical Operations, Safety, Statistics, etc.
• Maintains all data management documentation to ensure inspection readiness of the Trial Master File (TMF)
• Generates, tracks, and oversees queries to resolve problematic data identified during every aspect of the data management process
• Performs and reviews quality control procedures and checks to ensure high data quality standards are met
• Generates safety listings and presents to Medical Monitor and study team

REQUIRED EDUCATION AND EXPERIENCE

• Bachelor’s degree required; preference to candidates with a life science degree
• At least 3 years’ data management experience in a biotech / pharmaceutical company or clinical research organization (CRO) OR at least 4 years’ experience at a clinical research site
• Preference to candidates with prior small company experience
• Good understanding of FDA, GCP, and ICH guidelines
• Experience with electronic data capture systems / technologies as applied to clinical trials
• Good working knowledge of (e)CRF design and data management functions and activities
• CDISC (CDASH and SDTM) experience preferred
• Good working knowledge of Microsoft Office software (i.e., Microsoft Excel)
• Ability to handle multiple programs simultaneously
• Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities
• Preference to energetic candidates with a desire to think “outside the box”
• Strong attention to detail and excellent organization skills

JOB SUMMARY

Axsome Therapeutics is currently seeking a Manager of Medical Information. The Manager of Medical Information will be responsible for providing 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 Medical Information inquiries for Axsome products. The manager will serve as an integral member of the Medical Affairs team, providing input on medical planning and delivering on medical affairs objectives for entire portfolio of CNS assets. 

This is an in-person 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

• Candidates with a PharmD degree preferred
• Minimum of 1-2 years of pharmaceutical/biotechnology industry-based medical information experience required
• 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

JOB SUMMARY

Axsome Therapeutics is seeking a Quality Assurance Specialist/Senior Specialist to focus on ensuring compliance with Good Manufacturing Practices (GMP) with all work performed. The QA Specialist/Senior Specialist will provide the Quality Assurance team oversight of external manufacturing activities to ensure consistent compliance with company procedures, regulations, and industry expectations. This position will report directly to the Executive Director, Quality.

This is an in-person hybrid role based at Axsome’s HQ in New York City.

JOB RESPONSIBILITIES

• Review executed batch production records ensuring compliance with approved procedures and GMP expectations; communicate and resolve discrepancies with third-party CMOs and GMP test labs
• Review release test and stability data ensuring data accuracy, conformance to test procedures, specifications, and documentation standards
• Review and track manufacturing deviations and OOSs working collaboratively with internal staff to respond to and resolve deviations and OOSs
• Follow through on corrective and preventive actions from deviations and OOS
• Provide support in the review and approval of cGMP-controlled documents such as master batch records, test methods, and specifications
• Provide support in the review of change controls related to manufacturing, test methods, and specifications to meet cGMP and internal standards
• Assist with the reporting and presentation of department metrics including annual product reviews
• Provide QA support for validations including reviewing protocols and reports
• Write and review Standard Operating Procedures, as needed
• Support the development, implementation, and improvement of corporate quality management systems that support late phase clinical and commercial programs.
• Support regulatory agency inspections as needed
• Additional responsibilities as assigned

QUALIFICATIONS

• 1 to 3 years’ Quality Control or Quality Assurance experience working in an FDA regulated industry required
• BS degree in a scientific discipline strongly preferred 
• Proficient knowledge of GMP regulations, guidance documents, systems processes, and procedures
• Experience working in Phase 1-3 clinical research through commercial environments is a plus
• Strong attention to detail
• Strong interpersonal skills and communication skills (both written and verbal)
• Proven ability to multitask projects or varying complexities

COMPANY DESCRIPTION

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.

 
JOB SUMMARY

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

JOB RESPONSIBILITIES

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

QUALIFICATIONS

• Minimum of 5 years of clinical trial experience in a pharmaceutical, biotechnology, CRO, and/or healthcare setting (including 5+ years on-site monitoring experience).
• BA/BS or equivalent degree in a scientific discipline or related healthcare field is preferred but not required.
• Demonstrate core understanding of medical terminology or clinical trial activities.
• Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, required.
• Experience in interactions with outside vendors, e.g., CROs and other vendors preferred.
• Experience in CNS preferred.
• Ability to work on complex or multiple projects and exercise critical thinking with minimal supervision.
• Solid attention to detail with proven organizational abilities, and excellent written and oral communication and presentation skills.
• Solid interpersonal skills and communication skills (both written and oral).
• Excellent team player with team building skills willingness and ability to fill functional gaps in a small but growing organization.
• Ability to establish priorities, excellent sense of urgency and desire to collaborate (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendors.
• Demonstrate problem solving and leadership skills.
• Self-motivated and adaptable to a dynamic environment.
• Computer skills including proficiency in the use of Microsoft Office, CTMS, eTMF and eCRF platforms and organization tools.
• Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities.
• Willingness to travel (up to 70%).
• Must be located in Florida or Georgia. 

COMPANY DESCRIPTION

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.

JOB SUMMARY

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

JOB RESPONSIBILITIES

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

QUALIFICATIONS 

• Bachelor’s degree in Analytical Chemistry or Chemistry or related field with 7+ years or MS/PhD with 5+ years of GMP and GLP-related pharmaceutical industry experience in small molecule solid oral formulation analytical development.
• Knowledge of drug product solid oral dose formulations.
• Hands-on experience with drug substance and drug product analytical techniques such as HPLC, GC, KF, MS, dissolution, spectroscopy, and particle size.
• Functional understanding of small molecule analytical development and associated regulatory and quality requirements.
• In-depth understanding of GMPs and applicable CMC, analytical and manufacturing regulatory guidance. 
• Demonstrated experience in managing outsourced analytical activities. 
• Demonstrated experience in QC data review of release and stability data packages for both drug substance and drug product.
• Experience working on commercial stage products highly valued.
• Excellent verbal and written communication skills.
• Excellent problem solving and interpersonal skills.
• Exceptional organizational skills with the ability to multi-task and prioritize workload based upon changing priorities. 
• Ability to work in a cross-functional team environment and to be a team player as well as the ability to work independently.
• Flexibility to accommodate multiple time zones as needed.
• Preference to energetic candidates with a desire to think “outside the box”.
• Willingness to travel periodically as needed.

COMPANY DESCRIPTION

Axsome Therapeutics, Inc. is a 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.

 
JOB SUMMARY

Axsome Therapeutics is seeking a Senior Medical Science Liaison to focus on multiple CNS therapeutic areas including major depressive disorder, migraine, and sleep medicine. The Senior MSL will be a key member of the Field Medical Affairs team at Axsome. This position will be the primary communicator of Axsome science and will be responsible for executing the national medical affairs plan within a specified territory. The Senior MSL will also provide as needed support for other pipeline programs.

JOB RESPONSIBILITIES

• Systematically identify and develop relationships with healthcare professionals (HCPs) to raise awareness of Axsome’s mission to accelerate the invention and adoption of life-changing medicines for patients living with CNS disorders
• Provide fair and balanced scientific information to HCPs and to internal business partners per organizational needs
• Lead scientific discovery and communicate meaningful insights gleaned from peer-to-peer discussions with HCPs
• Identify, analyze, and translate specific needs within the territory to achieve clinical and business objectives
• Collaborate with internal partners, as appropriate, to advance clinical and business objectives
• Build and maintain technical and clinical expertise across a broad range of neuroscience therapeutic areas
• Continually educate self on global and regional market issues, trends, and product knowledge as it pertains to key therapeutics areas
• Actively contribute to the growth and development of the National Field Medical Team
• Deliver relevant health economic data to key stakeholders including payers and HCPs
• Execute key job functions, including documentation of field activities, submission of medical insights, completion of medical information requests, expense report submission, required trainings, and other tasks as necessary
• Provide high level support for company sponsored trials and aides in navigating investigator-initiated research proposals through the review process, when needed
• Additional responsibilities as assigned

QUALIFICATIONS

• At least 5 years of clinical and/or industry experience required
• Preference for candidates with an Advanced degree: MD, PharmD, or PhD
• Preference for candidates with relevant industry/therapeutic experience and launch experience
• Ability to thrive in an entrepreneurial and autonomous environment where business needs may rapidly evolve and change
• Meet requirements for health industry representative credentialing to gain access to healthcare facilities within the territory
• Strong attention to detail and excellent organization skills
• Strong interpersonal skills and communication skills (both written and oral)
• Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities
• Ability to travel up to 75%, including overnight stays, as needed

COMPANY DESCRIPTION

Axsome Therapeutics, Inc. is a 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.

 
JOB SUMMARY

Axsome Therapeutics is seeking a Senior Medical Science Liaison to focus on multiple CNS therapeutic areas including major depressive disorder, migraine, and sleep medicine. The Senior MSL will be a key member of the Field Medical Affairs team at Axsome. This position will be the primary communicator of Axsome science and will be responsible for executing the national medical affairs plan within a specified territory. The Senior MSL will also provide as needed support for other pipeline programs.

JOB RESPONSIBILITIES

• Systematically identify and develop relationships with healthcare professionals (HCPs) to raise awareness of Axsome’s mission to accelerate the invention and adoption of life-changing medicines for patients living with CNS disorders
• Provide fair and balanced scientific information to HCPs and to internal business partners per organizational needs
• Lead scientific discovery and communicate meaningful insights gleaned from peer-to-peer discussions with HCPs
• Identify, analyze, and translate specific needs within the territory to achieve clinical and business objectives
• Collaborate with internal partners, as appropriate, to advance clinical and business objectives
• Build and maintain technical and clinical expertise across a broad range of neuroscience therapeutic areas
• Continually educate self on global and regional market issues, trends, and product knowledge as it pertains to key therapeutics areas
• Actively contribute to the growth and development of the National Field Medical Team
• Deliver relevant health economic data to key stakeholders including payers and HCPs
• Execute key job functions, including documentation of field activities, submission of medical insights, completion of medical information requests, expense report submission, required trainings, and other tasks as necessary
• Provide high level support for company sponsored trials and aides in navigating investigator-initiated research proposals through the review process, when needed
• Additional responsibilities as assigned

QUALIFICATIONS

• At least 5 years of clinical and/or industry experience required
• Preference for candidates with an Advanced degree: MD, PharmD, or PhD
• Preference for candidates with relevant industry/therapeutic experience and launch experience
• Ability to thrive in an entrepreneurial and autonomous environment where business needs may rapidly evolve and change
• Meet requirements for health industry representative credentialing to gain access to healthcare facilities within the territory
• Strong attention to detail and excellent organization skills
• Strong interpersonal skills and communication skills (both written and oral)
• Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities
• Ability to travel up to 75%, including overnight stays, as needed

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/Psychiatry experience will also meet the qualifications for this role.
• Previous pharmaceutical, biotech, or medical marketing/sales experience with at least five years in specialty sales preferred.
• CNS Psychiatry 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

• Demonstrate 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/Psychiatry experience will also meet the qualifications for this role.
• Previous pharmaceutical, biotech, or medical marketing/sales experience with at least five years in specialty sales preferred.
• CNS Psychiatry 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/Psychiatry experience will also meet the qualifications for this role.
• Previous pharmaceutical, biotech, or medical marketing/sales experience with at least five years in specialty sales preferred.
• CNS Psychiatry 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/Psychiatry experience will also meet the qualifications for this role.
• Previous pharmaceutical, biotech, or medical marketing/sales experience with at least five years in specialty sales preferred.
• CNS Psychiatry 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.