Current Opportunities

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 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.

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

The Clinical Programmer, Clinical Data Management is responsible for supporting 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 technical data management related activities across multiple programs.

JOB RESPONSIBILITIES

• Generates data listings and patient profiles to support data management and other functions in review of clinical data
• Assists in external vendor reconciliation
• Supports the development of data transfer agreements/specifications with external vendors
• Reviews and maintains data migrations or integrations
• Supports QC work of statistical/programming deliverables
• Serves as liaison with technical statistics/programming vendors
• Ensures appropriate documentation and QC of deliverables
• Participates and provides input in electronic Case Report Forms (eCRFs) and edit check specifications development
• Creates statistical/programmatic outputs to be used in final reports, publications, posters, manuscripts, etc.
• Gathers metrics to support risk-based monitoring

REQUIRED EDUCATION & EXPERIENCE

• Bachelor’s degree required. Preference to candidates with a statistics, life sciences or IT related degree
• At least 2 years’ experience in primarily SAS programming in a biotech/pharmaceutical company or clinical research organization (CRO)
• 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
• Strong working knowledge of CDISC standards, including SDTM and ADaM
• Good working knowledge of (e)CRF design and clinical data
• 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”

The Clinical Quality Auditor/Manager provides 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 Executive Director, Quality.

JOB RESPONSIBILITIES

• Up to 50% travel may be required
• 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

REQUIRED EDUCATION AND EXPERIENCE

• Auditor: A BA or BS degree in a scientific discipline with at least three (3) years’ experience (5 preferred) working in a GCP quality role in the pharmaceutical clinical research industry 
• Manager: A BA or BS degree in a scientific discipline with 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

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 in the Midwest. 

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 (including 1+ years on-site monitoring experience).
• 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.
• Willingness to travel (up to 70%).

The Axsome team is comprised of a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. The Clinical Research Scientist will be critical to the Clinical Lead and support the day-to-day scientific conduct of our clinical trials.

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.

REQUIREMENTS:

• 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.

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 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”

The Clinical Trial Assistant, TMF Specialist is responsible for supporting clinical document filing and management of Trial Master Files (TMFs). This role helps ensure TMFs are current and inspection-ready for internal and external entities.

JOB RESPONSIBILITIES

• Works closely with the Clinical Study Team to assist in the set-up, review, and maintenance of study-specific TMFs in accordance with Standard Operating Procedures (SOPs) and regulatory guidelines
• Collects, reviews, and indexes essential documents in accordance with TMF structure
• Acts as TMF point-of-contact for study teams
• Assists with the creation and maintenance of TMF study trackers, including tracking effective and expiration dates of relevant documents
• Provides updates at team meetings of relevant TMF findings and document status as needed
• Conducts TMF quality reviews to ensure accuracy and completeness, and resolves issues as needed
• Ensures TMF is always inspection ready
• Assists in preparation for and participates in internal or external audits / inspections
• All other duties as required

 REQUIRED EDUCATION AND EXPERIENCE

• Bachelor’s degree required, preference to candidates with a life science or nursing degree
• Prior exposure to clinical research
• Familiarity with electronic TMF system(s) including uploading, reviewing, QC, approval of study required document; knowledge of DIA reference model preferred
• Excellent written and oral communication skills
• Demonstrated experience and ability to manage and multiple projects / priorities
• Computer proficiency, knowledge of GCP, and basic clinical research terminology knowledge required
• Must have good organizational skills, be a team player, function independently, and interact comfortably with company personnel as well as vendors
• Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities

The Clinical Trial Manager is the primary operational contact for the study and leads the cross-functional team for execution of the study.

The Clinical Trial Manager provides strategic and operational leadership to the clinical operations 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.

The Clinical Trial Manager is responsible for mentoring Clinical Trial Associates, as appropriate. 

JOB RESPONSIBILITIES

• Responsible for all operational aspects and progress of clinical trial from study planning activities to study execution including ongoing tracking all applicable performance metrics and quality indicators
• Serves as an escalation point and resource for study team and investigational sites
• Facilitates site feasibility / selection processes
• Develops and oversees subject recruitment / retention strategy and related initiatives
• Provides operational and strategic input and/or approves study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Plans, including Clinical Monitoring Plan, , etc.
• Responsible for oversight of clinical operations teams in review of clinical data; provides guidance on issues / queries as needed and implements risk management concepts as appropriate
• Responsible for and participates in clinical vendor selection process as a part of outsourcing activities
• Provides oversight for all vendor operational activities (e.g., study management, monitoring, specifications development, UATs, issues escalations)
• Oversees the TMF set-up, ongoing quality review, and final reconciliation of study documents including review of site regulatory documents
• Ensures that all aspects of GCP compliance and audit readiness are maintained throughout trial conduct
• Creates, manages, measures, and reports timelines for milestone deliverables
• Proactively manages and identifies potential study issues and risks and recommends and implements solutions with key internal / external stakeholders
• Oversees internal team meetings, investigator meetings, and other trial- specific meetings
• Participates in the development, review, and implementation of departmental SOPs, initiatives, and processes
• Reviews and approves vendor invoices for all clinical trial vendors including investigative sites
• Responsible for oversight, growth, and development of 1-2 direct reports, as applicable.
• Perform other work-related duties as assigned

 REQUIRED EDUCATION AND EXPERIENCE

• Bachelor degree required
  • Preference to candidates with a scientific background (RN, MS, PhD or similar)
• 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 and excellent organizational skills
• Strong interpersonal skills and communication skills (both written and oral)
• Ability to problem solve, delegate appropriate tasks and/or mentor junior team members
• 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% (when travel conditions permit)

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:

• 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
• All other duties as required.

REQUIREMENTS:

• Advanced degree (M.D., Pharm.D., or PhD) 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)
• 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%

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

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

JOB RESPONSIBILITIES

• Ensure disciplined and effective communication with key payer stakeholders and decision makers
• Execute the payer engagement strategy and leverage Payer Value Proposition to obtain appropriate access/formulary position among target accounts
• Profile key payer accounts to assess formulary review process, formulary coverage policies, utilization management deployed for the applicable therapeutic areas, and geographic coverage areas
• Identify and address potential barriers to access proactively to ensure launch product is well positioned for formulary and P&T reviews
• Identify competitive threats and develop strategies to ensure optimal coverage for Axsome Therapeutics’ portfolio of products
• Lead pull-though initiatives that capitalize on formulary wins and lead push-though efforts in areas with access challenges
• Ensure compliance with Axsome Therapeutics’ corporate policies and procedures and U.S. healthcare laws and regulations

QUALIFICATIONS

• Bachelor’s Degree in business, marketing, economics, or health sciences
• Minimum 5-10 years of successful National Account Management experience
• Demonstrated experience gaining formulary access for a launch product at multiple national and regional payer accounts and PBMs
• Previous experience at a pre-commercial biopharmaceutical company
• Negotiation experience, preferably in competitive primary care therapeutic areas
• Analytical mindset and history of leveraging HEOR data to articulate a value story that ensures rapid formulary coverage of launch products
• A problem-solving mindset with demonstrated “lean-forward” approach and ability to think critically
• Strong understanding of the payer landscape and how payer decision making impacts providers and their patients
• Excellent oral, written and presentation skills with ability to influence decision makers and explain complex concepts clearly to a variety of audiences
• Previous product launch experience, preferably in the CNS space
• Familiarity with current legal and regulatory landscape pertinent to the industry

The HR Coordinator will serve as a trusted advisor to our internal teams – providing every day support to employees on policies, benefits, and other questions. The HR Coordinator will support the HR function and assist with all aspects of the employee lifecycle with a focus on Recruiting, Onboarding, and Benefits Support.

JOB RESPONSIBILITIES

• Employee benefits “help-desk” – provide first point of contact for employees’ requests and benefits questions
• Assist with onboarding tasks such as background checks and other new hire documentation
• Assist with processing leave of absence and terminations
• Assist with recruitment and interview process: track status of candidates in ATS and work with hiring managers to advance the pipeline
• Coordinate employee events and L&D Opportunities
• Coordinate and support various HR programs and initiatives
• Schedule meetings and interviews as requested
• Maintain HR process documentation and communication of policies and procedures

REQUIRED EDUCATION AND EXPERIENCE

• 2+ years in Human Resources
• Bachelor’s degree or equivalent
• Experience working in a fast-paced, startup environment
• Extremely organized, detail-oriented, collaborative, and curious
• Strong communication skills with the ability to interact at all levels of the organization
• Ability to deal with ambiguity and to problem solve
• Proven experience managing People systems and processes
• Proven experience with benefits administration
• Experience with a benefits review or implementing new systems preferred but not required

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).

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

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 guidances. 
• 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.

The Senior Manager/Associate Director, CMC will support Axsome’s clinical, registration, and commercial development and manufacturing efforts. Interfaces with vendors and CMOs. The position reports to the VP, CMC and will manage essential duties and responsibilities as independently as possible. Key interactions with the supply chain, regulatory, quality and management teams.

RESPONSIBILITIES:

• Participate as a key member of the CMC and development team.
• Oversee and support late-stage development and manufacturing activities for the company’s product candidates, including registration, validation and commercial manufacturing.
• Support technology transfer processes for drug substance and drug product.
• Interface with drug substance and drug product vendors and CMOs.
• Review batch records, tech transfer reports, campaign summaries and other related CMC documents.
• Proactively monitor manufacturing processes and identify areas for process improvement and optimization; work with internal and external CMC teams to find solutions.
• Prepare written documents for regulatory submissions (e.g. INDs, CTAs, MAAs, NDAs for CMC Module 3).
• Identify and evaluate vendors and CMOs.
• Assist in site inspections and internal and external audits, as needed.
• Perform other work-related duties as assigned.

TECHNICAL KNOWLEDGE, SKILLS:

• Solid knowledge of pharmaceutical dosage forms, scale-up, and manufacturing, including validation and commercial batches.
• Experience with registration and commercial manufacturing of solid oral dosage forms.
• Experience with NDA submissions.
• Formulation experience and knowledge highly desirable.
• Solid knowledge and understanding of CMC and process development 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.

REQUIREMENTS:

• Bachelor degree, Masters degree or PhD. Preference to candidates with a strong scientific background (i.e. chemistry, pharmaceutical sciences, polymer science, engineering, formulation development).
• Minimum 7-10 years of relevant experience in a biotech/pharmaceutical company preferred. Preference to candidates with prior small company experience.   
• Requires excellent verbal and written communication skills.
• Requires problem solving and good interpersonal skills.
• Requires exceptional organizational skills with the ability to multi-task and prioritize workload based upon changing priorities.
• Requires the ability to work in a cross-functional team environment and to be a team player as well as the ability to work independently.
• Preference to energetic candidates with a desire to think “outside the box”.
• Willingness to travel periodically as needed.

JOB SUMMARY
The functional Senior / Principal Business Analyst is a member of the IT Business Solutions team. This role has domain knowledge of the Commercial Biotech business and is responsible for functional business analysis activities, including driving requirements gathering and grooming, testing, and working closely with business stakeholders and IT functions acting as subject matter expert where appropriate. This role provides ongoing process improvement, system enhancement, and typically includes systems support post-implementation.

JOB RESPONSIBILITIES

• Collaborate with various functions such as Business Systems, Project Management, and vendors to deliver solutions including process, technology, and reporting
• Own and maintain processes, documentation, and materials, while remaining compliant with internal and external regulatory guidelines
• Guide technical and architectural discussions that impacts processes and user experience
• Identify opportunities to streamline and scale processes that aligns with organizational goals
• Lead issue troubleshooting, resolve root cause, and update process and documentation to avoid similar future scenarios
• Troubleshoot complex issues and mobilize teams without direct authority
• Supervise the work of vendors and contractors to meet business needs while abiding to situational guidelines, as needed
• Manage the activities and accountable for the outcomes of complex and highly visibility efforts
• Assist oversight of the technology and process landscape for the assigned business organization(s)
• Build knowledge in Axsome’s IT solutions and the respective business organization’s end-to-end processes
• Contribute to planning, tactical execution, and operationalization of various efforts aligned with a portfolio and domain objectives, while remaining compliant with applicable regulatory guidelines
• Lead or contribute to an entire solution lifecycle through planning, selection, inception, implementation, and operation
• Participate in the creation of business and financial cases, as needed

REQUIRED EDUCATION AND EXPERIENCE

• Graduate with 8+ (10+ for Principal Business Analyst) years of experience, or Master’s degree with 3+ (8+ for Principal Business Analyst) years’ experience
• 7+ (10+ for Principal Business Analyst) years in a Business Analyst role with proven experience in technology deliveries, process mapping, and process improvement
• Experience in the pharmaceutical or biotech industry, preferably in one or more of the following areas: Commercial Operations, Sales, Marketing, Regulatory
• Excellent communication skills, including the ability to interface and influence internal and external partners at multiple organization levels
• Experience with GxP, ICH, 21CFR Part 11 regulations / systems, Annex 11, GDPR, or CCPA rules
• Demonstrated technical understanding of application architecture including various technologies and complexity such as SaaS solutions, web applications, repositories, relational databases, cloud, and reporting solutions
• Basic SQL skills to query databases and to create reports
• Strong interpersonal and negotiation skills, with a high degree of self-motivation, and ability to work independently with minimal supervision
• Ability to proactively plan, organize, deliver with limited oversight, prioritize, and quickly adapt to changing situations
• Proficient in essential tools such as Windows, Microsoft Office and/or Google Suite
• Hands-on experience operationalizing end to end business processes
• Ability to evaluate business processes, identify needs, and develop strategies to maximize opportunities for a specific business function within Axsome
• Experience in Technology Release Management for SaaS applications
• Experience with one or more of the following tools: Veeva, BI tools, ERP, HRIS