Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for central nervous system (CNS) conditions that have limited treatment options.Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions. At Axsome, we are intensely committed to developing products that meaningfully improve the lives of patients and provide additional therapeutic options for physicians.

Axsome Therapeutics, Inc.

QA Engineer

Quality Assurance Specialist ensuring compliance at Axsome Therapeutics for CNS therapies.

• Axsome Therapeutics is seeking a Quality Assurance Specialist/Senior Specialist
• Focus on ensuring compliance with Good Manufacturing Practices (GMP)
• Oversee external manufacturing activities to ensure consistent compliance with procedures

Specialist, Quality Assurance

Sales

Director of Sales Operations; support CNS therapies product launches at Axsome Therapeutics.

• Support commercial product launches
• Manage sales operations processes
• Ensure field teams maximize data use
• Manage field compliance operations
• Lead a team for best operations

Director, Sales Operations

Operations

Axsome seeks Director of Drug Product Technical Operations to manage manufacturing relationships.

• Develop and implement strategic plans for drug product development and manufacturing goals
• Oversee drug product manufacturing processes for efficient operations
• Author process validation protocols and reports for commercial products
• Facilitate technology transfer from R&D to manufacturing
• Review commercial batch records and investigations related to manufacturing deviations
• Collaborate with cross-functional teams to ensure successful product launch
• Maintain in-process control strategy and continued process verification (CPV) program
• Author comprehensive CPV protocols and analyze data for improvements
• Implement best practices and process improvements in manufacturing
• Participate in process validation activities and statistical analysis
• Provide expertise for regulatory submissions related to drug product manufacturing
• Manage relationships with contract manufacturing organizations (CMOs)
• Collaborate with QA for CMO audit support

Associate Director/Director, Drug Product Technical Operations

Manager for QA systems at Axsome Therapeutics, a biopharmaceutical company.

• Support development, implementation, and improvement of corporate quality management systems
• Assist with management and development of electronic quality management systems
• Develop and implement a comprehensive supplier qualification program
• Conduct assessments of suppliers for regulatory adherence
• Lead investigations of product quality complaints
• Monitor Quality Systems via metrics
• Conduct GMP audits of external CMOs and labs
• Audit internal processes for SOP adherence
• Serve as escalation point for quality issues
• Review and approve internal change controls
• Maintain inspection readiness for QMS
• Author and revise SOPs, Work Instructions, and controlled documents
• Follow through on corrective actions from deviations
• Escalate serious compliance issues to senior management
• Maintain knowledge of GxP requirements and impacts on SOPs

Manager, QA Systems 

Marketing

Lead Payer Marketing at Axsome to enhance access to CNS therapies.

• Drive Payer Marketing efforts
• Ensure access to innovative medicines
• Collaborate cross-functionally with teams to develop payer marketing strategy
• Lead the payer marketing team
• Create payer marketing narratives and resources
• Leverage data and insights for compelling narratives
• Work closely with Account team and Market Research
• Partner with HEOR team for value messaging to payers
• Serve as point of contact with Brand team
• Manage multiple projects requiring cross-functional buy-in
• Manage agency efforts ensuring project quality and compliance


Executive Director, Payer Marketing

Recruitment

• Lead strategic initiatives for trial-specific patient recruitment and retention efforts for assigned clinical studies during study start-up
• Develop study-specific recruitment materials and assess feasibility of central recruitment campaigns
• Identify and evaluate recruitment vendors that offer innovative solutions or approaches and oversee the selection and oversight in collaboration with the clinical team
• Work cross-functionally in the review and approval of study and site-specific recruitment materials
• Monitor weekly enrollment metrics and work alongside the clinical team to meet/exceed enrollment goals for assigned studies
• Establish application of best practices and lessons learned across all clinical studies
• Track, analyze, and present data from central recruitment campaigns
• Attend internal and external meetings and provide updates on recruitment activities
• Assist with developing content such as newsletters and presentations
• Liaise with clinical sites to evaluate site-specific recruitment initiatives and determine the potential ROI, along with clinical team
• Manage the recruitment budget for assigned clinical studies
• Perform outreach as necessary for underperforming clinical sites to evaluate enrollment goals. Proactively develop solutions and communicate feedback to clinical team

Senior Specialist, Clinical Trial Recruitment

• Strategic Training Leadership: Spearhead Axsome’s learning and development strategy, creating a roadmap, and implementing programs that cultivate the necessary talent and skills to achieve our strategic long-term objectives across a diverse portfolio of innovative products
• Team Management and Development: Lead and manage a training team, providing guidance, mentorship, and support. Fostering a collaborative environment that encourages skill development and knowledge sharing
• Workshops and Train-the-Trainer Sessions: Oversee the planning and development of workshops, both at the national and regional levels. Conduct “train-the-trainer” sessions to empower internal trainers with the necessary skills to deliver effective training
• Frontline Leadership Development: Take the leading role in the development and execution of frontline sales leader training and development initiatives
• Learning Management System (LMS) Proficiency: Ensure seamless integration of training materials and assessments within the LMS
• Collaboration and Compliance: Collaborate with cross-functional partners, including Medical, Regulatory, and Legal teams, to support development, approval and execution of training programs and resources, ensuring compliance with company policy as well as industry regulations and guidelines

Senior Director, Sales Training and Development

Manage sales training and development at Axsome Therapeutics for CNS therapies.

• Facilitate training programs for Axsome Specialty Account Managers, focused on enhancing product knowledge, selling skills, and customer engagement
• Ensure that sales teams are well-prepared to effectively communicate product features, benefits, and clinical data to healthcare professionals
• Collaborate with cross-functional teams (such as Medical Affairs, Marketing, and Regulatory) to align training content with product strategies and compliance requirements
• Manage our LMS platform to efficiently deliver training content and ensure seamless integration of training materials and assessments within the LMS
• Lead training efforts during product launches, ensuring that sales teams are equipped to effectively introduce new products to the market
• Collaborate with cross functional partners to create and maintain learning tools, playbooks, and resources
• Train sales representatives on the effective use of digital platforms, CRM systems, and presentation materials
• Stay informed about industry regulations and guidelines related to pharmaceutical sales and marketing, ensuring that all training content adheres to compliance standards and ethical practices
• Collaborate with other training managers or external vendors to leverage industry best practices

Senior Manager, Sales Training and Development 

• Lead the development of training content for products
• Facilitate training programs
• Ensure sales teams are well-prepared
• Coordinate with regional trainers
• Manage LMS platform
• Lead training efforts during product launches
• Train sales reps on digital platforms and CRM systems
• Stay informed about industry regulations
• Collaborate with other training managers or external vendors

Associate Director, Sales Training and Development 

Associate Director of Sales Operations at Axsome Therapeutics, focusing on CNS disorders.

• Manage sales operations processes
• Oversee HCP engagement plans
• Maximize data and technology use
• Ensure field compliance operations
• Lead operations team

Axsome Therapeutics, Inc. Jobs in New York City