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

About This Role 

Axsome Therapeutics is seeking a Manager/Senior Manager of External Education and Research. The Manager/Sr. Manager of External Education and Research has oversight and drives strategic alignment of all Axsome Medical Affairs external educational (e.g., symposia, grants) and investigator-sponsored trials (ISTs) activities. This is a cross-functional leadership role, and this individual will be a member of Core Medical Teams for multiple programs. The Manager/Sr. Manager of External Education and Research is an experienced leader with expertise in developing and executing annual plans for independent medical education (IME) and IIS activities.

The Manager/Sr Manager will establish and maintain strong relationships with internal and external stakeholders including, investigators, HCPs, vendors, and cross-functional team members. The Manager/Sr. Manager will have additional operational, project management responsibilities in support of the Scientific Affairs Team within Medical Affairs (e.g., budget tracking and management, dashboard creation and maintenance, metrics, and reporting). Therapeutic area experience in neuroscience (e.g. psychiatry or neurology) is highly desired.

This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles. 

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

• Work in collaboration with Medical Affairs colleagues to develop medical education and external research/IST objectives and annual plans for all Axsome therapeutic areas
• Lead and work cross functionally with internal and external colleagues, including legal, compliance, finance, accounts payable, Regional Medical Affairs, etc.
• Contribute to the development and refinement of the IME and external research/IST framework and SOPs to ensure a robust and compliant process for review and management of IME programs and external research studies
• Manage and evaluate all incoming IME grant requests and external research/IST proposals and assess for appropriateness and compliance with Axsome criteria, policies and procedures
• Lead development and implementation of the Educational Grant Review Committee and External Research Collaborations Committee structures Lead internal review committee meetings for the endorsement and approval of IME programs and management of external research/IST studies
• Lead negotiation of education and research agreements and statements of work (including changes of scope where applicable)
• Manage reconciliation process of all medical education providers in collaboration with compliance team to ensure timely reporting per Sunshine Act
• Provide operational support for external research studies, including oversight of contract compliance, management of payments, provision of drug supply, and management of study progress reports
• Manage educational grant and external research budgets across all therapeutic areas and report accruals to accounting according to the financial schedules
• Manage all financial and contractual aspects of assigned projects, including vendor relationships
• Lead operational efficiencies and enhancing day-to-day practices and processes for optimal decision making and collaboration across the IME and external research functions including timely achievement of short to long term deliverables
• Liaise with internal and external stakeholders to ensure timely communication of approved IME and research activities, study progress, and delays 
• Maintains current knowledge of relevant information sources and key continuing medical education and external research landscape events which may impact IME and/or external research policies and procedures
• Participates in training and understands policies from Axsome compliance to ensure supported educational programs and research activities are consistent with guidelines (e.g., ACCME, PhRMA, EACME, OIG, FDA)
• In collaboration with Scientific Affairs Team Leadership, create function and project-specific dashboards and develop KPIs/metrics for each function. Lead operational excellence initiatives for the Scientific Affairs Team

Requirements / Qualifications

• Bachelor’s degree required, preferably in a health-related field. Master’s degree or higher preferred. CNS experience highly preferred
• Minimum 3 years of experience within the Pharma/Biotech industry focused on external education and research activities, including contracting and vendor oversight
• Demonstrated understanding of the legal and regulatory guidelines (e.g., PhRMA, ACCME, Sunshine Act, etc.) associated with independent medical education, pharmaceutical industry research, and external granting functions and the ability to use knowledge to make sound operational decisions
• Knowledge of CME/CE outcomes assessment models (e.g., Moore’s levels)
• Occasional travel (up to 20%) for conferences and meetings
• Ability to work onsite Monday, Tuesday, and Thursday

Experience, Knowledge and Skills

• Knowledge of instructional design principles as they pertain to IME is preferred
• Experience with educational grant and research management systems (e.g., CyberGrants, iEnvision IST)
• Experience working with spreadsheets (e.g., Excel, Smartsheets)
• Data analytics and dashboard creation using visualization software (e.g., Power BI) is desired
• Experience managing vendors
• Excellent verbal and written communication skills
• Demonstrated expertise in development and execution of medical education strategies is desired.
• Proven skills in negotiation, influencing without authority, managing through ambiguity, and working diplomatically through conflict.
• Flexible and able to work independently in a fast-paced, rapidly changing environment on multiple projects efficiently.

Salary & Benefits (HR will complete)

The anticipated salary range for this role is $100,000 - $130,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.

Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.

Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.