Axsome Therapeutics is seeking an Associate Director, Medical Education and External Research to oversee and drive strategic alignment of all Axsome Medical Affairs external educational and investigator-sponsored trials (ISTs) activities, addressing critical gaps in care within the central nervous system (CNS) field.
Requirements
- 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)
- Experience with educational grant and research management systems (e.g., CyberGrants)
- 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
- Demonstrated expertise in development and execution of medical education strategies is desired
Responsibilities
- In collaboration with Medical Affairs colleagues, develop and implement medical education and external research/IST objectives and annual plans for all Axsome therapeutic areas
- 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
Other
- This is a cross-functional leadership role, and this individual will be a member of Medical Core Teams for multiple programs.
- The Associate Director will establish and maintain strong relationships with internal and external stakeholders including investigators, HCPs, vendors, and cross-functional team members.
- Occasional travel (up to 20%) for conferences and meetings
- Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles.
- Proven skills in negotiation, influencing without authority, managing through ambiguity, and working diplomatically through conflict
