For the safety of our employees and communities in response to COVID-19, ACADIA has implemented a temporary work from home policy. As a part of this shift, we have migrated all interviews to virtual interviewing via phone and video.
Responsible for the review and rendering of decisions related to grants for continuous medical education, investigator-initiated trials, and medical sponsorships as well as provide oversight of supported activities within assigned therapeutic areas of interest. Also, serve as process manager for charitable donations to support Patient Assistance Programs operated by independent non-profit charitable foundations and organizations.
- Manage and serve as primary contact for Investigator Initiated trial program. Serve as primary contact for external thought Leaders, principal investigators, research pharmacist, study coordinators and internal teams as it relates to the management and execution of IIT program
- Forecast budget, milestone payments, track milestone payments, and invoicing
- Provide operational advice and guidance to cross functional teams to ensure IIT’s meet compliance requirements and business goals
- Ensure study documentation from investigators is complete and accurate to meet internal and external standards
- Negotiate contracting terms (milestone distributions) with investigators, educational providers, suppliers and other service providers
- Interpret protocols to determine clinical/commercial drug requirements, labeling, subject kit configuration and distribution strategy
- Manage and monitor study site requirements including, P-IND submissions, IRB approvals, drug supply and re-forecasting, enrollment verification, publication review
- Evaluate data from IIT studies and inform internal groups, including legal, field medical, medical information, and IIT team, regarding new data and key communications
- Ensure studies have been evaluated for any creation of Intellectual property by Acadia legal
- Liase with cross-functional IIT team, including Legal, Drug Supply, Regulatory, PV and MSL’s in the execution and management of the program
- Collaborate with field MSL team, on the management and supervision of IIT studies
- Manage and serve as primary contact for Medical Education Grant Program. Work with education providers, Internal team
- Serve as primary contact for Independent Charity Committee (ICC) and manages the process for charitable donations to support Patient Assistance Programs operated by independent non-profit charitable foundations and organizations
- Manage and serve as primary contact for Medical Affairs Sponsorships
- Continuous process assessment to identify areas for improvement with implementation of solutions such as software enhancements for improved management and visibility of the programs
- Develop monthly and quarterly reports, analysis of IIT/MedEd program results and performance metrics
- Development and revision of standard operating procedures
- Bachelor’s degree in a scientific field or an equivalent combination of relevant education and applicable job experience
- Minimum 8 years of progressively responsible relevant experience including: Experience facilitating cross-functional project teams
- Participation in cross-functional project management activities
- Late stage drug development/NDA experience preferred
- Must possess: An understanding of the drug development process and the principles, concepts, practices, and standards of pharmaceutical project management. Familiarity with FDA and/or European Medicines Agency (EMA) Regulations
- Ability to support multiple project teams simultaneously, be well organized and have strong time management skills and attention to detail
- In-depth knowledge and skill with Microsoft PowerPoint, Microsoft Word, Microsoft Excel, and other reporting and tracking/process tools (i.e., Smartsheet’s, Visio)
- Familiarity with grant tracking systems (Vision Tracker, DataVision, etc.
- Excellent interpersonal, organizational, written and verbal communication skills
- Ability to work under limited supervision, determine personal work plan, and schedule tasks and activities accordingly
- Ability to accommodate shifting priorities, demands and timelines. Ability to elicit cooperation from a wide variety of functions
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds.
ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity