Associate Director, Medical Affairs Research (Investigator Sponsored Studies)
Core
Overseeing systems, processes, and daily operations of the Investigator Sponsored Studies (ISS) program in Medical Affairs, ensuring compliance with regulations and industry guidelines.
Role type
Associate Director, Medical Affairs Research (Investigator Sponsored Studies)
Builds
ISS and research collaboration programs, including strategy, process enhancements, and annual medical planning.
Domain
Pharmaceutical/Biotech industry, Medical Affairs, Research Management
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
ISS and research management, strategy development, process improvement, budget management, contract management, training on request management systems, team leadership, metric reporting, knowledge of medical/regulatory affairs guidelines (FDA, ICH-GCP, IRB, Sunshine Act), ISS request management systems
Preferred skills
Previous ISS/research management experience, supervisory/management experience, project management, problem-solving, initiative, Microsoft programs (Word, PowerPoint, Excel, Teams, PowerBI), online meeting platforms (Zoom, Teams)
Technologies
Microsoft Word, PowerPoint, Excel, Teams, PowerBI, Zoom
Responsibilities
Lead ISS and research collaboration programs including strategy and process enhancements; Manage strategy and areas of interest development for disease areas; Participate in ISS Committee meetings; Engage with external applicants and internal stakeholders; Develop and track annual budgets; Establish and lead training on request management systems; Lead Vertex Research Award Programs; Create and expand metric reports for Grants, Sponsorships, and ISS; Manage team of direct reports
Seniority
Senior, hands-on IC with management responsibilities
