Business Development, Strategic Projects, Rare Disease Clinical Trials
Portland , Oregon, Us
Manage consultancy providing expertise to pharmaceutical companies developing treatments in rare diseases. Point of contact for more than 30 global clients; build project scope, budget, estimate, contract; develop and execute project deliverablesHighlights:–Directed Neurocognitive Master Class with more than 80 participants from academic/hospital sites in 12 countries. Oversaw development of online content, learning objectives, learning management system, multiple live sessions, faculty and speaker participation (including MD KOLS and FDA). Managed budget, staff, outcome report.– Developed materials for international trainings for assessors conducting neurocognitive tests in rare disease clinical trials. Coordinated with trainers and hospital sites to execute training.– Led the planning, sponsorship, budget, consensus procedures development, and contracting for an international consensus conference to address cognitive endpoints in mucopolysaccharidosis. Directed steering committee of 12 key opinion leading physicians and neuropsychologists. Managed all logistics for workshops and panel deliberations. Brought more than 60 experts together from around the world, eighteen pharmaceutical companies, EMA and FDA representatives. Coordinated the production of subsequent academic publications and authored poster"Jennifer was instrumental in leading our LLC’s effort in bringing together patient advocacy organizations, regulators (EMA, FDA), academia, and industry partners for a key international scientific meeting to discuss critical trial endpoint considerations for drug development programs in rare diseases. This was highly complex, with stakeholders from across multiple groups, and Jennifer orchestrated the program with precision managing the technical aspects and also balancing that with the multiple critical relationships with the meeting participants."