HDT Global

Director

• Report directly to the Vice President, Medical Affairs
• Build and lead the Medical Science Liaison (MSL) teams
• Collaborate with therapeutic area Medical Directors to develop field medical strategy and tactics in support of Medical Affairs (MA) goals
• Provide support across REGENXBIO’s clinical development programs for the neuromuscular/DMD program
• Assist with planning and executing advisory boards
• Manage KOL advisors
• Provide medical support at congresses
• Design and build a high-functioning MSL organization
• Recruit and coach / mentor MSLs for high performance
• Oversee thought leader mapping and KOL engagement strategy planning
• Establish relationships with national thought leaders and investigators
• Ensure development, and maintenance of resources for the MSL teams
• Lead field insights, initiatives, and competitive intelligence activities
• Assist with congress strategy, planning and logistics
• Maintain scientific and clinical knowledge in the therapeutic areas
• Contribute to MA projects as assigned
• Required to travel 50%-70% of the time

Director, Medical Science Liaisons – Neuromuscular, DMD

Research Analyst

• Support and coordinate logistical aspects of clinical trials (start-up, conduct, close-out)
• Assist in the development and editing of study-related materials (consent forms, study binders, site study aids)
• Assist with preparation of training workshops, Investigator/Advisory Board meeting materials
• Develop study tracking tools (site lists, enrollment tracking, vendor spreadsheets) and maintain tracking spreadsheets/databases
• Provide routine reports/dashboards to study team members
• Request purchase orders independently and assist in invoice review with CPM oversight
• Track essential documents and maintain/review the eTMF under guidance of CPM
• Assist with management of investigational product and study supplies, ensuring accuracy of shipments and collection of regulatory documents for IP release
• Attend co-monitoring visits or other site visits based on experience and CPM guidance
• Assist CPM with clinical database review and facilitate resolution of queries
• Collect, review and file regulatory and other essential documents from clinical personnel and sites
• Distribute meeting agendas and prepare/distribute meeting minutes with action items
• May assume specialized administrative roles (e.g. SOP Administrator)
• Travel up to 5% of the time

Clinical Research Associate

Administrative Assistant

• Provide proactive administrative support to the CCPO, including calendar management, travel coordination, and meeting prioritization
• Act as a liaison between executives and internal/external stakeholders
• Serve as the gatekeeper for the CCPO, prioritizing requests and ensuring timely follow-up
• Assist in the new hire onboarding process including creating employee files, triggering background screenings, and checking new hire paperwork
• Support contractor process, working closely with Finance, Legal, and hiring managers on process and administration of purchase orders/SOWs
• Support onsite interview process including scheduling and day-of coordination
• Oversee termination process including termination paperwork, exit surveys, and tracking effective dates
• Prepare and circulate weekly notifications for new hires and terminations
• Maintain electronic employee files, ensuring quality, completeness, and integrity of information
• Assist with employee benefits, including reconciling and processing benefits bills as needed
• Assist with planning and execution of culture and corporate-building activities such as employee events and celebrations
• Be an engaged member of the admin team, providing backup coverage as needed
• Manage sensitive and confidential employee information and Board of Directors materials with discretion

Director, Medical Science Liaisons – Neuromuscular, DMD

Clinical Research Associate

Administrative Assistant to the Chief Communications and People Officer