Jessica Nguyen

• Oversaw CROs in North America, Europe, Japan, and China to ensure analytical testing services fostered approval of new oncology treatments.
• Drove and coordinated cross-functional team throughout implementation, execution, and closure of 20+ global clinical trials empowering them to meet contracted deliverables, including issue management, contingency planning, and issue resolution.
• Served as a single point of contact and central owner for trial communication to and from pharmaceutical partners, CROs, and regional clinical operations for entire clinical program.
• Supported business development activities including due diligence meetings with potential clients and ensuring quality services are delivered timely within scope and budget to maintain strong client relations.
• Streamlined contract management processes for results reporting, sales orders, inventory control, and billing by automating upload from LIS to ERP.
• Presented high-level status of clinical program to stakeholders and provided input for new strategies to improve efficiency and reduce risk.

• Developed project plans for on market and new product development including managing scope, scheduling, resources, risk identification and mitigation, design verification and validation, design transfer.
• Optimized project schedules by identifying critical path and driving cross-functional team to execute tasks that can be done in parallel.
• Presented project timelines, status updates, major risks and mitigation plans, and plan deviations to key stakeholders and executive team.
• Led daily meetings with cross-functional team to drive deliverables and to facilitate problem solving to address issues with subject matter experts.
• Contributed to managing cross-functional team (including Regulatory, Labeling, Quality, Marketing, Operations, Analytical, Reagents, R&D, Manufacturing Engineering, Software Engineering, and Systems Engineering) following new product development gate phase processes from feasibility to commercialization in EU (IVDD/IVDR) and FDA 510(k) submission (K202101).
• Led new feature development software upgrade project utilizing Jira to manage sprints and design change phase gate processes from conception to launch.
• Developed and maintained design history files for R&D projects to ensure design control procedures were documented according to GDP standards.
• Managed team of 10+ engineers and regulatory specialists to ensure blood diagnostic devices conform to latest RoHS 3 Directive (EU 2015/863).
• Implemented new process to automate and analyze KPI reports for manufacturing failure rates to kickoff project scope to key stakeholders and led on-market hardware design change projects for obsolete parts to prevent line down.

Clinical Project Management

• Focused on clinical development plan for digital therapeutic with FDA Breakthrough Device designation.
• Designed clinical pilot study to test the effectiveness of digital therapeutic device on the behavioral and psychological symptoms of dementia.
• Assisted in development of IRB and FDA documents.
• Managed clinical site and team during development and roll-out of clinical pilot study.
• Established specific outcome measurements for clinical trial to target research goals.
• Drafted scripts and participant letters to provide guidelines on what to communicate with patients.
• Monitored project budget through careful assessment of resource usage and task management to ensure low costs.

Scientific and Government Affairs

• Developed digital therapeutic device’s claims and figures from clinical trial data and published research for FDA pre-submissions.
• Researched and wrote about prevalence of dementia, its cost to society and government, and how its behavioral symptoms can be mitigated with digital therapeutic device in 200-page product memorandum shared with potential pharmaceutical partners.
• Led investor meetings with Eli Lilly to negotiate a partnership in the US market.
• Created dementia patient’s journey and clinical development plan that was used in investor presentations.
• Evaluated innovative reimbursement approaches for market access in senior care and Alzheimer's/dementia sectors.
• Performed market analysis and competitive analysis of the digital therapeutic and drug market competitors on existing and emerging treatments.
• Forecasted market profitability for emerging markets and Europe based off of dementia drug consumption and health economics.

• Efficiently answered multi-line phone and processed high volume of enrollment inquiries from patients and health care providers.
• Created and maintained accurate and confidential patient files according to HIPAA regulations.
• Evaluated patient data to determine and implement the appropriate course of action for each individual's needs through insurance coverage and pharmaceutical assistance programs.
• Educated patients about insurance coverage, copays, deductibles, benefit maximums, and out of pocket maximums.
• Collected adverse event information from patients, caregivers, and health care professionals to report adverse drug experience (ADE).