Darcy Weyant
Leesburg
Summary
Highly motivated Associate Director of Clinical Supply with a strong passion for playing a vital role in the research, development and execution of new therapies and treatments for patients in need. Dedicated professional with a keen eye for detail and a track record of optimizing processes and collaborating with cross-functional teams. Experienced in managing clinical supply chain operations, ensuring timely delivery of materials and resources to support clinical trials. Thrives in fast-paced environments and excels at driving efficiency and quality.
Overview
13
13
years of professional experience
Work History
Associate Director, Clinical Supply
REGENXBIO
03.2022 - Current
- Oversee and manage all aspects of clinical supply chain operations including FDP to BDS planning, forecasting, sourcing, packaging, labeling, and distribution for eight gene therapy clinical trials (opthalmology & pediatric rare disease focused)
- Develop and implement strategies to optimize inventory levels, minimize waste, and ensure on-time delivery of clinical supplies to investigators and sites
- Supply scope includes over 200 sites and approximately 1,000 shipments a year
- 100% on time delivery of all clinical trial materials
- Identified and mitigated COVID-19 supply chain risks related to drug and material shortages and distribution challenges
- Collaborate with cross-functional teams including Clinical Operations, Regulatory Affairs, Quality Assurance, CMC leads, and CROs to support clinical trial timelines and goals
- Provide ongoing site and PI training on storage best practices and temperature excursion management
- Manage relationships with external vendors, CMOs, CPOs, and logistics partners to ensure quality, cost-effective, and timely delivery of clinical trial materials
- Designed IRT Specifications, perform UAT and coordinated on-time go-live
- Prepare and present clinical supply chain updates to senior/executive management, providing insights on supply, risk/mitigation management and partnership management
- Author pharmacy manuals, packaging, and labeling plans for all eight studies
- Reviewed proposed regulatory and protocol changes and evaluated potential impacts on business operations.
Senior Manager, Clinical Supply
REGENXBIO
07.2021 - 03.2022
Senior Manager, Enterprise Risk, Compliance and Business Process Improvement
REGENXBIO
12.2018 - 07.2021
- Created first cross-functional ERM program at REGENXBIO
- Led cross-functional teams in designing and implementing risk management strategies to enhance overall operational efficiency and mitigate potential threats
- Conducted regular assessments to identify potential risks and assessed and implemented appropriate mitigation controls
- Presented top risks and mitigations to the Audit Committee and Board of Directors quarterly
Manager, Risk & Compliance
REGENXBIO
12.2017 - 12.2018
Senior Accountant
REGENXBIO
08.2015 - 12.2017
Assurance Associate
PricewaterhouseCoopers LLP
06.2012 - 06.2015
Education
Master of Accounting and Information Systems -
Virginia Tech
Blacksburg, Virginia12.2012
Bachelor of Science in Business Administration - Accounting
East Carolina University
Greenville, North Carolina12.2011
Skills
- Clinical forecasting
- Risk management
- Project management
- Cross functional communication
- Process improvement
- Finance
- Excursion management
- Verbal and written communication
Accomplishments
President's Award, CEO, 12/01/19
Timeline
Associate Director, Clinical Supply
REGENXBIO
03.2022 - Current
Senior Manager, Clinical Supply
REGENXBIO
07.2021 - 03.2022
Senior Manager, Enterprise Risk, Compliance and Business Process Improvement
REGENXBIO
12.2018 - 07.2021
Manager, Risk & Compliance
REGENXBIO
12.2017 - 12.2018
Senior Accountant
REGENXBIO
08.2015 - 12.2017
Assurance Associate
PricewaterhouseCoopers LLP
06.2012 - 06.2015
Bachelor of Science in Business Administration - Accounting
East Carolina University
Master of Accounting and Information Systems -
Virginia Tech
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