Wendy Talbott
Stonington,CT
Summary
Experienced clinical operations professional with 20+ years in clinical research and project management, focusing on global clinical trials and risk management. Oversaw a $400 million budget for three Phase III clinical trials at GSK. Achieved rapid enrollment of 15,000 COVID trial participants in two weeks, leading to significant study timeline improvements. Seeking Clinical Operations Leadership role at an innovative company to utilize expertise in trial execution and team building for advancing patient care.
Overview
29
29
years of professional experience
Work History
Consultant
Coastal Clinical Research Consulting, LLC
12.2024 - Current
- Overseeing MOH and EC submissions for closure of projects.
- Conducted risk assessments for business processes, recommending measures to mitigate potential impacts for closing program(s).
- Gathered, organized and input information into digital database.
- Overseeing additional data requests for manuscripts.
- Ensuring the closure of final sample delivery to external labs and samples allocated for destruction.
Vice President, Clinical Operations
HilleVax
10.2021 - 12.2024
- Developed clinical trial strategy, driving innovation in operational excellence while cultivating a high performing team to meet ambitious corporate goals.
- Recruited, trained, and mentored two-tier clinical operations team.
- Built an arm of operations establishing an oversight management role to oversee the monitoring of the clinical trials.
- Fostered cross-functional partnerships, aligned internal and external teams and stakeholders to streamline clinical operations and accelerated program timelines.
- Directed risk management strategies safeguarding company assets and ensuring compliance standards.
- Cultivated strong relationships with clients, vendors, and partners for mutually beneficial collaborations by establishing Governance models.
- Facilitated timely decision-making through accurate data analysis and insightful reporting on key operational metrics.
- Recruited, trained, and led employees, boosting productivity and increasing efficiency by 30% through implementation of best practices.
Senior Director, Clinical Operations
Novavax
07.2020 - 10.2021
- Provided oversight to Flu program; build a team and managed the team working on the COVID program, working in tandem with the Vaccine Taskforce in the UK and Operation Warp Speed.
- Established the infrastructure in medical affairs in anticipation of approval to automatically shift into MA for further assessment, trials, ad hoc activities needed after vaccine approval
- Executed study start-up in 4 weeks managing the change in subject allocation for the changing COVID landscape from 3K to 6K to 15K subjects.
- Optimized project timelines by effectively delegating tasks and prioritizing workload among team members.
- Provided oversight for 6 labs for the COVID trial in the UK.
- Developed specific project risk management plans, implementing novel strategies to optimize trial execution and resource allocation
- Increased employee satisfaction, providing regular coaching and feedback sessions.
- Worked with the team to navigate the complex regulatory environment during COVID to ensure compliance with local laws, standards, and regulations relevant to the business domain.
Director, Operational Oversight
Takeda Pharmaceuticals U.S.A. Inc
06.2018 - 07.2020
- Part of the team that produced effective SOPs by assessing both sets of procedures and determining the best path forward after the Takeda merger with Shire
- Directed global clinical programs and led program leads and project managers to execute trials within vaccine programs
- Oversaw early engagement processes, ensuring proper implementation of the Vaccine Business Unit operating model.
- Provided clinical operations expertise for study management plans, risk management, and financial planning.
- Managed a team of 15+ in 3 difference geographic locations (US, Switzerland and Singapore).
Associate Director Project Management/Delivery
PPD
02.2015 - 06.2018
- Project lead for the pandemic flu program for Moderna, provided oversight for their vaccine mRNA program.
- Facilitated the establishment of preferred laboratory vendors across Australia, the EU, and the US; conducted operational audits and contributed to the selection of two new laboratories for PPD (Thermo Fisher).
- Selected to join a specialized team that developed a proposal for establishing a dedicated Vaccine business unit, composed of project managers with expertise in vaccine research, to conduct clinical trials for vaccine sponsors. The proposal received senior leadership approval in 2018.
Manager, CIA Vaccine Annual Planning
GlaxoSmithKline
06.2013 - 02.2015
- Managed the Corporate Integrity Agreement (CIA) with the Office of Inspector General (OIG) for all U.S.-approved products across Research, Publications, and Marketing. Led quarterly audit preparations and underwent OIG audits with no findings reported for vaccines.
Sr. Global Study Leader
GlaxoSmithKline
06.2007 - 06.2013
- Served as the primary operational contact for all country sites involved in two large Phase 3 studies: a 25,000-subject elderly influenza vaccine trial and a 30,000-subject shingles study across two protocols, which contributed to the licensure of the Shingrix vaccine. Managed budgets exceeding $300 million for both programs.
Operational Program Manager - Flu Franchise Lead
GlaxoSmithKline
08.2001 - 06.2007
- Served as the operational lead for the Flu program, overseeing the study that secured U.S. approval of GSK's Flu vaccine that was given fast track status for the 2005-06 flu season.
Medical Program Coordinator
Aventis Pasteur Inc.
06.1996 - 08.2001
- Established operational processes, including budget management, and workflows for all post-licensure study commitments. Served as the primary liaison for Marketing and Clinical Affairs concerning Medical Affairs activities and budgets. Oversaw all vendor relationships and medical writing deliverables.
Education
Bachelor of Science - Psychology
Frostburg State University
Frostburg, MD06.1990
Skills
- Global study experience
- Budget negotiation and oversight
- Verbal and written communication
- Rapid Study Start
- Process & Compliance
- Regulatory Audits (Global)
- Vendor Oversight
- High emotional intelligence
- Issue resolution and governance
- Client engagement
- Collaboration with external partners
- Team building, leadership and development
LANGUAGES
English Native
Accomplishments
- Enhanced Stakeholder Communication: Improved stakeholder communication by 40%, enhancing project success rates through effective engagement strategies.
- Effective Vendor Management: Managed 10+ vendors, ensuring timely deliverables and alignment with clinical trial objectives to maintain project timelines.
- Optimized Project Delivery: Achieved a 25% increase in project completion rates, optimizing vendor coordination and stakeholder engagement strategies.
FIND ME ONLINE
LinkedIn: https://www.linkedin.com/in/wendy-t-02bba27/
Awards and Recognition
GlaxoSmithKline
R&D Recognition Award (Silver Award) Fluarix
US Pharmaceutical Spirit Award Fluarix
R&D Recognition Award (Bronze Award) Kinrix
R&D Recognition Award (Bronze Award) Shingrix
PPD Inc.
CEO Team Excellence Award – Vaccine Leadership Team
Timeline
Consultant
Coastal Clinical Research Consulting, LLC
12.2024 - Current
Vice President, Clinical Operations
HilleVax
10.2021 - 12.2024
Senior Director, Clinical Operations
Novavax
07.2020 - 10.2021
Director, Operational Oversight
Takeda Pharmaceuticals U.S.A. Inc
06.2018 - 07.2020
Associate Director Project Management/Delivery
PPD
02.2015 - 06.2018
Manager, CIA Vaccine Annual Planning
GlaxoSmithKline
06.2013 - 02.2015
Sr. Global Study Leader
GlaxoSmithKline
06.2007 - 06.2013
Operational Program Manager - Flu Franchise Lead
GlaxoSmithKline
08.2001 - 06.2007
Medical Program Coordinator
Aventis Pasteur Inc.
06.1996 - 08.2001
Bachelor of Science - Psychology
Frostburg State University
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