Clinical Research Experience
Wendy Talbott
Stonington,CT
Summary
Accomplished global operations leader with a strong history of building high-performing teams and leading cross-functional initiatives. Skilled in strategic planning, resource management, and performance oversight. Recognized for cultivating collaboration, influencing stakeholders at all levels, and delivering results across global programs.
Overview
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Work History
Consultant
Coastal Clinical Research Consulting, LLC
12.2024 - Current
- Advise biotech clients on strategic planning, program closure, vendor alignment, and regulatory submissions, serving as a trusted partner across functions.
- Delivered compliant project closeouts across 5 programs, improving client satisfaction and driving repeat business.
- Align project deliverables with client objectives, ensuring operational efficiency and adherence to timelines.
Vice President, Clinical Operations
HilleVax
10.2021 - 12.2024
- Scaled and led a high-performing operations team, aligning organizational design with business strategy to support multiple new product launches.
- Managed multi-million-dollar budgets while balancing cost efficiency with service quality and risk mitigation.
- Established performance monitoring frameworks and compliance systems, enhancing operational accountability and decision-making.
- Partnered with cross-functional stakeholders to drive program delivery, streamline processes, and resolve complex operational challenges.
Senior Director, Clinical Operations
Novavax
07.2020 - 10.2021
- Built infrastructure and service support models for new vaccine programs, ensuring rapid readiness for launch.
- Managed global service delivery under accelerated timelines, scaling resources to meet demand (3,000 → 15,000 subjects).
- Oversaw six vendor labs in the UK, maintaining quality and compliance in dynamic field environments.
- Developed and implemented coaching programs for technical staff, improving team effectiveness and operational efficiency.
Director, Operational Oversight
Takeda Pharmaceuticals U.S.A. Inc
06.2018 - 07.2020
- Designed organizational frameworks and SOPs post-merger to standardize study delivery across global regions.
- Led field-based teams across 3 continents, ensuring operational consistency, compliance, and high customer satisfaction.
- Directed financial planning and resource allocation, optimizing operational efficiency and supporting business objectives.
Associate Director Project Management/Delivery
PPD
02.2015 - 06.2018
- Collaborated with cross-functional teams to enhance global service delivery infrastructure.
- Proposed and launched a new vaccine services business unit, securing executive approval and operational support.
- Oversaw global training programs, audits, and vendor partnerships, ensuring seamless and compliant service delivery.
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.
Skills
Trusted, values-driven leader
Strong Interpersonal and Communication Skills
Organizational Design, Team Scaling & Training Programs
Financial Management & Resource Allocation
Performance Metrics & Risk Management
Strong Leadership in a Matrix Environment
Education
Bachelor of Science - Psychology
Frostburg State University
Frostburg, MD06.1990
LANGUAGES
English Native
Accomplishments
- Enhanced Stakeholder Communication: Improved stakeholder communication by 40%, enhancing project success rates through effective engagement strategies and governance.
- Effective Vendor Management: Established monitoring oversight processes across 2 companies. Enabled proficient management of over 10 + ensuring timely deliverables and alignment with clinical trial objectives to maintain project timelines based on KPIs and data analytics.
- Optimized Project Delivery: Achieved a 25% increase in project completion rates, optimizing vendor coordination and stakeholder engagement strategies.
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
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
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