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
29
29
years of professional experience
Work History
Consultant
Coastal Clinical Research Consulting, LLC
01.2025 - 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
01.2025 - 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