Wendy Talbott
Clinical Development/Operations
Stonington,CT
Summary
Strategic vaccine development/operations leader with 25+ years of experience leading global, cross-functional programs from late development through licensure. Proven track record delivering large-scale Phase I–IV vaccine trials, translating Target Product/Vaccine Profiles into integrated development strategies, and driving execution across R&D, Regulatory, CMC, QA, and Commercial functions. Trusted advisor to senior leadership and governance committees, recognized for clear decision-making, proactive risk management, and the ability to align diverse stakeholders to accelerate development and advance global public health.
Overview
28
28
years of professional experience
4
4
years of post-secondary education
Work History
President
Coastal Clinical Research Consulting
01.2025 - Current
- Advise biotech clients on clinical strategy, program closure, vendor governance, and regulatory submission readiness.
- Delivered compliant closeout of 5 global programs, improving client satisfaction by 35% and reducing operational risk.
- Streamlined deliverables and cross-functional workflows, reducing project delays by 15%.
Vice President, Head of Clinical Operations
HilleVax
10.2021 - 12.2024
- Scaled and led a global Clinical Operations organization, improving operational efficiency by 45%.
- Owned multi-million-dollar budgets and forecasting, reducing operating costs by 20%.
- Established CRO oversight frameworks and compliance processes, improving compliance rates by 55%.
- Partnered with Clinical Development, CMC/Supply, QA, and Medical Affairs to ensure program alignment and inspection readiness.
- Oversaw development of protocols, ICFs, operational plans, and TMF documentation.
Senior Director, Clinical Operations
Novavax
07.2020 - 10.2021
- Built infrastructure enabling rapid scale-up from 3,000 to 15,000 subjects under accelerated timelines.
- Led end-to-end CRO oversight, ensuring on-time delivery and compliance across global labs.
- Developed coaching programs improving team performance and operational efficiency by 20%.
- Directed evolution of data collection processes for COVID-19 studies.
Director, Head of Operational Oversight
Takeda, Vaccines Business Unit
06.2018 - 07.2020
- Designed global operating frameworks, SOPs, and work instructions post-merger with Shire, improving consistency by 75%.
- Led field-based teams across three continents supporting four concurrent programs.
- Built CRO governance and performance-management models.
- Directed financial planning and resource allocation, improving efficiency by 45%.
Associate Director, Project Management
PPD (Thermo Fisher)
02.2015 - 06.2018
- Enhanced global lab service and delivery by adding specialty labs as preferred vendors. This infrastructure change reduced the sponsor's costs by 50% and increased operational efficiency by 75%.
- Collaborated with VP and Director level(s) to launch a focused vaccine services business unit, improving vaccine clinical trials 50%.
Manager, CIA Annual Planning
GSK Biologicals
06.2013 - 02.2015
- Provided oversight of 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.
Senior Global Study Leader
GSK Biologicals
06.2007 - 06.2013
- Served as the primary operational contact for all country sites involved in two significant 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
GSK Biologicals
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, which 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.
Senior Clinical Research Associate
PPD (Pharmaco)
01.1993 - 06.1996
Toxicology Analyst
PPD (Pharmaco)
11.1991 - 01.1993
Coordinator (Psychiatric Unit)
Mount Sinai Medical Center
11.1990 - 11.1991
Education
Bachelor of Science - Psychology
Frostburg State University
Frostburg, MD 09.1986 - 06.1990
Skills
Strategic planning
Operational excellence
Crisis management
Process improvement
Strategic visioning
Operations oversight
Partnership development
Change management
Financial leadership
Program management
Remote team management
Decision-making
Leadership and people development
Scope management
Teamwork and collaboration
Problem-solving
Organizational skills
Strategic thinking
Adaptability and flexibility
Verbal and written communication
Complex Problem-solving
Documentation and reporting
Risk management
Workflow Analysis
Timeline
President
Coastal Clinical Research Consulting
01.2025 - Current
Vice President, Head of Clinical Operations
HilleVax
10.2021 - 12.2024
Senior Director, Clinical Operations
Novavax
07.2020 - 10.2021
Director, Head of Operational Oversight
Takeda, Vaccines Business Unit
06.2018 - 07.2020
Associate Director, Project Management
PPD (Thermo Fisher)
02.2015 - 06.2018
Manager, CIA Annual Planning
GSK Biologicals
06.2013 - 02.2015
Senior Global Study Leader
GSK Biologicals
06.2007 - 06.2013
Operational Program Manager - Flu Franchise Lead
GSK Biologicals
08.2001 - 06.2007
Medical Program Coordinator
Aventis Pasteur, Inc.
06.1996 - 08.2001
Senior Clinical Research Associate
PPD (Pharmaco)
01.1993 - 06.1996
Toxicology Analyst
PPD (Pharmaco)
11.1991 - 01.1993
Coordinator (Psychiatric Unit)
Mount Sinai Medical Center
11.1990 - 11.1991
Bachelor of Science - Psychology
Frostburg State University
09.1986 - 06.1990