Wendy Pinson
Mc Kenzie,Tennessee
Summary
Nurse and clinical operations leader with over 17 years of experience managing complex clinical trials across various therapeutic areas and phases, from preclinical to Phase 4. Demonstrated success in driving multi-million-dollar initiatives and enhancing operational efficiency while building high-performing teams. Specialized in developing clinical and therapeutic strategies for sponsors, CROs, vendors, and sites, with extensive trial management experience in the US, LATAM, EU, and Japan. Recognized as a 2024 Top 50 Female Leaders of Tennessee for outstanding contributions to the field.
Overview
14
14
years of professional experience
Work History
Executive Director of Clinical Operations
Topogrphy Health, Inc
, CA
05.2024 - Current
- Lead a clinical operations team of 26 direct and indirect reports, including CRCs, CTAs, CTLs, regulatory, quality assurance, recruitment, and study start-up staff.
- Successfully hired and onboarded 85% of site staff since joining, strengthening team capabilities and operational consistency.
- Established efficient study start-up processes that accelerated site activation timelines by approximately 3 months, improving trial launch speed and reducing costs.
- Spearheaded multiple multi-million-dollar clinical trial projects, consistently meeting timelines and budget goals.
- Built foundational SOPs and DOPs for clinical operations in a previously policy-free environment, ensuring compliance and operational standardization.
- Developed a quality assurance framework with weekly QA reviews of study visits across all CRCs to maintain high data integrity and protocol adherence.
- Collaborated on the creation of a clinical operations career ladder, fostering professional growth and employee retention.
- Reported directly to the CEO and served as the head of all clinical operations, with full leadership responsibility over all employees within the department.
- Successfully led a FDA inspection with zero findings, as well as multiple sponsor and IRB audits, demonstrating regulatory compliance and operational excellence.
Vice President of Clinical Operations
Vial Health Technology, Inc.
San Francisco, CA
02.2024 - 05.2024
- Directed strategic planning efforts to advance pipeline development and position the company for sustainable long-term growth.
- Reported directly to the CEO and served as head of all clinical operations with full leadership responsibility over all clinical staff (26+ direct and indirect reports).
- Collaborated closely with business development teams to provide clear, concise clinical development support to 100+ sponsors across multiple therapeutic areas.
- Partnered with product team to provide clinical expertise in the design and implementation of the company’s in-house Electronic Data Capture (EDC) system.
- Trained and managed offshore business professionals, integrating global resources to support clinical operations.
- Managed medical staff, including medical directors and investigators, ensuring alignment with clinical strategy and trial execution.
- Led vendor management efforts across sponsors, recruitment, data entry, monitoring, and biostatistics vendors, optimizing partnerships.
- Successfully led multiple sponsor and IRB audits with zero findings.
Senior Director of Clinical Operations
Vial Health Technology, Inc.
San Francisco, CA
08.2022 - 02.2024
- Established key metrics for clinical protocol success aligned with organizational objectives.
- Scaled clinical operations team from 3 to 25+ employees including project managers, clinical leads, clinical research associates, and offshore resources.
- Developed and maintained an internal investigator database of 800+ US Principal Investigators, growing sponsor engagement significantly.
- Provided clinical expertise to CEO and cross-functional leadership, including AI-powered biotech product development.
Associate Director of Clinical Operations
Precision For Medicine
Norton, MA
02.2022 - 08.2022
- Aligned organizational resources with operational requirements, providing clinical strategy to 150+ sponsors.
- Led first COVID-19 clinical projects at the height of the pandemic, navigating unique challenges.
- Managed oncology-focused projects, contributing sought-after therapeutic expertise.
- Supervised data management, regulatory, project management, and study start-up teams.
- Implemented process improvements to boost efficiency across business development, clinical operations, and laboratory functions.
- Oversaw clinical operations budgeting to ensure cost-effective project delivery.
Manager of Clinical Operations
Precision For Medicine
Norton, MA
06.2021 - 08.2022
- Led regulatory, quality assurance, clinical monitoring, and project management teams, reporting directly to General Manager.
- Collaborated with vendors to secure critical clinical supplies during pandemic supply chain challenges.
- Directed opening and management of company-owned apheresis center and research sites, with multiple top-enrolling clinical trials.
- Managed review and preparation of clinical documents prior to IRB submission.
Clinical Project Specialist
Precision For Medicine
Norton, MA
11.2020 - 06.2021
- Built strong sponsor, site, and vendor relationships acting as liaison.
- Managed risk mitigation planning for 50+ preclinical projects.
- Worked closely with laboratory teams to fulfill sponsor requests.
- Rapidly promoted to clinical operations leadership role by General Manager.
Program Development Specialist
The Jackson Clinic
Jackson, PA
01.2019 - 11.2020
- Led clinical research program development for dermatology practice, transforming a research-naïve site into one of the top melanoma trial enrollers nationwide.
- Managed multiple programs simultaneously, collaborating across investigators, CRCs, senior leadership, and finance.
- Recognized repeatedly for enrollment and quality metrics excellence by sponsors.
- Recruited by Precision For Medicine to join their clinical operations team based on exceptional performance.
Clinical Research Coordinator
The Jackson Clinic
Jackson, PA
02.2012 - 01.2019
- Performed quality assurance on data entry into EDC, eTMF, and CTMS databases.
- Educated potential research participants and tracked adverse events and protocol deviations in collaboration with PIs.
- Managed up to 15+ simultaneous protocols across multiple therapeutic areas.
- Created and maintained all clinical trial documentation including regulatory documents.
- Successfully led multiple FDA inspections and sponsor/IRB audits with zero findings.
Education
Associate of Applied Science - Licensed Practical Nurse
Tennessee Technology Center
Jackson, TN09-2001
Skills
- Clinical Operations Leadership
- Multi-Therapeutic Area Expertise
- Protocol & Therapeutic Strategy Development
- Vendor & Site Network Management
- Team Building & Staff Development
- Regulatory Compliance & Quality Assurance
- Budget Management & Cost Optimization
- Cross-Functional Collaboration
- Clinical Trial Lifecycle Management
- Electronic Data Capture (EDC) Systems
- Global Clinical Trial Oversight (US, LATAM, EU, Japan)
- Process Improvement & SOP/DOP Development
References
Available upon request
Affiliations
- Top 50 Female Leaders in Tennessee (2024)
- Certified Clinical Research Professional
- Society of Clinical Research Association (SOCRA) Member
- GCP, BBP, HSP, & IATA Certified
Timeline
Executive Director of Clinical Operations
Topogrphy Health, Inc
05.2024 - Current
Vice President of Clinical Operations
Vial Health Technology, Inc.
02.2024 - 05.2024
Senior Director of Clinical Operations
Vial Health Technology, Inc.
08.2022 - 02.2024
Associate Director of Clinical Operations
Precision For Medicine
02.2022 - 08.2022
Manager of Clinical Operations
Precision For Medicine
06.2021 - 08.2022
Clinical Project Specialist
Precision For Medicine
11.2020 - 06.2021
Program Development Specialist
The Jackson Clinic
01.2019 - 11.2020
Clinical Research Coordinator
The Jackson Clinic
02.2012 - 01.2019
Associate of Applied Science - Licensed Practical Nurse
Tennessee Technology Center
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