Lafayette Trawick

About Lafayette Trawick

With 30+ years in clinical research and development, I specialize in leading global trials, ensuring regulatory compliance, and optimizing clinical operations for pharmaceutical, biotech, CRO, and hospital organizations. As CEO of Regency Consulting Group since 1997, I’ve successfully guided strategic initiatives and provided clinical oversight for leading sponsors including Pfizer, Novartis, Merck, Bayer, Biogen, and Johnson & Johnson.I’m a Subject Matter Expert (SME) across Phase I–IV trials with a track record in project turnaround, CRO/vendor management, site oversight, and protocol strategy. My therapeutic breadth is wide and deep—encompassing everything from oncology to neurology to infectious diseases. Before launching Regency, I served as Director of Clinical Research at North General Hospital (NYC), where I developed cross-functional programs focused on advancing research equity and outcomes in underserved communities. Therapeutic Areas of ExpertiseOncology | Cardiovascular | CNS | Infectious Diseases | Respiratory | Neurology | Pain | Dermatology | Diabetes | Hepatitis/HIV | Urology | Sleep Medicine | Autoimmune & Inflammatory | Medical Devices | Rare Diseases I help research teams achieve strategic goals, milestones, key deliverables, stay on track, solve operational bottlenecks, and deliver results—on time and with integrity.

Experience

1. Global Clinical Operations Leader - Sr Manager

   Biogen

   Jan 2021 — Present · Raleigh-Durham-Chapel Hill, NC, US

   Partners with Medical Research and other functions to develop operationally feasible and clear protocol concepts and final protocols. Leverage Phase and operational expertise to establish study level operational strategy in alignment with the Clinical Development Plan (CDP) and program level strategy. Independently oversees one or more trials by establishing the operational strategy and securing excellence in execution through the CRO partner.KEY RESPONSIBILITIES:1) Partners with Medical Research and other functions to - Develop scientifically robust, operationally feasible and clear protocol concepts and protocols, and feasible protocols and robust data monitoring plans - Leverage appropriate on going data review to identify and mitigate patient, study design, data or study conduct issues - Ensure all operational aspects support end point integrity and data validity. Has a robust understanding of the study design including rationale, end points and patient population, and will ensure that the operational strategy supports both feasibility and scientific integrity. 2) Secures operational excellence and delivery for one or more clinical studies by- Developing operational strategy (including ancillary vendors) aligned with the program strategy and incorporating country input through the study Clinical Country Lead - Overseeing the tactical execution of the operational strategy by the partner CRO; Driving performance, quality, timelines and relationships through the CRO partnership model - Chairs the [Study Management Team] in partnership with the CRO study Lead of the [Study Management Team]; 3) Strives for effective, consistent, efficient and compliant processes by- Championing best practice development in Phase planning and seeks opportunities for innovation and efficiency with the Clinical Operation Management group -

Education

• Oakwood University

  Bachelor's degree, Biology and Chemistry

Skills

• Medical Affairs
• Biotechnology
• Medical Devices
• Clinical Research
• Edc
• Therapeutic Areas
• Ctms
• Pharmaceutics
• Inflammation
• Data Management
• Clinical Trials
• Infection
• Sop
• Central Nervous System
• Drug Safety
• Respiration
• Clinical Operations
• Drug Development
• Gcp
• Clinical Development
• Inform
• Infectious Diseases
• Neurology
• Medicine
• Oncology
• Urology
• Dermatology
• Informatics
• Protocol
• CRO
• Medical Imaging
• Diabetes