Brett Gordon

About Brett Gordon

25+ Years Clinical Development Experience • 20 Years Project Management Experience -Domestic – Phase I through IV (Drug/Biologic)+ Class (Medical Device)-International – Phase I and Phase (Drug/Biologic)+ Medical Device• 4 Years Clinical Monitoring Experience (Phase I-IV)• 8 Years Operations/Line Management Experience• Regulatory Submission/Scientific Document Preparation Experience -Domestic - IND, IDE, ISS/ISE, Annual Reports, Protocols, Clinical Study Reports, Safety Narratives -International - CTA, IMPD• SOP Development• Quality Assurance AuditsTherapeutic Areas:• CNS (ADHD, Alcohol Dependence, Bipolar Disorder, Epilepsy, Parkinson’s Disease, Neuropathic Pain, Major Depressive Disorder, Generalized Anxiety Disorder, Schizophrenia, Chronic Pain, Acute Pain, Spinal Cord Injury, Idiopathic Hypersomnia)• Cardiovascular (Hypertension, PAOD)• Endocrinology (Diabetes- Types 1 and 2)• Inflammatory Disease (Rheumatoid Arthritis)• Pulmonary/Respiratory (Cystic Fibrosis, COPD)• Gastrointestinal (Gastroparesis)• Ophthalmology (Diabetic Macular Edema, Neovascular Age-Related Macular Degeneration)• Orthopedics (Degenerative Disc Disease/Lumbar Fusion, Tibia Fracture, Osteoarthritis)• Otolaryngology (Hearing Loss)• Oncology (Chronic Myelogenous Leukemia)• Rare Disease (Aspartylglucosaminuria, CLN5, CLN7, Charcot-Marie-Tooth)

Experience

1. Vice President, Project Delivery

   Rho

   Sep 2025 — Present · Durham, NC, US

   Leads the strategic and operational direction of the Project Delivery function across therapeutic areas, with a focus on standardization, collaboration, and client success• Oversee a high-performing Project Delivery team, ensuring consistent execution, quality delivery, and alignment with organizational goals• Sets and executes the strategic vision for Project Delivery, aligning operational capabilities with business growth objectives• Leads cross-functional teams to deliver high-quality, on-time, and on-budget clinical programs across diverse therapeutic areas• Drives account expansion by identifying opportunities to deepen client partnerships and broaden service offerings• Partners with Business Development and senior leadership to shape proposal strategy, client engagement, and portfolio growth• Serves as executive sponsor for key client relationships, mitigating risks and ensuring long-term partnership success• Develops and implements scalable staffing strategies that support growth, client satisfaction, and team development• Champions a culture of collaboration, consistency, and innovation across project teams• Drives continuous improvement through the development and refinement of best practices in project management and clinical operations• Monitors industry trends and regulatory changes to inform strategic planning and ensure competitive positioning

Education

• The Bullis School

  HS Diploma, Advanced Placement/High Honors Curriculum

  1988 — 1992

• Duke University

  BS, Biology

  1992 — 1996

Skills

• Budgets
• Class Iii Medical Devices
• Ich-Gcp
• Clinical Operations
• Clinical Data Management
• Regulatory Affairs
• Biotechnology
• Drug Development
• Pharmaceutical Industry
• Sop
• Gcp
• Fda
• Clinical Trials
• Clinical Study Design
• Timeline Development
• U.s. Food and Drug Administration (Fda)
• Standard Operating Procedure (Sop)
• Project Management
• CRO
• CRO Management
• Ind
• Medical Devices
• Clinical Research
• Protocol
• Clinical Development
• Cns Disorders
• Regulatory Submissions
• Preparation of Proposals
• Medical Writing
• Edc
• Therapeutic Areas
• Ctms
• Good Clinical Practice (Gcp)
• Phase I
• Clinical Monitoring
• Clinical Trial Management System (Ctms)
• Vendor Management
• Neuropathic Pain
• Presenting Proposals