Senior Director, Operations
Senior Director, Operations
With more than 20 years of clinical development experience at both CROs and sponsor companies, Brett Gordon brings the individual focus a project requires while also providing a wider perspective of the clinical development landscape as a whole.
Working on both domestic and international trials of varying sizes and complexity, Mr. Gordon provides extensive knowledge of clinical operations, including initial development plan formulation, protocol writing, trial implementation, monitoring and delivery, clinical study report writing, and marketing applications.
Mr. Gordon has managed trials through the clinical development lifecycle from first-in-man, single-center Phase 1 trials to large 100+ center multinational Phase 3 trials. While he has worked across numerous therapeutic areas over his career, Mr. Gordon possesses in-depth CNS and pain expertise having managed or monitored trials in acute pain, chronic pain (neuropathic and musculoskeletal), epilepsy, bipolar disorder, major depressive disorder, generalized anxiety disorder, alcohol dependence, and ADHD.
ADHD has also been a focus for Mr. Gordon, as he has provided management or oversight of clinical trial programs for at least 5 compounds, helping sponsors bring to market stimulant products with novel delivery mechanisms or release profiles, as well as non-stimulant products for both pediatric and adult populations. Throughout his career, Mr. Gordon has developed and maintained strong relationships with key investigators and sites and is well versed in the complexities of analog laboratory classroom studies and controlled substance clinical supply management.
Similarly, Mr. Gordon has provided management or oversight for clinical trial programs for oral, topical, and most commonly, intra-articular injection products for osteoarthritis – including analgesics, NSAIDS, viscosupplements, and potentially disease-modifying small molecules and orthobiologics.
Very familiar with the unique challenges of pain studies, Mr. Gordon has worked with endpoint selection for pain and function (WOMAC, KOOS, NRS, VAS), including maximizing patient compliance with often daily pain/rescue medication diaries while minimizing placebo response.
Mr. Gordon graduated from Duke University in Durham, NC, where he obtained a BS in biology with a concentration in neuroscience.
Why clinical research?
“A lapsed pre-med, I discovered clinical research while taking a gap year following graduation from college but before applying to medical school. I had taken two pharmacology classes in college, both focusing to some degree on clinical development and trial design. Wanting to stay close to the medical profession during my year off from school, at the advice of one of my pharmacology professors, I applied for a job as a CRA at a small neuroscience-focused CRO and was soon traveling to sites, monitoring data, and learning clinical development with exposure to protocol writing, CRF design, data analysis, and CSR authoring. I found that through clinical research, I could actually satisfy much of what was initially driving me towards a career as a healthcare professional. And so, here we are, twenty-three years later, and my medical school applications remain pending.”
This is what drives Brett:
“I have always enjoyed puzzles and problem-solving. In high school, I was the kid who actually enjoyed geometric proofs and differential equations, as I loved the satisfaction of logically moving through a problem to derive an answer in as few steps as possible. And today, I’m still that kid with that same drive. Only now, it’s not checking my solution against the textbook answer key, but rather figuring out how our sponsors can most efficiently derive their answers. Whether those answers are used to support a regulatory filing and approval, or simply to get to the next stage of development for funding, acquisition, licensing, etc., these are the milestones which drive so many of our small to mid-sized clients.”