Ron Rowbotham Email & Phone Number

Kirkland, Wa

Design and manage clinical studies to support development and FDA Premarket Approval for Class III medical devices

Redmond, Wa

Design and manage clinical research studies for emergency medical devices

Greater Seattle Area

Managed a $42 million dollar multinational 2-year phase 2b/3 clinical study for a first-in-class oral medication to treat dry age-related macular degeneration with 440 subjects at 56 sites in the US and EU. A Phase 2b/3 Multicenter, Randomized, Double-Masked, Dose-Ranging Study Comparing the Efficacy and Safety of Emixustat Hydrochloride (ACU-4429) With Placebo for the Treatment of Geographic Atrophy Associated With Dry Age-Related Macular Degeneration.• Monitored subject enrollment and site activities. Achieved 75% enrollment milestone 6 months ahead of schedule. Maintained site costs within budget.• Managed IRB submissions• Established SOPs for site feasibility evaluation, selection, and initiation• Established 12 study management plans including site monitoring• Selected and negotiated scope of work for 11 Vendors including CRO, central labs, image reading center, ECG devices and central reading center, visual acuity (VA) devices and certification, electronic data capture (EDC), and IWRS.• Approved investigational product qualification and packaging/labeling/distribution• Developed forms and instructions for sites• Designed EDC case report forms • Negotiated and tracked site budgets and contracts• Planned and conducted Investigator Meetings in the U.S. and Germany• Managed clinical study team (4 CRAs, data manager, statistician, CMC associate, QA associate, safety manager, regulatory associate (FDA and EU), accountant, contract associate, project manager)• Developed and implemented departmental tools and standard operating procedures

Greater Seattle Area

Clinical Trial Manager and Lead CRAFor multiple drug development studies and multiple device/outcome measure studies,• Co-wrote protocols, established and negotiated budgets and contracts between Sponsors and our CRO and between our CRO and contract laboratories and sites• Managed all aspects of studies from startup through closeout, including preparation of all study materials including case report forms, and setup/management of trial master files• Managed the design and implementation of randomization schemes, manufacture, and packaging/labeling/distribution of blinded study drug• Developed and implemented clinical management and monitoring plans• Evaluated and initiated study sites, monitored site data and regulatory documents and adverse event reporting/follow-up, and managed contract Data Management Organizations• Led internal team to organize and implement electronic Study Master Files using LiveLink Document Control System, wrote and managed RFPs for data management services specific for 21 CFR part 11 compliant Electronic Data Capture systems/services• Authored and revised Standard Operating ProceduresStudies: A Long-Term Prospective Observational Safety Study of the Incidence of and Risk Factors for Fibrosing Colonopathy in US Patients with Cystic Fibrosis Treated with Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors. (135 site, Phase IV FDA-mandated post marketing study). Infant Study of Inhaled Saline in Cystic Fibrosis (30 Site, Phase II, Double Blind, Randomized Controlled trial)A two year study to assess the natural history of progressive CF lung disease utilizing controlled volumetric lung CT imaging, pulmonary function measurements, and clinical scores in children with mild CF lung disease (3 site, disease progression and outcome measure validation study).

Greater Seattle Area

Responsibilities and Accomplishments: • Designed and managed 24 clinical research studies from protocol development through closeout and publication (see Publications) in the fields of breast and prostate cancer, radiology, urology, and laparoscopic surgical technique.• Prepared grant budgets, managed tasks and timelines, prepared all study materials, monitored data, site performance and regulatory documents• Designed and administrated clinical databases• Performed statistical analyses• Prepared manuscripts and managed publication submissions• Implemented Continuous Quality Improvement and Statistical Process Control (SPC) methodology and taught SPC to hospital management personnel• Modeled processes using stochastic modeling software (MedModel) to optimize Hospital Emergency Unit redesign

Greater Seattle Area

• Managed multi-disciplinary teams in developing Class II respiratory metabolic measurement devices• Designed and tested analog electronics and software for PC-based respiratory exercise monitors and multiple software and hardware upgrades during the production phases of these devices• Directed quality control during design and manufacture of these devices• Authored design specifications, manufacturing procedures, product development procedures, device application notes for marketing/sales, test plans, and quality assurance procedures• Designed and managed clinical trials in support of FDA 510K device clearance applications• Provided on-site training, phone support and direct support to sales and marketing staff for trade shows and sales presentations

Spokane, Washington Area

• Performed resting 12-lead electrocardiograms on adult, pediatric, and neonatal patients in an 800-bed regional medical center• Performed cardiac exercise tests on adult patients• Performed CPR as a member of a cardiac code team

Master Of Science (Ms), Electrical And Electronics Engineering, Summa Cum Laude

Activities and Societies: Graduate Research Fellowship for Novametrics Inc. Seattle WADeveloped modeling Algorithms for solid state.

Bachelor Of Science (Bs), Biochemistry, Biophysics And Molecular Biology, Summa Cum Laude

Activities and Societies: Volleyball ClubMajor in Biochemistry/Biophysics. Completed a senior research project under Dr. James Magnuson.