Brian D. Dean Email & Phone Number

Austin, Tx, Us

▪ Represent Clinical Operations and communicate with key stake holders.▪ Recruit, train and lead clinical operations team. ▪ Implement clinical performance indicators.▪ Manage clinical site and investigator identification, and study execution.▪ Manage relationship with CROs, experts and investigators.▪ Responsible for quality checks of clinical projects and compliance with SOPs, ICH-GCP.▪ Responsible for the operational sections of clinical documentation (e.g., protocols, investigator-brochures and clinical SOPs).▪ Support regulatory submissions and interactions with FDA, EMA, and other regulatory agencies.

Clinical Operations Consultant working multiple roles as a contractor for pharmaceutical companies.

Planning, implementation, and execution of Phase 1 and Pivotal clinical trials, including study deliverables, milestones, and data quality. • Early Phase Trials with rare disease indications, and healthy volunteer trials.• Leading multiple in-house and vendor clinical trial teams.• Supervision of CRO Selection and CRO daily management.

Melbourne, Vic, Au

Clinical Operations leader managing in-house clinical trial teams, clinical site investigators, CROs, and other relevant study vendors.• Development of clinical trial protocols, amendments, and other trial-related documents, plans, and processes.• Investigational Product was nonautologous mesenchymal stem cells tested for treatment of chronic lower back pain, graft versus host disease, and congestive heart failure.

Zug, Ch

Head of USA Clinical Operations department.• Supervised a global team of Clinical Trial Managers providing operational and technical expertise. Direct reports were located in USA and Nice, France.• Oversight of all USA Clinical Operations department budgets and standard operating procedures.• All clinical trial indications were dermatology focused.

Clinical trial operations consultant. Completed contracts in various roles within Clinical Operations for sponsor pharmaceutical companies. One contract required temporary relocation to San Francisco, CA.• Contracted as a Clinical Trial Manager and CRA for multiple Phase 1 and 2 clinical trials.• All trials were for oncology investigational products.

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Planned, executed, monitored, and reported clinical trial programs across multiple global geographic territories consisting of; United States, Oceania (Australia, New Zealand), and European Union.• Therapeutic indications for all trials were rare disease; Dupuytren's Disease, and Peyronie's Disease.• One product's Biologics License Application (BLA) and supplemental BLA each received FDA Approval.

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Managed and executed new product clinical trials according to protocol, applicable regulations, ICH-GCP, and SOPs. • Conducted oversight of Phase 2 and 3 rare disease clinical trial activities.• Supervised in-house clinical trial teams and CRO project teams.

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Managed clinical investigator sites, and CRO monitoring teams on Phase 3 trials.• Monitored compliance with the clinical trial protocol and all applicable regulatory requirements.

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Performed routine site visits including; Pre-Study, Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs). Visits included monitoring of informed consent procedures, compliance with study protocols, GCP/ICH guidelines, and other applicable regulatory requirements.

Performed routine site visits including; Pre-Study, SIV, IMV, and COV.

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A data management position responsible for Case Report Forms (CRF) review, issuing of data queries, and coding of adverse events (AEs) and concomitant medications.

A data management position responsible for CRF review, and issuing of data queries.

Master Of Science (M.S.), Clinical Research Organization And Management

Bachelor Of Science (B.S.), Biology