Brent Dayton
Manager NonClinical Development @ PTC Therapeutics, Inc.
About
Focused, Driven, Positive, Passionate
United States
Portage
Biotechnology
Business Strategy, Clinical Development, Workable Solutions, Strategic Planning, Proactive Leadership, Project Status Reporting, Pharmaceutical process development, Regulatory Affairs, Implementation Plans, Regulatory Submissions, Contract Management, Data Management, Delineation, Performance Motivation, Budgeting, Communication, Study Monitoring, Team Building, Strategic Communications, - Pre-Clinical Reporting/Data Review - Contract Management - C-Level Relation
Experience

Manager, Report Services (General Toxicology & Infusion)
Mattawan, Michigan
Responsible for implementation of new procedures and refinement of existing procedures to promote increased efficiency and quality Departmental planning, including budgeting and resource management. Supervisory responsibilities in accordance with organizational policies and applicable laws to include interviewing, hiring, and training employees; planning, assisting, and directing work; appraising performance and completing performance reviews; rewarding and disciplining employees; addressing complaints and resolving problems. Adherence to safety procedures at all times.

Study Coordinator (General Toxicology & Infusion)
Mattawan, Michigan
Developed study protocols, animal care and use protocols (ACUPs); authored protocol amendments, and directed laboratory personnel via Departmental Notifications in close conjunction with the Study Director. Provided administrative backup support for day-to-day study specific activities. Participated in pre-initiation and other study-related meetings. Accompanied Sponsors to study rooms and provided updates on animal health or study trends. Reviewed on-going study data and reported any potential trends or effects. Worked closely with the Veterinary Staff, Study Directors, and the Institutional Animal Care and Use Committee (IACUC) as for requested revisions to ACUPs and/or protocols. Proficient in specific software used for proposal writing (Big Machines/Salesforce), Proactively responded to Quality Assurance Observations (QAAD), and ExyLims (Test Material Control/Characterization). Responsible for study number assignment authorization for Sponsor approved studies and study price adjustments. Provided support in designing proposals and proposal packages. Assisted in monitoring critical phases of assigned studies and reported any issues. Compiled data needed by the Study Director for Sponsor updates. Represented MPI Research as Principal Investigator for contracted work not requiring a Study Director (histopathology and/or clinical pathology work contracted to MPI Research for studies conducted elsewhere), or a Study Monitor for genetic toxicology studies subcontracted to other laboratories by MPI Research

Report Professional
Mattawan, Michigan
Contract Research Organization; pre-clinical drug development/discovery) Drug Safety Evaluation –Report Professional Evaluated study data, authored report summary, detailed results, and study conclusion; assigned noobserved-adverse-effect-level (NOAEL)/maximum tolerated dose (MTD) in consultation with Study Director and other scientific personnel. Strict adherence to U.S. FDA GLP CFR 21 Part 58 regulations, the Organization for Economic Development (OECD) regulations, study protocol requirements/creation, and MPI Research Standard Operating Procedures (SOP) pertaining to protocol authoring, reporting, data entry, and data review/presentation, and retention standards. Dependent in performing a detailed review of in-life, clinical pathology, gross pathology, and histopathology data and procedures related to general toxicology, target animal safety (CVM), pharmacokinetic, analytical formulations, and safety pharmacology studies. Responsible for various aspects of study reporting, including in-life and dose formulation analyses data table creation. Consulted with sponsors, study directors, laboratory personnel, and Quality Assurance Unit auditors to foster a streamlined reporting process for each study report. Constantly exceeded expectations related to quality and timely reporting. Managed efficient pre-report meetings ensuring a seamless reporting process. Conducted effective peer reviews on fellow coordinator reports and recommended areas of improvement to meet FDA GLP requirements, MPI Research reporting standards, and/or sponsor expectations.

Business Owner, Operator, and LLC Manager
B Douglas, LLC; d.b.a. The Original Smokers’ Haven
Columbus, Ohio Area
[Retail Tobacconist - Pipes, Premium Cigars, Tobaccos, and Accessories (non-cigarette)]; Identified in the Central Ohio community as an expert in the premium cigar, pipe, and pipe tobacco market. Personally selected inventory, obtaining best quality, value-driven products for customer base. Developed and implemented business plan to counter internet-based competition. Responsible for all aspects of business operations including payroll, accounts payable/receivable, collections, mail order operations, and government-related issues. Consulted with manufacturers on custom-made products, new product launches, industry trends, and customer requests. Designed, managed, and completed a $20,000 retrofit/capital improvement project for existing walk-in cigar humidor.

Account Executive
Enron
Columbus, Ohio Area
Provider of HVAC service plans, energy efficiency solutions, and design/build retrofit projects for commercial, industrial, governmental, and institutional facilities; Generated new business through relationship development, cold calling/prospecting, and referrals. Presented and proposed solutions to high-ranking officers of companies and institutions. Co-authored plans of action with customers/prospects to solve service and energy challenges. Developed and implemented effective marketing plans. Identified product preventive maintenance requirements and/or system defects. Analyzed operating budgets and identified areas of probable cost reduction for customers/prospects. Actively participated in Total Quality Management (TQM) Teams and various in-house projects (Accounts Receivable, Customer Communications, and Quality Measurement).
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