Charles D.

Preston
Pottstown, Pennsylvania 19465 (484) 354-1415 cpreston5876@gmail.com SUMMARY OF QUALIFICATIONS: Significant experience in product development from preclinical discovery to commercialization, including operational and project management, protocol development, regulatory review, and implementation of quality assurance and control programs. Sixteen years of infectious disease, oncology, and cardiovascular clinical experience including Phase I through Phase IV international trials, regulatory responses, and chairing investigator meetings. Proven direction of cross-functional clinical development, alliance and laboratory teams in addition to the development and oversight of innovative risk-based management, quality control and monitoring plans to ensure compliance with global regulatory requirements and standard operating procedures. Acknowledged leader in fostering effective working relationships with key investigators, opinion leaders, and industry representatives.

EMPLOYMENT: 11/2006-7/2011 ViroPharma Incorporated; Exton PA Director and Senior Director, Clinical Operations Responsibilities included, but were not limited to the following: Development and direction of global clinical operations teams and programs to execute product development goals, including leading all clinical operations aspects of pivotal multi-national Phase III clinical trials conducted in eleven (11) countries Development and presentation of department, therapeutic, quality and training objectives Initiation and facilitation of strong inter-departmental collaboration including regulatory and data quality strategies and support of global health authority activities and inspections Development, negotiation and management of a multi-million dollar departmental budgets Leading project teams to deliver objectives on time and to budget Evaluation, and management of CROs to ensure quality, cost-effective use, and the timely attainment of goals and compliance with regulatory requirements Providing monitoring, reviewing and tracking of clinical data and preparation of study specific documents. Authoring and contribution to the development of departmental standard operating procedures Reviewing, authoring and/or contribution to protocol, investigator brochure, and clinical development plan development Evaluation, critical review and constructive input to data validation plans, edit checks, specification documents and electronic database/case report forms. Providing senior management with necessary updates on progress and changes in scope, schedule and resources in a timely manner Organization, chairing and presentation at Investigator Meetings

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Oversee the development and growth of a proprietary clinical trial management system

2/2005-11/2006 Summit Drug Development Services; Rockville, MD Director, Clinical Operations Responsible for interfacing with internal and pharmaceutical company clinical and data management teams to evaluate their specific project goals and scope, develop and direct clinical operations teams, negotiate and manage contracts, and identify, develop and implement processes to facilitate and grow the business. 9/1997-2/2005 ViroPharma Incorporated; Exton, PA Clinical Research Manager and Director, Clinical Operations Responsibilities included, but were not limited to the following: Development and direction of U.S. based clinical operations teams and programs to execute product development goals, including leading all clinical operations aspects of two pivotal Phase III clinical trials (100 sites each) Development, negotiation and management of a multi-million dollar departmental budgets Evaluation, and management of CROs to ensure quality, cost-effective use, and the timely attainment of goals and compliance with regulatory requirements Providing monitoring, reviewing and tracking of clinical data and preparation of study specific documents. Authoring and contribution to the development of departmental standard operating procedures Reviewing, authoring and/or contribution to protocol and investigator brochure Evaluation, critical review and constructive input to data validation plans, edit checks, specification documents and electronic database/case report forms. Organization, chairing and presentation at Investigator Meetings

8/1995-9/1997 Sanofi Research, a Division of Sanofi Pharmaceuticals; Exton, PA Clinical Research Associate I and II Clinical project support including investigator site selection, site initiation, and routine monitoring and site closure clinical monitoring visits for phase II/III cardiovascular trials. Responsibilities also included: Assisting in the preparation of protocol amendments Drafting various internal regulatory decision making documents Responding to investigator, regional monitor or contractor queries regarding planned and ongoing clinical trials to ensure uniformity and consistency of study conduct Maintenance of close collaboration with project medical experts and other disciplines to coordinate timelines 6/1992-8/1995 Sterling Winthrop, Incorporated: Rensselaer, New York Senior Research Scientist Early phase method development and pharmacokinetic analysis for an anti-viral agent. Systems database and programming support for a world-wide VAX based application, including software design, validation, and training and regulatory compliance.

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1989-1992

Medical Center Hospital; Albany, NY Laboratory Manager Responsible for the oversight of a large clinical chemistry laboratory, including a staff of 42 FTEs, a multi-million dollar budget, adherence to regulatory guidelines, contract negotiations and nurturing strong professional relationships with medical staff. A.S., Laboratory Sciences / Mathematics Hudson Valley Community College Troy, New York B.S., Biology / Mathematics State University of New York at Albany Albany, New York Master Degree Course Work Union College Schenectady, New York

EDUCATION:

PROFESSIONAL DEVELOPMENT/OTHER: Member Drug Information Association Member Society of Clinical Research Associates External curriculum: o Project Team Leadership o Presentation Skills o Successful Negotiation o Effective Team Communication o Scientific Writing Skills o Biostatistics for Non-Statisticians o SQL*LIMS o RS/1 Overview Tables & Graphs o DOS 5.0 Awards: o Sterling Winthrop: Vision and Accomplishment Award for extraordinary contribution to the on-time implementation of a world-wide laboratory information management system (LIMS) o ViroPharma Incorporated: Accomplishment Award for exceptional operational leadership Community Service o Leader: Valley Kids Christs Church of the Valley Royersford, PA o Nursing Home Worship Leader