Washington, D.C. *****

***/***-****

e-mail:

add5lz@r.postjobfree.com

April J.L. Pradier

Education Bowie State University, Bowie, MD

§ Major: Biology

§ Bachelors of Science: May, 2001

Webster University, Washington, DC

§ Masters of Business Administration Program

Work Experience

3/12- present Chickasaw Nation (Contractor)

Hester Group (former Contractor)

U.S. Food and Drug Administration (FDA), Silver Spring, MD Office of Foods and Veterinary Medicine

Program Management and Mission Related Support

Services

Sr. Project Manager 10/12-present

Responsible for planning, developing, monitoring, implementing and collecting metric data as it pertains to high priority regulatory initiatives. Monitors the progress of all food safety research activities and captures minutes and action items for cross-cutting research coordination subgroups and subject matter experts to include microbiology, chemistry, nanotechnology and toxicology for CVM, CFSAN and ORA. Guides program and organizational development and supports Office of Foods Program Science and Research Steering Committee and the Chief Science Officer. Provides management and supervision of ORISE staff. Developed the SharePoint interface for the Science and Research and site structure. Supports the creation of presentations, briefings, reports, as well as printed, visual, and electronic media for the dissemination of findings and accomplishments that support FDA mission and research science goals. Manages the quality, timely delivery and the management of the Science and Research Team task as if relates to all research projects. Leads efforts in the evaluation of research impact and developed and leads an agency wide research impact working group. Serves as a liaison among stakeholders, in order to elicit, analyze, communicate and validate requirements or changes to business processes and policies. Provides strategy to business problems/opportunities and recommends solutions that deliver expected business value. Also implements and performs document management and supports IT staff, as needed. Works in close collaboration with analyst, directors, chairs, scientist and chief scientific officer as the functional counterpart in solution identification, coordination and management. Evaluates and tracks document information. Business Analyst 3/12-1/13

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Work Experience

(cont.)

Responsible for advising and standing up the Office of Food and Veterinary Medicine through the development of standard operating procedures, program integrity analysis, risk assessment analysis and change control management. Provides guidance and support in areas of strategic planning, information systems, resource planning and evaluation, risk-based priority setting and resource allocation, internal controls/continuous improvements and long-range facility planning for the Office. Develops and implements operational risk based strategic business management planning activities and the management of various initiatives for performance matrices, schedule, scope and budget. Engages FDA executive committees for approval of presentations, plans and reports. Manages risk and implementation of Food Safety Modernization Act (FSMA) program to communicate mandated food safety regulations for the prevention of food borne diseases. Identify and manage project risk with mitigation planning using Program Integrity Tools. Facilitate, implement and manage the review and analysis of reports and other various regulatory documents. Identify project issues with FDA collaborators and evaluates cross-functional decisions that enable objectives to be achieved.

12/09- 6/12 Ke’aki Technologies (Contractor)

US Army Medical Research and Medical Command

(USAMRMC), Washington DC

Telemedicine and Advanced Technology Research Center

(TATRC)

Tele-Medicine Project Officer/Associate Investigator, Clinical Trials

Responsible for medical devices human clinical trial planning, developing, monitoring, implementing and collecting metric data as it pertains to Tele-Traumatic Brain Injury (TBI), Acute Pain and Comprehensive Transition Plan Goals CT cell phone mobile care

(mCare) initiatives. Manages multi-site mCare activities at CONUS locations. Prepare and review clinical research documents, such as protocols and manuals, and serves as interface to the project manage and COR. Supports TATRC’s mCare research and development activities for human use research protocols. Managed contractor budget interactions. Also developed the SharePoint interface and site structure for the trials, which implements and performs document management and quality assurance. Serves as an Associate Investigator in evaluating mCare products in clinical trials. Supports the production of presentations, briefings, reports, as well as visual and electronic media for the dissemination of findings and accomplishments. Provides management and supervision to clinical and IT staff. 8/09-2/12 PharmAthene, Inc., Annapolis, MD

Program/ Senior Project Manager

Manages advance R&D Phase II and III human clinical trial project control, development and execution of an over 200 million dollar novel bio-defense second generation recombinant protective antigen anthrax vaccine program under the US Dept of Health and Human Services April J.L. Pradier

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through Biomedical Advanced Research and Development Authority that is targeted for future commercialization and procurement in the US Strategic National Stockpile. Reviews and supports essential documents such as R&D business and technical proposals. Leads an interdisciplinary team consisting of representatives from various functional divisions of the company including R&D, Regulatory Affairs, Clinical Development and Validation, Quality and Manufacturing to license the AIG product for use as a therapeutic agent for anthrax infection countermeasures. Creates, updates and revise project work plans (SOW), risk mitigation plans and work breakdown structures, as appropriate, to meet changing needs and requirements. Prepare press release and other communications. Develop and implement project management tools to facilitate the monitoring of technical scope and financial progress in support of the project team(s) and subcontracts. Also as a Share Point project manager administrator, implements and performs document management, and training for intranet/extranet sites. Monitor project progress with respect to contracts terms/milestones, WBS, budgets, and identify potential deviations and issues. Maintains and oversees risk management plan to recommend corrective actions/conformance to the plan. Evaluates and manages the program cost, budgets, forecast schedule, change management and performance using EVMS. Prepare and present project technical proposals, briefs, BAA White Papers and financial status reports for company’s senior management and customers. Prepare and review RFP/grant applications, regulatory submissions, study protocols and reports, provide research support as directed. Ensure project technical and financial documents are complete, current, and stored appropriately. Oversee manufacturing technology transfer and organizational migration. Manages and executes expense reports, procurement, subcontractor consent procurement packages, invoicing, purchase request and purchase orders. Facilitate program and executive meetings; prepare and finalize program agendas and minutes to ensure follow up and closure of action items. Prepare and present presentations.

4/08-7/09 Eurofins Medinet, Inc., Chantilly, VA

Project Manager, Global Clinical Trials 4/08-7/09

Directs the planning, implementation and manage organizational testing, in support of multiple large-scale global client clinical trial projects in all stages of development (Pre-clinical, Phase I – Phase IV and Surveillance). Manage client relations with pharmaceutical and biotech organizations to complete all aspects of the clinical trial. Consults clients in FDA and EMEA guidelines. Creates study specific documentation such as study synopsis, procedures, SOP’s, investigator laboratory manuals, investigator brochures, clinical protocols, forms and other materials as needed. Coordinates and liaise interdepartmentally and interact with data management, laboratory management, operations support and logistics department for the manufacture and distribution of inventory and materials. Prepares, creates and delivers status reports, project plans, budgeting and report monthly revenue recognition targets and milestones. Participate in the quality control checks for study April J.L. Pradier

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specific data. Delivers presentations to a wide variety of audiences including clinical investigators and clinical research organizations (CRO). Ensures transparent management of multiple global projects and assist with Business Development in strategic planning.

Manager, Antimicrobial Surveillance Department 8/08-7/09 Directs the planning and management of global anti infective surveillance studies and projects in support of all phases of anti-infective drug & vaccine development and commercialization. Performs bio- surveillance and disease management support. Consults with the client on microbial drug resistance and susceptibilities. Account for major milestones and deliverables in regards to global projects. Manages world’s largest repository of current characterized and clinically relevant bacterial pathogens. Also, contributes and participates in Bid-Defense meetings and contract negotiations meetings. Performs duties of data analysis to process, gather and transform data on behalf of the client, as requested. Also, attend and present presentations at global meeting. 8/01- 1/07 Clinical RM (Contractor)

Walter Reed Army Institute of Research, Silver Spring, MD Department of Enteric Infections

Division of Communicable Diseases and Immunology

Shigella Invaplex Characterization Suite

Research Microbiology/Immunology Technician

Perform duties in development, management and implementation of Shigella multivalent vaccines at Walter Reed Army Institute of Research in Pre-IND, Pre-clinical, Phase I, II & III clinical trial under 21 CFR and cGMP compliance. Assist in the planning, preparation for the submission of the IND and NDA. Executes quality control and assurance in support on clinical trial initiatives. Performs ELISA's, ASC's, cryogenisis, spot blot, BCA assays, organizes & conducts large-scale serological studies, writes and reviews SOP’s, maintains BHK, HeLa and Human CaCo2 cell line, tissue culture, cell culture, water extraction, immunization & collection of tissue from animals; collates, analyses and summarizes data using Excel, stat view, delta graph and soft max pro. Also conduct project budgeting, quality control and assurance (QC/QA) under FDA regulations for Invaplex Research Laboratory. Serves as liaison to international and domestic collaborators and vendors.

Professional

Training

12/12- present CITI

DoD

9/11- present Procurement Management Training

PharmAthene

9/11- present ITAR

PharmAthene

5/09-present GMP, GCP, GLP, GCLP, GDP and GxP Training Eurofins Medinet

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3/09-present Proposal Writing and Contract Management for Business Development

Foundation Center

10/05-1/08 Department of Defense (DoD) Transport of Biomedical Material: Offical of Biomedical Material Certified (WRAIR/USCHPPM) Walter Reed Army Institute

US Army Center for Health Promotion and Prevention Medicine 4/03-1/08 Good Laboratory Practices (GLP) Regulations: Introduction and Practical (WRAIR/USAMRIID)

Walter Reed Army Institute

8/01-1/08 Health Insurance Portability and Accountability Act

(HIPAA) Privacy Rule Policies Training

Walter Reed Army Institute

8/01-1/08 MSDFS Training, Hazcom, Fire Prevention, Bloodborne Pathogens, Animal Handling, Phenol Awareness Training and Transport of Biological Material, HIPAA

Walter Reed Army Institute

2/00-2/00 FDA2000: Cellular & Molecular Immunology The Foundation for Advanced Education in the Sciences, Inc. National Institutes of Health

Certificate Awarded

Special Skills/

Technology

Earned Value Management Systems, Cobra, Cognos, Cost Point, Share Point, Appian, IRBNet, Clinayxs, Master Control Change Control Systems, SAS, Invitro, Macintosh OSX, Windows, Microsoft Office Suite, Visio, Prezi, MS Project, Scientific Computing, LIMS management, DoD National Agency (BI) Security Clearance (Confidential Clearance) Reference Upon

Request

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