Education:

Fairleigh Dickinson University, Teaneck, New Jersey.

B.S. - Major, Biology; Minor, Chemistry.  June, 1967.

Experience:

April 2003 to Present

Provide consulting services to Pharmaceutical Industry in the areas of clinical operations (study conduct), investigator meetings and GCP/SOP training (live & Internet delivery).  

April 1998 to April 2003

Barnett International, Media, Pa 19063

Director, Business Development, Consulting & Clinical Training

Responsible for business development of training programs and related consulting services.  Assessment of client needs and  design of the strategy for development and delivery of creative training solutions to meet their educational goals both domestic and international. Clients include Pharmaceutical, Biotechnology, CROs, University Medical Centers and US Federal Government.  Responsible for client account management and development, preparing and maintaining client account plans,  tracking account expansion, oversight of project management, quality assurance and account staffing.  Represented Barnett International in academic and governmental interactions.  Represent Barnett International in Parexel corporate initiatives.                                               

June 1996 to April 1998

Hoechst Marion Roussel Inc. (AVENTIS), Bridgewater, NJ 

Director of Global Training, Global Clinical QA Department

Direct all technical training programs and activities within the Global Drug Development Center (Bridgewater, NJ), development sites Frankfurt, Germany; Tokyo, Japan; Kansas City, Mo.; Romainville, France) and subsidiaries worldwide.  Develop and oversee the implementation of a Global Training Strategy to meet the needs of the HMR organization. Coordinate the expansion of the existing international training organization by insuring the establishment of a training department in both Kansas City and Tokyo and a network of Training Correspondents across all subsidiaries conducting clinical studies.  Develop, maintain and coordinate the implementation of training plans on a global basis to ensure optimal use of resources.  Oversee the design, development, harmonization and implementation of training programs for all functions across development to provide the skills to promote consistency in processes.   Courses should include new clinical processes & systems, GCP, SOP, therapeutic, protocol specific training and soft skills training.  Design and perform training needs assessment in cooperation with the global functional heads and design appropriate programs to meet these needs.

June, 1992 to June 1996

Hoechst-Roussel Pharmaceuticals, Inc.

Manager, Technical Training and Continuous Improvement

Direct and supervise the design, development, implementation and assessment of technical training programs for all employees.  Hire, develop, supervise and direct the activities of the Technical Trainers and Training Administrators within the Department to promote a working environment that fosters teamwork and communications, as well as exemplifies the Quality Values.  Lead the development of training programs to be utilized worldwide.  Support of Strategic Initiatives:  Member of Steering Committee for development and revision of Standard Operating Procedures (SOP) for GCP and FDA compliance; Conduct audits for certification of Contract Research Organizations (CRO preferred suppliers); OP model - process redesign and change implementation, functioned as Global Project Leader leading a multi-national team consisting of 14 individuals during the re-engineering of clinical research and development processes.  The primary goal of this effort was to reduce the development and regulatory approval time for new pharmaceutical products by 30%.  This global team re-designed the clinical research and development process, standardized these processes to accommodate all countries and subsidiaries, identified the roles required, and selected/tested the software to support this design. 

November, 1988 to June, 1992

Hoechst-Roussel Pharmaceuticals, Inc.

Clinical Research Manager, Phase IV Operations

Departmental oversight of project planning, design, implementation and evaluation of clinical programs for various marketed therapeutic agents; coordination and supervision of field activities of clinical research associates; strategic planning in conjunction with sales and marketing departments for short and long term projects to support promotional programs; pre-product launch clinical trials; and budget planning; generation of scientific publications and supplemental NDAs as well as other required reports for submission to regulatory agencies; SOP development;  technical training; clinical advisor/liaison between sales/marketing Drug Regulatory Affairs, and Medical departments.

October, 1976 to November, 1988

Hoechst-Roussel Pharmaceuticals, Inc.

Senior Clinical Research Associate, Medical Research Department

Clinical research position involving the planning, preparation and design of protocols and case record forms for Phases I, II, III, and IV studies of various therapeutic agents such as psychotropic, antihypertensive, antimicrobial, antineoplastic and antidiabetic agents; Phase II, III trials of implantable devices; investigator interviews and financial negotiations; initiating and monitoring of clinical trials; collecting and summarizing of statistical data; preparing IND and NDA submissions as well as other reports for submission to regulatory agencies; serving as consultant to Marketing Department; coordinating activities of various ancillary departments; training and supervising new personnel; coordinating investigator meetings and training seminars; preparation of technical press releases.

March, 1974 to October, 1976

Hoechst-Roussel Pharmaceuticals, Inc.

Clinical Research Associate, Medical Research Department.

Duties as above with less emphasis on the administrative aspects of clinical trials.

November, 1973 to March, 1974

Warner Lambert Company (Pfizer)

Research Scientist
Consumer Products Division

Clinical Research position involving the design of protocols and case record forms for Phase IV consumer products such as cough/cold, analgesic and antacids; initiating and monitoring clinical studies in support of advertising claims, labeling changes and bioequivalency.  Preparation of clinical study reports; serving as marketing clinical consultant, reviewing and approving promotional materials.

December, 1972 to November, 1973

Sandoz-Wander, Inc. (Novartis), Hanover, NJ

Senior Research Associate
Clinical Research Department

Supervisory position involving the development and writing of protocols and design of case record forms for Phase I, II, III, and IV drug studies relating to antihistamines, tranquilizers, and cardiac glycosides; CRA training and coordination; initial interviewing of potential investigators; monitoring of clinical studies, followed by the collection and summarization of statistical data; preparation of final study reports; coordinating investigator meetings and training seminars. 

March, 1972 to December, 1972

Sandoz-Wander, Inc.

Clinical Research Associate
Clinical Research Department

Duties as above in a non-supervisory capacity.

September, 1968 to March, 1972

Sandoz-Wander, Inc.

Research Assistant
Pharmacology Department

Pre-clinical position involving the biological testing of new compounds primarily in the analgesic, anti-inflammatory, and respiratory areas; applied research; methods development; report writing; directing work output; training and supervision of new employees.

July, 1967 to September, 1968

Sandoz-Wander, Inc.

Analytical Chemist
Analytical Services Department

Analytical methods development; evaluation of crude drugs and dosage forms; stability testing; technical representative.