Robert G.

Wotring, MSBS
1021 Bryant Street, Palo Alto, California 94301
Phone: (650) 644-5377 / Email: rob_wotring@yahoo.com

INTRODUCTION

Clinical Program Director/Manager & Latin American Clinical Operations

Consultant/Liaison

• Expertise conducting clinical trials in Latin America based on 5 years of experience developing a
regionally-based clinical trials service organization while living in Costa Rica
• Broad knowledge of Latin American political & regulatory environment/agencies, cultural barriers,
• Existing relationships with Key Opinion Leaders/Investigators, Vendors
• Extensive rolodex of preferred regulatory affairs experts, project managers, and clinical monitors.
• Previous experience with recruiting, training, and managing MDs, PharmDs, PhDs, and RNs in
multiple Latin American countries
• Excellent written and verbal communication as well as negotiation skills
• Awarded an Honorary Doctorate in Nicaragua as a result of individual efforts to draft legislation
establishing guidelines for Research Involving Human Subjects
• Experience in working with clinicians in the private practice and hospital setting
CAREER SUMMARY
International Clinical Operations Consultant – Palo Alto, CA (July 2008 - current)
• International Project Management Regulatory Affairs, and Site Selection, and Monitoring in “1st in
Man” / “Proof of Concept” – Phase III Studies
o Protocol writing and feasibility assessment
o Study supplies importation & distribution management
o Site Monitoring & Management
o Regulatory affairs support
o Identification and selection of clinical sites
o Development and Negotiation of Clinical Trial Agreements/Budgets
o Processing Site Payments
o Evaluation and selection of clinical trials service vendors

Clinical Program Director - Latin American Clinical Research Sites – San Jose, Costa Rica -
(2004-2008)
Leadership/Operations
• Created a unique operational business platform used in successfully establishing 7 clinical research
centers of excellence in hospitals in Mexico, Costa Rica, and Brazil
• Recruited, trained, and led a team of 25 of highly educated, multinational clinical operations
professionals
• Developed, reviewed, and periodically revised study protocols, site monitoring plans, risk mitigation
strategies, RFPs, vendor contracts, trial budgets, SOPs, contingency plans, Study Protocols, and
Monitoring Reports

Corporate/Business Development
• Total sales in excess of USD$ 8M, at an Average Annual Growth Rate of 120%.
• Successfully negotiated more than 40 Clinical Trial Agreements/Site Budgets from 2004-2008
• Conducted primary market research, provided competitive intelligence utilized in financial analyses
(such as ROI / NPV) and forecasting
• Created the decision models utilized in corporate development and strategic planning
• Successfully negotiated Master Service Agreements with Major Pharmaceutical Companies,
including:
o Amgen
o Roche
o Eli Lilly
o AstraZeneca
o Novartis
o Allergan
• Negotiated service agreements with private hospitals in multiple Latin American countries that led
to the establishment of outsourced clinical research departments.
• Provided direct guidance in the establishing of ICH/GCP compliant Ethical/Scientific Review Boards
• Developed and presented program specific as well as annual corporate budgets and quarterly
project updates to Board of Directors and other private investment organizations

Director of Clinical Operations - CIMA Hospital Department of Clinical Research - Costa Rica -
(2004-2006)
• Interacted with supervisors of other departments with regards to staff allocation, forecasting
volume, and identifying department deficiencies with regards to clinical research
• Liaised with Ethics and Scientific Review Board, governmental agencies, and investigators on a
regular basis
• Developed and Implemented GCP/ICH compliant SOPs for various hospital departments as well as
SOPs and detailed operational guidelines for hospital affiliated Institutional Review Committees.
• Developed training materials and conducted professional development courses for hospital
personnel in ICH/GCP guidelines and national regulations
• Managed and negotiated individual study contracts and budgets on behalf of institution.
• Prepared Annual budgets as well as Quarterly and Annual reports for clinical research program
• Identified and evaluated clinical research studies as candidates for participation by the institution
Founder/General Manager - MD Physicians Research Network - North Carolina, (2001-2003)
• Developed a network of physicians who participated at various levels from, subject referral to
functioning as a principal investigator by making presentations at conferences and while meeting
with individual physicians and physicians groups
• Served as the primary contact for all study contract negotiations with sponsors and was responsible
for identifying potential studies and determining the ability to meet all sponsor requirements
• Developed and trained Site Managers, Clinical Research Coordinators, and Physician/Investigators
• Year 1 sales USD $220K
• Year 3 sales USD $850K
Specialty Sales Representative - Intermedics Orthopedics - Toledo, OH - (1993-1997)
• This was a highly consultative position with approximately 50% of time spent in the Operating
Room.
• Primary promotional product was Intermedics Orthopedics Total Joint Replacements
• Ancillary products included Arthroscopic and Endoscopic systems and disposables.
• Increased annual sales by an average of more than 200%over 3 year period, exceeding average
quota by 28%
• Final year sales were USD $1.15M
EDUCATION
Bachelors Degree in Psychology - Clemson University - Clemson, SC - (1984-1987)
Masters of Public Health in Epidemiology – University of South Carolina – Columbia, SC (1990-
1992)
• Didactic portion of program included advanced courses in Experimental Design, Biostatistics,
and Infectious Diseases
• Thesis topic (Predictive Risk Factors involved in the development of Fulminate Tuberculosis)
Masters of Science in Biomedical Research - Medical College of Ohio- Toledo, OH- (1998-2000)
• Clinical Research Emphasis
• Curriculum included the majority of Core Courses for 1st & 2nd Year Medical Students
AWARDS
Honorary Doctorate – Universidad Centroamericana de Ciencias Empresariales – Nicaragua
• “In recognition of extraordinary efforts to assist Nicaragua in developing internationally
compliant regulatory guidelines governing research on human subjects”
NCAA Division I All-American in both Cross-Country and Track & Field – 1985

References Available upon request