Robert E. Parson Resume

1. 4523 Cather Avenue ROBERT E. PARSON 858.357.6491
San Diego, CA 92122 robert.e.parson@gmail.com
EXECUTIVE LEADERSHIP
A dedicated leader with a proven track record of guiding products from concept to commercialization.
Experienced in developing and manufacturing products, ensuring quality and reliability. Played integral roles by
holding key membership positions on corporate FDA and global regulatory submission teams, enabling clearance
of hundreds of medical and IVD devices. Though leadership and decisiveness, implemented successful disease
management programs. Adept at use of finance and actuarial techniques combined with excellent communication,
team building, international business and program management skills.
CORE COMPETENCIES
Strategic Planning ♦ Consulting ♦ Project Leadership ♦ Program Management
Regulatory Affairs ♦ Pharmaco-economics ♦ Biometrics ♦ Process Engineering
International Business ♦ Quality Control ♦ Process Improvement ♦ Risk Management
Clinical Research ♦ Change Management ♦ Health Care Advocacy ♦ Disease Care Management
EDUCATION
UNIVERSITY OF CALIFORNIA, San Diego, CA
Masters of Advanced Studies: Leadership of Healthcare Organizations
Independent Study Project: A Comprehensive Review of Diabetes Chronic Disease Management Programs for the
Purpose of Identifying Features to Improving Outcomes, Reducing Cost and Maintaining Quality
Internships: San Diego Hospice Center and Scripps Whittier Diabetes Program
ROCHESTER INSTITUTE OF TECHNOLOGY, Rochester, NY
Masters of Science: Applied Statistics (Biostatistics)
Thesis Topic: Evaluation of the Monroe County Healthcare Library Network Statistical Education and Information
Systems Planning
PURDUE UNIVERSITY, West Lafayette, IN
Bachelors of Science: Biochemistry
Minor: Mathematics/Statistics
HIGHLIGHTS OF SKILLS & ACCOMPLISHMENTS
Pharmaco-economics & Outcomes Research
 Developed Markov Models for prostate cancer screening programs using Tandem tPSA and fPSA/tPSA
Ratio in support of Managed Care decision-making to provide tests in patient care protocols.
 Authored cost-effectiveness/budget impact models and analyses for immunological fecal occult blood tests
used in support of international, national healthcare system reimbursement and funding decision-making.
 Coordinated and direction to a global staff of 30 marketing and sales professionals preparing national and
regional healthcare system tender offers that incorporated budget impact analyses and comparative
performance analysis with technology assessment assessments.
Regulatory Affairs
 Directed and partnered across R&D, Clincal, Marketing, Business Development and Sales groups the
integration of required regulatory guidance into product regulatory approval and registration strategy.
 Enabled global cost analysis and reporting by implementing a budgeting/cost tracking system that
resulted in improvements in tracking expenditures for international registration and labeling changes.
 Facilitated introduction new product and product improvements by managing all aspects of approval

2. process for large, diverse global organization.
ROBERT E. PARSON - PAGE 2 OF 4
858.357.6491 - robert.e.parson@gmail.com
Clinical Operations
 Established Global Clinical Affairs organization for Inverness Medical Innovations to support clinical
programs. Transformed group of small, disjointed staffs with varying levels of education and experience
into efficient global network.
 Integrated Electronic Data Capture (EDC) with Clinical Study Information procedures and Clinical
Information Management System (CIMS).
 Successfully initiated international clinical study / trial programs for post-registration studies that allowed
regional organizations access to clinical and EDC resources via Centers of Clinical Excellence.
Biostatistics
 Evaluated new medical diagnostic assays for FDA and global approvals, clinical trial protocols, statistical
plans, and detailed submissions for regulatory clearance.
 Oversaw completion of 300+ 510K and 4 PMA FDA submissions and supplements, plus corresponding EU,
Japanese, and Australian submissions.
 Presented PSA (prostate specific antigen) screening claim to FDA PMA panel meeting. Wrote SAP and
supported 6,770 patient studies with statistical analysis. Wrote CSR for study.
 Evaluated clinical designs for efficacy, statistical power, and assumption verification and identify strengths
and weaknesses of clinical study using simulation methods. Designed SAP for Tandem tPSA, fPSA, CA125,
CA19.9, Ostase, AccuTnI Troponin assay, and many others (Hemoccult Sensa, ICT, NS-Plus, Blood
Chemistries).
Clinical Data Management
 Performed strategic systems planning combining electronic data capture (EDC) and clinical trial
management system (CTMS) along with document management, registration dBase, on-line training
systems, electronic medical device reporting (eMDR), and SharePoint systems implementation for
international project management.
 Devised and implemented organizational, procedural, and processing changes to achieve regulatory
compliance.
PROFESSIONAL EXPERIENCE
ALERE INC. (formerly Inverness Medical Innovations), San Diego, CA
Alere is comprised of 18 leading diagnostic and health management companies and is the second-largest health management
provider in United States producing revenue of $2.1 billion. Employees span the globe.
Vice President, Pharmacoeconomics & Outcomes Research 2010-2011
Managed generation of $50 million in revenue from oncology products (NMP22 (BladderChek, NS-Plus iFOBT
joint distribution between Otsuka Electronics Corporation and Alfresa Pharmaceutical Corporation). Drove
progress of new products and oversaw international tenders program, regulatory clinical studies in US, China, and
Canada, and regulatory submissions.
• Collaborated with leaders in global organization to devise strategy to obtain funding to implement new
technology in countries with National Healthcare Systems.
• Created strategy for global distribution of the NS-Plus i-FOBT assay system, obtaining agreement of all 3
distribution partners (Alere, Alfresa, and Otsuka).
• Incorporated efficiency and cost effectiveness simulation models to compare costs in connection with
staffing resources, laboratory space, reagent costs, laboratory data, and information processing into
marketing and sales of new technology.

3. • Planned and prepared for efficient integration of outcomes studies into analysis of laboratory technology
under evaluation of international healthcare organizations.

4. ROBERT E. PARSON - PAGE 3 OF 4
858.357.6491 - robert.e.parson@gmail.com
INVERNESS MEDICAL INNOVATIONS (formerly Biosite and now Alere, Inc.), San Diego, CA
International medical device manufacturer with product portfolio spanning cardiovascular, drugs of abuse, women's health,
oncology, and infectious disease areas. Led market in rapid point-of-care diagnostic and clinical testing. With 11,900
employees worldwide, produced $2.1 billion in revenue.
Vice President, Global Clinical & Regulatory Affairs 2008-2010
Directed global clinical and regulatory affairs for 55 companies and distributors for 1,600 products enabling
detection and management of autoimmune diseases, infectious and enteric diseases, sexually-transmitted diseases,
colorectal and bladder cancers, and cardiac risk. Supervised team of 15 senior-level managers and oversaw global
clinical staff of 225. Managed annual budget of $24 million.
• Established Global Clinical Affairs organization to support company’s clinical programs, which was
comprised of 75 employees worldwide.
• Standardized training programs and training schedules for all staff, transforming previously disorganized
programs into unified and efficient programs.
• Provided regional organizations with access to clinical and EDC resources by using Centers of Clinical
Excellence.
• Streamlined processes for effective and timely medical devise reporting, improving turnaround from 12
weeks to 4 weeks.
• Formed Medical Affairs Team to handle off-label customer requests.
• Instituted additional regulatory guidance into product regulatory approval and registration strategy,
working in conjunction with regulatory management and clinical teams.
BIOSITE INC., San Diego, CA
$300 million company renown for rapid, high-capacity antibody development, enabling high throughput screening of potential
diagnostic markers and cost-efficient development of high affinity antibodies for use in commercialized products.
Senior Director, Clinical & Medical Affairs Group 2006-2008
Advanced new product regulatory clinical studies, post approval studies, and pre-clinical studies and evaluations.
Developed database, validation, and reporting systems for clinical and R&D. Supervised 2 biostatisticians and
clinical data management staff of 4.
• Revised standard operating procedures (SOPs) to maintain regulatory compliance and to increase focus on
corporate objectives.
• Successfully completed 9 clinical study statistical analysis plans, analyses, and reports that were integral to
FDA and EU (CE marker) submissions.
• Trained staff on statistical methodologies, sample size calculations, and preparation of statistical analysis
plans used for pre-clinical, clinical, and post-clinical (outcomes) studies for cardiovascular point-of-care
assays (Troponin, CKMP, BNP), pre-independent development evaluations, and production registration
applications.
• Developed multi-parameter (biomarkers, patient demographics, pathology) logistic regression models
approach to evaluate various biomarker assays in plasma to be used on Triage point-of-care assay
platform, which led to 3-biomarker panel for diagnosis of community-acquired sepsis in patients
presenting in emergency rooms.
BECKMAN COULTER INC., San Diego, CA
Company develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing
performed in hospitals and critical care settings.
Senior Staff Biostatistician, Regulatory & Clinical Affairs 1996-2006
Supported product development, commercialization, troubleshooting and manufacturing of diagnostic assays,
instrumentation and information systems. Assessed and mitigated risk.

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858.357.6491 - robert.e.parson@gmail.com
HYBRITECH INCORPORATED (Eli Lilly & Co.), San Diego, CA
Biotechnology Company that developed and marketed monoclonal antibodies used to make diagnostic and medical monitoring
tests to identify various infectious, viral and cancer-related diseases, infertility, allergies, and pregnancy.
Director, Biostatistics, Clinical & Regulatory Affairs 1990-1996
Oversaw biostatistics, clinical data management, and managed care planning. Supervised clinical and regulatory
staffs. Managed manufacturing, quality control, research, and development. Created health economic models.
CERTIFICATIONS
ASQ Certified Reliability Engineer, ASQ Certified Quality Engineer and Certified Healthcare Executive
PROFESSIONAL AFFILIATIONS
International Society for Pharmaco-economics and Outcomes Research
Organization Memberships Drug Information Association
American Society for Quality – Senior Member Status
Clinical Laboratory Management Association
American Association for Clinical Chemistry
American Statistical Association
Society for Controlled Clinical Trials
Society for Medical Decision Making
Clinical Data Management Association
COMPUTER SKILLS
Statistical Analysis System (SAS),RS-1, Data TreeAge Software, Medcalc, nQuery and PASS Sample Size Estimates,
Microsoft Word, Excel, Project, Visio, SQL Database, Crystal Ball