Pharmaceutical and Biotechnology Medical Affairs Consultant - Ophthalmology, Rheumatology, Dermatology, Cardiology, and Gastroenterology

Expertise

• Strategic Advisor and support in in multiple therapeutic areas including: Ophthalmology, Rheumatology, Dermatology, Cardiology, and Gastroenterology.
• Clinical and Scientific Reviewer of promotional and advertising materials for existing brands, new products, press releases, educational materials, field training materials.
• Scientific content and clinical development for Fortune 500 companies.
• Post marketing protocol writing.
• Investigator-Initiated Trial (IIT) management.
• Publication planning.
• Document development and review: Investigator brochures, submission's for NDAs and other regulatory documents.
• Working with key opinion leaders in diverse range of specialties as well as interfacing with marketing, regulatory affairs, pre-clinical, and CMC.

Experience

Independent Consultant, Director and Principal, 2008 - Present

Projects

• Writing Investigator: Initiated study protocols.
• Writing Investigator: Initiated regulatory documents; Investigator IND filing to FDA.
• Writing Investigator: Brochures
• Scientific content development for medical education.
• Focused clinical Investigating support that involved initiated studies by providing protocol writing and IRB filing support.
• Develop and review of medical education materials.
• Provide medical content review for items reviewed as part of corporate legal, medical, and regulatory review process.
• Specializing in medical communications developing strategies to effectively transfer information for products in early to late stage development; includes publication, medical education, advocacy, and opinion leader development plans.
• Over 15 years supporting clients with healthcare and research experience.

Bausch and Lomb, Irvine, CA, Director Global Medical Affairs, 2011 - 2013

• Manage Investigator who initiated study programs including strategy for areas of interest.
• Manage phase 4 clinical trials (including Over the Counter products) from strategy to implementation including oversight of CROs.
• Develop and oversee product and life cycle clinical Advisory Boards.
• Developed strategy and implemented communication plans for timely and accurate dissemination of scientific data.
• Developed organizational SOPs.
• Confirmed scientific accuracy for all media developed within the organization.
• Committee Lead and budget oversight for all pharmaceutical division charitable requests, educational grant applications, and Investigator of initiated studies from external customers globally to ensure educational objectives of the division were met.
• Provide scientific expertise to internal and external customers.

ISTA Pharmaceuticals, Irvine, CA, Medical Affairs Manager, 2009 - 2011

• Identified, established, and maintained relationships with medical thought leaders and clinical decision makers in academic and managed care organizations.
• Served as communication link with customers in the scientific and health care communities.
• Served as technical expert on disease entities and therapeutic profile for internal and external customers.
• Identified and profiled candidate investigators for customer-initiated and corporate clinical trials.
• Participated in competitive intelligence activities during scientific congresses.
• Developed regional programs for the dissemination of product information to Ophthalmologists, Optometrists, and Allergists.
• Trained sales representatives on ongoing clinical trial data and current scientific information.

Amgen, Thousand Oaks, CA, Director Scientific Affairs, 2000 - 2008

• Directed a staff of 8 - 15 employees (including Ph.D.'s, Pharm.D.'s and support staff) and oversaw all business operations for the department, including hiring, training, motivating, and evaluating all staff.
• Managed diverse product portfolio across multiple disease states in inflammation franchise.
• Developed strategy and implemented communication plans for timely and accurate dissemination of scientific data.
• Developed departmental SOPs for publication planning, slide management, medical education and scientific exchange with external customers.
• Confirmed scientific accuracy for all media developed within the Inflammation franchise.
• Reviewed educational grant applications from external customers to ensure educational objectives of the department were met.
• Provide scientific expertise to internal and external customers.
• Partner with medical Information on development and reviewing standard letter responses to inquiries from customers.
• Led department level integration during Immunex acquisition; designed new organization structure including integrating staff and systems, drawing upon best practices within both organizations to develop a world class department.

Honors & Publications

Academic and Professional Affiliations

• The Association for Research in Vision and Ophthalmology - ARVO
• American Society of Cataract and Refractive Surgery - ASCRS
• Arthritis Foundation
• American College of Rheumatology
• American Association for the Advancement of Science
• American Society of Hypertension
• Heart Failure Society of America
• American Heart Association, High Blood Pressure Council
• American Heart Association, Basic Science Council
• American Association for Cancer Research
• Women in Cancer Research
• Board of Directors Research and Education Foundation/American College of Rheumatology, Industry Roundtable representative
• Board of Directors New York Chapter of the Arthritis Foundation

Publications and Patents

• Author and Co-Author of 19 publications, several presentations and granted 3 U.S. patents.

Education

• Ph.D. Molecular Biophysics, University Of Texas Southwestern Medical Center, Dallas, TX
• B.S. Chemistry (Magna cum Laude), University of Tulsa, Tulsa, OK