Expert Details
Pharmaceutical, Drug, Medical Device, and Management
ID: 735569
California, USA
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 2017 | Degree: Juris Doctor (JD) | Subject: | Institution: University of San Diego |
| Year: 1995 | Degree: Post-doctoral Fellowship | Subject: Drug Development | Institution: University of North Carolina |
| Year: 1993 | Degree: MBA | Subject: | Institution: American Graduate School of International Management / Thunderbird |
| Year: 1991 | Degree: Doctor of Pharmacy (Pharm.D.) | Subject: | Institution: University of Arizona |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2008 to Present | Employer: Undisclosed | Title: Strategic Management and Clinical Consultant | Department: |
Responsibilities:Product/corporate strategist for pharmaceutical, biotech, and medical device companies. Performs comprehensive due diligence, assessing and optimizing companies’ strategy, operations and infrastructure, talent, financials, and product development for maximum revenue growth and capital savings. Builds internal teams, 3rd party networks, and alliance partnerships and provides hands-on management and leadership where needed. Conducts clinical, compliance and program audits, develops KPI’s and SOPs, and updates processes based on best practices. Handles external communications, relationship/alliance management, and issue resolution. Works closely with executive leadership and Boards providing counsel and support as they steer company vision and prepare company for extended development or exit. |
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| Years | Employer | Title | Department |
| Years: 2016 to 2017 | Employer: University of San Diego School of Law | Title: | Department: Entrepreneurship Clinic |
Responsibilities:Provided transactional legal services targeting high technology business start-ups and other emerging growth companies regarding business entity formation, financing regulations, term sheets, pitchdecks, drafting of investment agreements and corporate documents, and protection of intellectual property. |
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| Years | Employer | Title | Department |
| Years: 2013 to 2014 | Employer: HUYA Bioscience International | Title: Chief Operations Officer/ Vice President, Clinical Development | Department: |
Responsibilities:Available upon request. |
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| Years | Employer | Title | Department |
| Years: 2008 to 2015 | Employer: Novaquest - Quintiles Transnational | Title: Vice President | Department: Strategic Partnering and Clinical Development |
Responsibilities:Available upon request. |
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| Years | Employer | Title | Department |
| Years: 2006 to 2010 | Employer: Pacific Community Ventures | Title: San Diego Business Advisor | Department: |
Responsibilities:Consulted with various entrepreneurial start-up companies in the greater San Diego area providing the tailored strategic and operational guidance needed to help companies scale and remain viable entities. Mentored founders regarding strategic business opportunities, marketing/commercial initiatives, organizational structure, financial management and executive leadership. |
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| Years | Employer | Title | Department |
| Years: 2001 to 2007 | Employer: Amylin Pharmaceuticals | Title: | Department: Medical Affairs, Clinical Development, Outsourcing & Procurement |
Responsibilities:Available upon request. |
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| Years | Employer | Title | Department |
| Years: 1995 to 2001 | Employer: Quintiles Inc. | Title: | Department: Global Project Management |
Responsibilities:Oversaw business accounts for 80+ domestic and international pharmaceutical companies. Built and managed large global teams (200+ employees) spanning Asia Pacific, South Africa, Latin America, North America and Europe. Negotiated and managed program budgets in excess of $500M. Led corporate initiatives for improving efficiencies; built financial forecasting system for Project Managers and built and led new processes for streamlining project management across programs and international offices. Member of the Senior Management Team and various steering committees. |
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| Years | Employer | Title | Department |
| Years: 1993 to 1995 | Employer: Glaxo Pharmaceuticals | Title: Senior Clinical Research Scientist/Fellow | Department: Medical Affairs |
Responsibilities:Available upon request. |
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International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 1995 to Present | Country / Region: Too numerous to list | Summary: Expert has worked professionally, in the pharmaceutical industry, in approximately 45+ countries |
Career Accomplishments
| Associations / Societies |
|---|
| International Law Journal President, Health Law Society International Association of Lawyers (UIA) American Diabetes Association American Heart Association |
| Licenses / Certifications |
|---|
| State Bar of California Arizona Board of Pharmacy California Board of Pharmacy |
| Professional Appointments |
|---|
| Board of Directors, Women's Financial Academy Business Advisory Board, Cures Within Reach Scientific Advisory Board, Cures Within Reach Steering Committee, Intarcia Scientific Advisory Board, Intarcia Steering Committee, Tethys Bioscience Business Advisory Board, Concepts Worldwide External Advisory Board Management, Amylin Pharmaceuticals FDA Advisory Board Prep Team, Amylin Pharmaceuticals FDA Advisory Board Prep Team, Glaxo Wellcome |
| Publications and Patents Summary |
|---|
| Publications: 9 |
Language Skills
| Language | Proficiency |
|---|---|
| German | Conversational (limited at present) |
Fields of Expertise
drug development, biomedical device, biopharmaceutical product development, pharmaceutical drug, FDA medical device regulation, medical device clinical research, medical device liability, medical device product development, pharmaceutical industry, pharmaceutical launch, pharmaceutical life cycle management, drug, drug product approval, drug regulation, Food and Drug Administration drug registration, European drug registration, over-the-counter drug regulation, clinical research, clinical research management, project management, health product liability, medical malpractice, medical malpractice evaluation, pharmacy malpractice, pharmacy operations, pharmacy practice, international development, international health, international operations, international research