M.D. in Urology @
Freie Universtät Berlin, Germany
High performing, results-oriented medical executive with extensive global pharmaceutical industry experience in a wide variety of therapeutic areas, including analgesics, anti-infectives, dermatology, gastroenterology, tissue regeneration, and consumer health products. Successful in building and managing large teams to exceptional performance and consistently developing top talent in organizations. Visionary strategist possessing great passion for the business with the ability
High performing, results-oriented medical executive with extensive global pharmaceutical industry experience in a wide variety of therapeutic areas, including analgesics, anti-infectives, dermatology, gastroenterology, tissue regeneration, and consumer health products. Successful in building and managing large teams to exceptional performance and consistently developing top talent in organizations. Visionary strategist possessing great passion for the business with the ability to effectively communicate and integrate scientific and business terminology in multiple languages. Strong history of success in leading focused teams on science and business critical issues and opportunities. Languages: native Spanish, fluent in English and German, intermediate Portuguese, and basic Italian and French.Has also attended sample seminars such as:
• Role of the Leader, Novartis Corporation, Boston, MA, USA
• Clinical Statistics for Non-Statisticians, DIA, PA, USA
• Executive Leadership Program, Wyeth Corporation, Princeton, NJ, USA
• Global Leadership Program, Wyeth Corporation, Princeton, NJ, USA
• Leading the Global Organization, Thunderbird University, USA
• Globalization: Merging Strategy with Action, Thunderbird University, USA
Therapeutic Area Lead, Global Medical Affairs and Clinical Development @ Globally head the Medical and Clinical strategy for analgesics on innovation, early stage, late stage and geographical expansion projects. From March 2013 to Present (2 years 10 months) Private Consultant @ Medical Affairs Consultancy for the Pharmaceutical Industry with special focus on bridging science and business From July 2012 to February 2013 (8 months) Assistant Vice-President, Head Global Medical Affairs @ Direct and manage all aspects of global scientific support for therapeutic areas: pain management, respiratory, GI/topical, nutritional supplements.
• Collaborate with the Rx / OTC Switch Team to provide strategic medical input to potential switch projects.
• Analyze and medically assess in-licensing product candidates to determine appropriateness and alignment with company strategy. Participate on due diligence concerning opportunities in the allergy and respiratory areas.
• Provide medical input to clinical trial protocols in all therapeutic areas to ensure appropriateness of endpoints and compliance with clinical practices.
• Review and approve labeling, claims and promotional activities, including support for global affiliates.
• Company representative to Consumer Healthcare Products Association; interact with member companies and provide significant input to preparations for FDA advisory committee meetings.
• Manage medical safety as key participant on Safety Review Team. From June 2008 to June 2012 (4 years 1 month) Head Global Medical Affairs @ From 2008 to 2011 (3 years) Head Global Medical Affairs @ Headed the Global Medical Affairs operation for all products worldwide including the US (analgesics, respiratory, dermatics, gastrointestinal, dietary supplements).
• Established the global medical team leveraging expertise and integrating associates from countries around the world.
• Created and substantiated countless claims for several brands through data mining, literature reviews and data recycling.
• Delivered over a hundred journal publications, abstracts/posters and medical-marketing materials for all global brands.
• Medically evaluated and conducted due diligence on internal and acquired portfolio of products (BMS OTC acquisition) for in-licensing product and technology candidates to determine the viability in the OTC area.
• Initiated and implemented a successful global electronic interactive knowledge management tool called, OTC-AskMe; recognized by senior leadership as adding to the business as a platform for growth. From 2004 to 2008 (4 years) Assistant Vice-President International Medical and Clinical Affairs @ Managed International Medical Affairs and Clinical Research operation for all worldwide products excluding the US (analgesics, respiratory drugs, dermatics, gastrointestinal, dietary supplements). Initially hired and promoted from Senior Director International, Medical and Clinical Affairs.
• Led a global multi-disciplinary team that conducted an in-depth study analysis for a potential Rx to OTC switch including clinical trials, label comprehension studies, and consumer selection/ de-selection studies.
• Medically evaluated in-licensing product / technology candidates to determine the viability for OTC use.
• Chaired an international task force that successfully developed a model for switching products to OTC in Europe.
• Produced several Clinical Expert Reports for the submission of product registrations in Europe, either through mutual recognition or local procedures.
• Reviewed and approved labeling and advertising for all international products outside the US. From 2001 to 2004 (3 years) Senior Director New Products @ Recruited to work with new project development teams providing medical input on global business opportunities in the areas of Orthopedics, Cardio-Vascular, Urology and Hematology.
• Led a project team of Scientists that identified new applications and expand market opportunities for Alloderm®.
• Completed Medical-Marketing assessments and Business Cases including market analysis and forecasts for Cartilage Regeneration, Bone Substitution, Ligaments Reconstruction, Meniscus Replacement, Coronary Artery Bypass Grapts (CABG) and Peripheral Vascular Grafts. From 2000 to 2000 (less than a year) Director New Products Anti-Infectives @ Selected to lead the medical effort for all early stage Anti-Infective products. Developed assessments, participated actively on project teams, and contributed to the development of Target Product Profiles and Clinical Development Programs. Promoted from Scientific Director Anti-Infectives.
• Directed Phase IIIB and Phase IV clinical strategies and strategic medical communication for anti-infectives including publication plans, symposia, and congress activities.
• Chaired the company’s Anti-Infectives Product Opportunity Evaluation Team (P.O.E.T.).
• Provided medical input to Product Development Teams for pre-clinical efficacy and early phase clinical development.
• Worked closely with Business Development and assessed numerous business opportunities for the Anti-Infective area.
• Promoted from Scientific Director Anti-Infectives. From 1997 to 2000 (3 years) Pharma General Manager @ Promoted to relocate and manage Hoechst Marion Roussel Affiliate in Ecuador with full P&L responsibility and 180 employees including Marketing, Sales and Production/Manufacturing.
• Led the successful integration of Ecuadorian Affiliates following the acquisitions of Roussel (1993) and Marion (1995).
• Managed the export of the Hoechst line of products to all Latin American affiliates.
• Founded Cox Ecuatoriana S.A., a company created for distribution of generics including all aspects of establishing a separate legal entity, meeting all regulatory requirements to manufacture and distribute a generic line of analgesics, diuretics and anti-diabetics. From 1993 to 1996 (3 years) International Market Manager @ Managed and coordinated business marketing activities between the corporate office and South America including Venezuela, Argentina, Paraguay, Uruguay and Chile. Discussed and established agreement on Business Plans with affiliates.
• Led and prepared successful launch of several anti-infectives including Modivid.
• Developed post-marketing strategy for 3rd generation cephalosporins, Claforan.
• Created and built Key Opinion Leader network for speaking engagements and symposiums throughout Europe and South America to effectively support the Anti-Infectives business. From 1990 to 1993 (3 years) Held various positions of increased responsibility @ Responsible for Anti-Infectives, Cardio-Vascular and Analgesics. Managed Product Licensing and Regulatory Affairs including acting as Public Relations Advocate with Key Opinion Leaders. Trained and instructed Field Force. From 1985 to 1990 (5 years) Urologist @ Managed clinical and surgical treatment of hospitalized and ambulatory patients with urological diseases. Trained Medical residents in Urology. From 1982 to 1985 (3 years)
Business Administration Diploma, Business Administration @ European Business School (IDB), Frankfurt, Germany From 1992 to 1993 M.D. in Urology, Urology @ Freie Universtät Berlin, Germany From 1979 to 1982 Doctor of Medicine (M.D.), General Medicine and Surgery @ Universidad Central del Ecuador From 1971 to 1978 Alberto Paredes-Diaz is skilled in: Clinical Development, Consumer Healthcare, Pharmacovigilance, Pharmaceuticals, Clinical Research, R&D, FDA, Product Development, Product Life Cycle Management, Global Marketing, Nutrition, Product Innovation, Biotechnology, Life Sciences, Research
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