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Summary
Accomplished senior management executive. Twenty years of pharmaceutical industry experience in clinical research.
Over twenty years of experience in life sciences. Twenty years of supervisory, managerial and leadership experience in
research and industry. Rare blend of scientific, operational and business knowledge. Leads a focused biometrics and
data management organization in a biotechnology company. Has lead a global biostatistics and data management
department with about 100 staff in large pharma. Experience in a Contract Research Organization setting, large
pharma, consulting, and small biotech companies. Experience in running own consulting business. Two doctoral
degrees and Master of Administrative Science degree with focus on Global Leadership and Administration. Currently
pursues Master of Biotechnology Enterprise and Entrepreneurship at The Johns Hopkins University.
 Scientific excellence:
 In depth knowledge of clinical research process.
 Accomplished and well-published scientist with two doctoral degrees.
 Over 100 publications in research journals and conference proceedings.
 Acted as a reviewer for international scientific journals.
 International academia experience including industry collaboration.
 In depth knowledge of industry and academia research practices.
 Led multidisciplinary scientific teams.
 Awarded research fellowships in Germany, Sweden and France.
 Biostatistics and data management expert.
 Phase I-IV clinical trial experience, including regulatory advice and claim support.
 Vast clinical due diligence experience.
 Observational research and large database analysis experience.
 Involved in setup and data analysis of patient registry data; member of NPS Short Bowel Syndrome Registry
Global Scientific Steering Committee.
 Member of NPS Investigator Initiated Trials Committee
 Member of NPS Publication Planning Committee.
 Member of NPS Clinical Oversight Committee.
 Involved in external data transparency and disclosure initiatives at GSK.
 Member of the GSK Data Disclosure Board; involved in publication planning.
 Collaboration with NIH.
 Operational excellence:
 Has drawn plans for biometrics process improvements at NPS.
 Gained NPS management approval for long term and mid-term biometrics strategy.
 Effectively works with pharmaceutical vendors.
 At GSK in charge of a department of about 100 members (five at director level).
 Involved in cross-unit collaboration within GSK.
 Member of GSK’s Change Advocate Network.
 Global resourcing champion.
 Successful in professional and scientific staff development both in industry and in academia.
 Vast experience with managing Phase I through IV clinical trials.
 Experienced in U.S., European and international regulatory submissions.
 Culturally aware, great proponent of harnessing diversity.
 Enthusiastic, motivational, dedicated, quality focused.
 Member of clinical development operations core transition team at Shire Pharmaceuticals
 Business excellence:
 Entrepreneurial, ran own consulting company.
 Creates business value by championing flexible business solutions.
 Effectively works in virtual company outsourcing models and in internal resourcing models.
 Involved in increasing clinical productivity and simplification initiatives within GSK.
 Focused on cost containment and control.
 Operates effectively under budgetary constraints.
 Experience in working on commercial partnerships in support of various business opportunities.
 At NPS has supported value proposition development for Gattex and Natpara.
 Provided support for all major GSK CH brands, including first in class Rx to OTC switches resulting in
worldwide product launches.
 Business development experience on the vendor’s side.
 A ‘big picture’ person valued for strategic advice
Therapeutic, Regulatory & Post-Marketing Experience
Rare diseases, Endocrine & Metabolic disorders including diabetes, Pulmonary diseases, Allergy, Cardiology,
Dermatology, Genitourinary disorders, Oncology & Hematology, CNS, Virology, Gastrointestinal diseases, Pain,
Addiction, Oral Care.
Due Diligence, Rx medicines, Biologics, Vaccines, Devices, Biomarkers, Medical Food, OTC medicines, Rx to OTC
switches, Direct-to-OTC, Nutritionals.
Registries, Quality of Life, Patient Reported Outcomes.
.

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linkedin summary

  • 1. Summary Accomplished senior management executive. Twenty years of pharmaceutical industry experience in clinical research. Over twenty years of experience in life sciences. Twenty years of supervisory, managerial and leadership experience in research and industry. Rare blend of scientific, operational and business knowledge. Leads a focused biometrics and data management organization in a biotechnology company. Has lead a global biostatistics and data management department with about 100 staff in large pharma. Experience in a Contract Research Organization setting, large pharma, consulting, and small biotech companies. Experience in running own consulting business. Two doctoral degrees and Master of Administrative Science degree with focus on Global Leadership and Administration. Currently pursues Master of Biotechnology Enterprise and Entrepreneurship at The Johns Hopkins University.  Scientific excellence:  In depth knowledge of clinical research process.  Accomplished and well-published scientist with two doctoral degrees.  Over 100 publications in research journals and conference proceedings.  Acted as a reviewer for international scientific journals.  International academia experience including industry collaboration.  In depth knowledge of industry and academia research practices.  Led multidisciplinary scientific teams.  Awarded research fellowships in Germany, Sweden and France.  Biostatistics and data management expert.  Phase I-IV clinical trial experience, including regulatory advice and claim support.  Vast clinical due diligence experience.  Observational research and large database analysis experience.  Involved in setup and data analysis of patient registry data; member of NPS Short Bowel Syndrome Registry Global Scientific Steering Committee.  Member of NPS Investigator Initiated Trials Committee  Member of NPS Publication Planning Committee.  Member of NPS Clinical Oversight Committee.  Involved in external data transparency and disclosure initiatives at GSK.  Member of the GSK Data Disclosure Board; involved in publication planning.  Collaboration with NIH.  Operational excellence:  Has drawn plans for biometrics process improvements at NPS.  Gained NPS management approval for long term and mid-term biometrics strategy.  Effectively works with pharmaceutical vendors.  At GSK in charge of a department of about 100 members (five at director level).  Involved in cross-unit collaboration within GSK.  Member of GSK’s Change Advocate Network.  Global resourcing champion.  Successful in professional and scientific staff development both in industry and in academia.  Vast experience with managing Phase I through IV clinical trials.  Experienced in U.S., European and international regulatory submissions.  Culturally aware, great proponent of harnessing diversity.  Enthusiastic, motivational, dedicated, quality focused.  Member of clinical development operations core transition team at Shire Pharmaceuticals  Business excellence:  Entrepreneurial, ran own consulting company.  Creates business value by championing flexible business solutions.  Effectively works in virtual company outsourcing models and in internal resourcing models.  Involved in increasing clinical productivity and simplification initiatives within GSK.
  • 2.  Focused on cost containment and control.  Operates effectively under budgetary constraints.  Experience in working on commercial partnerships in support of various business opportunities.  At NPS has supported value proposition development for Gattex and Natpara.  Provided support for all major GSK CH brands, including first in class Rx to OTC switches resulting in worldwide product launches.  Business development experience on the vendor’s side.  A ‘big picture’ person valued for strategic advice Therapeutic, Regulatory & Post-Marketing Experience Rare diseases, Endocrine & Metabolic disorders including diabetes, Pulmonary diseases, Allergy, Cardiology, Dermatology, Genitourinary disorders, Oncology & Hematology, CNS, Virology, Gastrointestinal diseases, Pain, Addiction, Oral Care. Due Diligence, Rx medicines, Biologics, Vaccines, Devices, Biomarkers, Medical Food, OTC medicines, Rx to OTC switches, Direct-to-OTC, Nutritionals. Registries, Quality of Life, Patient Reported Outcomes. .