Experience

Self-employed

• Real Estate
• 1 - 100 Employee

• Consulting Clinical Development and Pharmacovigilance Physician

  • Oct 2016 - Present

• Consulting Global Safety Officer

  • Oct 2016 - Nov 2018

  Broad-ranging world-wide safety responsibilities for BLA applications from prior to submissions until after approvals (dupilumab, sarilumab), from pre-phase 1 until post-marketing, for novel immunotherapeutics in inflammatory, immunologic and infectious diseases.



Consumer Products Consultants, LLC

• President and Founder

  • Nov 2015 - Present

  Consultant, Medical Safety, Product Safety for Drugs, Devices, Cosmetics, Nutritionals, Consumer Goods; Clinical Development Phases 2-4; WW Regulatory Submissions for Drugs and Devices; Quality Defect Medical Consequence Assessment; Regulatory Inspection Preparation Consultant, Medical Safety, Product Safety for Drugs, Devices, Cosmetics, Nutritionals, Consumer Goods; Clinical Development Phases 2-4; WW Regulatory Submissions for Drugs and Devices; Quality Defect Medical Consequence Assessment; Regulatory Inspection Preparation



Sarepta Therapeutics

• United States
• Biotechnology Research
• 700 & Above Employee

• Global Medical Safety Officer

  • Nov 2018 - Jun 2019

  On-site Medical Safety Physician with responsibility for 3 major clinical development projects for treatment of Muscular Dystrophy including gene therapy and post-marketed pharmacovigilance for one MD drug. On-site Medical Safety Physician with responsibility for 3 major clinical development projects for treatment of Muscular Dystrophy including gene therapy and post-marketed pharmacovigilance for one MD drug.



Sanofi Genzyme

• Global Medical Safety Officer

  • Oct 2016 - Nov 2018

  Broad-ranging world-wide safety responsibilities for BLA applications from prior to submissions until after approvals (dupilumab, sarilumab), from pre-phase 1 until post-marketing, for novel immunotherapeutics in inflammatory, immunologic and infectious diseases. Broad-ranging world-wide safety responsibilities for BLA applications from prior to submissions until after approvals (dupilumab, sarilumab), from pre-phase 1 until post-marketing, for novel immunotherapeutics in inflammatory, immunologic and infectious diseases.



Johnson and Johnson, Family of Consumer Companies

• Senior Director, Medical Safety Officer, Office of Consumer Medical Safety, JNJ Consumer Companies

  • Aug 2005 - Mar 2015

  While transitioning responsibilities from R&D Women's Health, was named Medical Safety Officer for JNJ Family of Consumer Companies. As the position and responsibilities grew, became responsible WW for all Consumer cosmetics, devices, drugs, and nutritionals, accounting ~$ 9 billion sales across all companies making up JNJ's Consumer Division. Worked closely with R&D, QA and Regulatory in all phases of product development and post-marketing. Introduced "Safety by Design" concept into R&D. Extended PV with predictive analytics. Show less



Johnson and Johnson Group of Consumer Companies

• Executive Director, Worldwide R&D Women's Health

  • 2003 - 2006

  Led development of drugs, devices and cosmetics for applications in Women's Health. Expanded K-Y Brand line of products, tripling sales in 3 years. Performed rapid proof-of-efficacy trial on potential NDA drug, demonstrating a very low statistical chance of potential FDA approval, saving > $25 MM and 2 years development before project cancellation. Represented JNJ Consumer with FDA inspection for safety-related issues, leading to NA Medical Safety Officer position. Led development of drugs, devices and cosmetics for applications in Women's Health. Expanded K-Y Brand line of products, tripling sales in 3 years. Performed rapid proof-of-efficacy trial on potential NDA drug, demonstrating a very low statistical chance of potential FDA approval, saving > $25 MM and 2 years development before project cancellation. Represented JNJ Consumer with FDA inspection for safety-related issues, leading to NA Medical Safety Officer position.


Pharmacia Corporation (fka Pharmacia & Upjohn and The Upjohn Company)
• Director, R&D Women's Health and Urogynecology

  • 1999 - 2003

Pharmacia
• Wholesale Drugs and Sundries
• Director, R&D Women's Health, Urology and Antiinfectives

  • 1991 - 2003

Upjohn / Pharmacia
• Director, AntiInfectives/Urogynecology

  • 1991 - 2003

Parke-Davis
• United States
• Facilities Services
• 1 - 100 Employee
• Director of Clinical Research, Infectious Diseases

  • 1987 - 1990