PSI CRO AG, a global contract research organization

Senior Legal Counsel

• Worked with internal teams and pharmaceutical and medical device clients to conclude clinical trial and related agreements in countries all over the world
• Managed internal compliance issues, training and advised on general legal issues
  

Morgan Lewis & Bockius LLP

Commercial Litigation Association

• Represented clients on a number of complex commercial matters
  

• Assisted several clients with customized template development for large, complex ex-US clinical trials, including clinical trial agreement forms for Asia, Europe and Africa
• Lead Attorney for Entasis Therapeutics Inc.’s CS2514-2017-0004  clinical study
• Negotiated clinical services agreements, including Software as a Service agreements with multiple CROs/service providers for clinical studies in Europe and the U.S.
• Assisted several mature biopharmaceutical companies in developing agreement forms for use with GMP services providers, including clinical development and manufacturing agreements. Negotiated clinical development and manufacturing agreements and other GMP services agreements counter to various CMOs
• Negotiated Investigator-initiated Research Agreements (involving multiple drug companies and multiple drug products within the same agreement) with large healthcare organizations in Australia and Europe