Experience

Padagis LLC

• United States
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Associate Director

  • Jul 2021 - Present

  • Develop, review, and approve clinical trial strategy/designs considering the review of scientific literature and Key Opinion Leaders • Develop, review, and approve all clinical trial related documentation, including but not limited to investigator lists, protocols, case report forms, management plans, and clinical study reports, and module 2.7 and module 5. • Work cross-functionally with R&D, regulatory affairs, finance, quality, compliance, and legal • Develop and oversee clinical study budgets and timelines • Manage full-service Contract Research Organizations (CROs) and other third-party vendors • Manage clinical supplies life cycle from forecasting through destruction • Responsible for the overall management of multiple simultaneous clinical trials • Create and maintain clinical study tracking documents and databases • Facilitate the contracting process for the Clinical Affairs department. • Review vendor proposals and decide on the vendors to participate in clinical studies. • Develop clinical study submission strategies to present to FDA • Prepare materials for, attend, and lead meetings with FDA • Write Clinical FDA correspondence in support of ANDAs, NDAs and Rx-to-OTC switch products • Present key trial indicators (budget, timelines, risks) to executive management • Lead representative in the review and reporting to executive management of clinical documentation/findings for M&A activity • Research pipeline candidate products and report clinical trial specifications to Business Development • Manager to a team of 3 direct reports • Organize, manage, and present at investigator meetings • Serves as a 30(b)(6) corporate witness in patent litigation • Onboarding mentor for new employees to the Clinical Affairs Department • Manage the clinicaltrials.gov process for Rx drug division Show less



Perrigo Company plc

• Ireland
• Manufacturing
• 700 & Above Employee

• Associate Director, Clinical Affairs

  • Jul 2016 - Jun 2021

• Manager

  • Sep 2009 - Jun 2016

• Project Manager

  • Jan 2007 - Aug 2009



Altana

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Project Assistant

  • Jan 2002 - Jan 2007