Over 25 years of experience in US and international operations with a broad background in the pharmaceutical and medical device industries. Highly skilled across a broad range of operational areas. Perfect fit is a small, fast paced, development environment.Previously with Agile Therapeutics, Inc., a publicly traded commercial pharmaceutical company that, in August 2024, merged with Insud Pharma, S.L., a global pharmaceutical group based in Spain.With Agile Therapeutics for over 15 years as a key member of a small drug development team. Held a wide variety of roles and developed into a crucial resource across several functional areas. Most recently Senior Vice President and Chief Corporate Planning and Supply Chain Officer. Previous roles were Senior Vice President of Enterprise Planning and Information Management, and head of the Regulatory and CMC groups.Key member of CMC team during 15-year development period. Initially, major contributor to transdermal product formulation, product design, packaging design and process development activities. After product approval in February 2020, built team to validate manufacturing process and build commercial supply. Built full supply chain to support product launch. Expanded and led CMC team while taking on the role of specialist, frequently tasked to lead internal and external teams to solve a wide range of difficult CMC challenges. Previously key member of Regulatory team. Engaged in all FDA interactions during 7-year review period. Planned, organized and prepared initial NDA submission and, after two CRLs, two subsequent resubmissions. Developed response strategy and organized work teams to respond to FDA Information Requests. Participated in several formal and ad hoc meetings with FDA. Participated in two levels of Formal Dispute Resolution, and led CMC effort to support resulting clinical trial. After successful trial outcome, participated in Advisory Committee Meeting. Led process to prepare CMO for PAI. Ultimate result was FDA approval of company's first commercial product, Twirla.Owner of IT. Evaluated, selected and managed MSP. Responsible for full scope including strategic planning, cybersecurity, compliance, data safety, user resources, budget. Conducted regular business reviews, presented security and compliance status to Audit Committee. Principal of R. G. Conway and Associates, an independent consulting firm. Began career in healthcare with Johnson & Johnson and later joined a J&J supported venture-backed medical device company operating as President and Chief Operating Officer.
Listed skills include Pharmaceutical Industry, Strategic Planning, Strategy, Cross Functional Team Leadership, and 14 others.