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Welcome to Clinical Research Strategies, a management consultancy founded by an inside industry expert, providing highly specialized advice to life science executives, entrepreneurs, investors, and academic institutions.
Director / VP level Quality Assurance and Regulatory Affairs professional with loads of experience in international Class I - III medical device, manufacturing, and military defense / aerospace systems now looking for next career opportunity in the Pittsburgh area or virtual office. Candidate has exceptional qualifications to lead quality and risk programs, including developing quality systems by scratch, de-risking the business operations, improving the supply chain and manufacturing processes, and improving profits and market share. Experience leading teams and motivating the workforce. BS/MS in ME with MBA in Finance from top tier US program. Contact me for more details on this candidate.
"Well-designed and executed clinical trials have the highest chance of demonstrating a statistically significant benefit to win regulatory approval, securing reimbursement, changing clinical practice, and driving market adoption, but this is based on the premise that the product works, it can be manufactured, a demand exists in the marketplace, and its cost will be acceptable to end users."
Helping you navigate clinical research, regulatory, and economic impact pathways to solidify investment decisions.