Guillermo Millicovsky

Background

About Guillermo Millicovsky

20+ years of leadership, management, drug safety evaluation 30+ years of scientific mentoring Successfully Preclinical Safety Leader, 30+ NME’s Critical results: 19 successful IND’s and 15 FIH’s Expertise in preclinical development across multiple therapeutic areas (TA's) Recognized leadership and process expertise from Discovery to Registration Led de-risking processes for multiple backup molecules Played significant roles as preclinical peer reviewer, mentor/trainer during 18+ years Effectively led project teams, built and sustained business-critical relationships Successfully led FDA interactions, meetings, and communications over 20+ years Directed/managed preclinical laboratories and projects within big Pharma Broad PCS experience in Toxicology, BA/DMPK, Pathology, Process Chemistry GLP/SOP trainer within Pharma Successfully trained FDA site inspectors and Pharma GLP compliance teams Key contributor to FDA/Pharma Task Groups for revisions of Pregnancy Labeling Effective communication, hands-on team leadership, interpersonal skills Focus on transparent customer relations and on-time deliverables Excellent sponsor-CRO interactions, study monitoring, scientific study reviews Experienced scientist, expert toxicologist, effective regulatory strategist, and confidence-inspiring leader. In-depth understanding of drug development processes, design and testing of effectiveness and biocompatibility of medical/surgical devices. A hands-on team builder with a track record of successful communications, consistency in meeting project goals and timelines. Able to effectively integrate complex data, generate “out-of-the-box” approaches to assure timely issue resolution, implement novel scientific paradigms to de-risk issues in critical paths, drive to exceed goals and expectations, and a firm believer in proactive planning. Enthusiastic and engaged team member, leader, and mentor.