`
`www.linkedin.com/in/dat-
`nguyen-7617a04 (LinkedIn)
`
`Top Skills
`Clinical Development
`Project Management
`Clinical Trials
`
`Dat Nguyen
`
`Director, Medical Communications at Corcept Therapeutics
`Menlo Park, California
`
`Summary
`-Extensive operational knowledge of drug development process
`and clinical study management from initial study design (including
`registries) to publication of study results
`-Effective in matrix environments working with Marketing, Sales,
`Medical, Legal, Regulatory and Research and Development
`-Successful development of strategic, scientific, and commercially
`aligned communication and publication plans to publish and
`disseminate clinical/scientific data
`-Proficient in current practices in medical and regulatory affairs,
`drug development, FDA and regulatory guidelines (i.e., PhRMA
`guidelines, ACCME, ICJME etc.)
`-Strong leadership and project management skills, ability to work
`collaboratively in cross functional teams in addition to operating
`independently
`-Trained in Six Sigma and Change Management methodologies to
`facilitate organizational efficiencies and process improvements
`-Diverse therapeutic knowledge: Transplantation, Immunology,
`Urology, CNS, Metabolism (Obesity), Cardiovascular, Orthopedics
`(Hand Surgery)
`
`Specialties: Medical Affairs, Drug Information, Publications, Clinical
`Development, Project Management, Registries
`
`Experience
`
`Corcept Therapeutics
`6 years 8 months
`Director, Medical Communications
`January 2017 - Present (3 years 5 months)
`Menlo Park, CA
`
`Associate Director, Medical Communications
`October 2013 - January 2017 (3 years 4 months)
`Menlo Park, CA
`
`Page 1 of 3
`
`1
`
`TEVA1072
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`
`
`
`PRA International
`Scientific Affairs Director, Late Phase Services
`June 2011 - September 2013 (2 years 4 months)
`Supports global and regional post-approval studies by planning and
`conducting safety-surveillance studies, large simple trials, registries, restricted
`access programs, risk management programs, and diagnostic and biomarker
`research.
`
`Auxilium Pharmaceuticals
`Assoc. Director,Medical Affairs
`April 2008 - June 2011 (3 years 3 months)
`-Established the foundation of the Medical Affairs department by implementing
`policies and procedures to ensure proper compliance with current regulations
`while servicing the needs of a growing company
`-Instituted and established the Drug Information Center, Educational and
`Research Grants Portal, and enhanced the Patient Assistance Program
`oCreated product information support documents, including position papers
`and standard response letters
`oManaged investigator-initiated research proposals through review/ approval
`process, while identifying and supporting research opportunities for future
`collaboration
`oSupervised the selection/support of independent accredited medical
`education activities to ensure that the scope is consistent with the company
`educational objectives, and compliant with all applicable guidelines and
`regulations
`-Medical representative & signatory for promotional review of marketing
`materials to ensure evidence-based approach, medical accuracy and fair-
`balance
`-Involved in publication strategy and execution, including writing, reviewing
`and approving abstracts, posters, and manuscripts for scientific accuracy and
`adherence to regulations
`-Effectively collaborated with Key Opinion Leaders, external advisors, and
`professional societies to address medical and commercial needs
`-Served as a scientific resource for the commercial team by attending scientific
`meetings, conducting competitive product analysis, and identifying market
`opportunities
`-Executed and managed a large observational post-marketing registry
`
`Bristol Myers Squibb
`Protocol Manager
`
`Page 2 of 3
`
`2
`
`
`
`March 2006 - April 2008 (2 years 2 months)
`Functioning as a project manager for multiple Phase III global clinical trials
`across therapeutic areas (Immunology-Transplant; Metabolism-Obesity;
`Cardiovascular - DVT)
`
`Novartis
`Sr. Clinical Research Scientist
`July 2002 - March 2006 (3 years 9 months)
`
`Education
`Rutgers University
`· (2002 - 2004)
`
`Albany College of Pharmacy and Health Sciences
`PharmD · (1996 - 2002)
`
`Page 3 of 3
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`3
`
`
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