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Professional Experience: Codman Franchise Medical Leader, Johnson and Johnson Medical, Raynham MA, USA 2015-present Duties and responsibilities: o Responsible for Medical Affairs, front-end innovation, NBD, and life cycle management for Codman Global Business. A $700mil business with in JnJ medical Device sector o Hold a position on the Medical Affairs Leadership Team with in JNJ Medical Device Medical affairs COE as well as a member of the Codman Management Board of directors o Key responsibility included identifying and driving innovation in support of the new product development process for the Codman global business, through application of deep clinical, surgical and research expertise while working closely across and with clinical, R&D, regulatory and commercial functions and partners Interim Codman Global Clinical Head, Johnson and Johnson Medical, Raynham MA, USA 2016-2017 Duties and responsibilities: o Responsible for Codman Global Clinical Strategy and Clinical operation o Worked closely with regulatory and clinical partners to design, submit, 510k, HDE, IDE, PMA, PCMF studies to FDA, EU, Japanese regulatory bodies as well as execution in related markets o Managed EU, Japan, Chinese, and US clinical study teams involved in all clinical studies for neurosurgical and neurovascular portfolios INSTITUTION AND LOCATION DEGREE YEAR FIELD OF STUDY Pomona College, Claremont, CA BA 1997 Neuroscience Stanford University, Stanford, CA PhD 2005 Neuroscience Stanford University, Stanford, CA MD 2008 Medicine o Meet with FDA on a regular basis to support submissions and advocate for industry around medical device regulations o Establish a strong working relationship with Carlos Pena, Branch Chief of Neurological Disease sector at FDA to speed application approval process o Worked closely with global KOLs to ensure enrolment progression and protocol adherence was maintained in all operating company study’s o Partnered with Health Economics teams to develop and integrate evidence strategy into clinical studies design. Often in a market specific manner to support reimbursement in that country North Asia Medical Affairs, Clinical, and Safety Director, Johnson and Johnson Medical, Seoul South Korea 2014-2016 Duties and responsibilities: o Responsible for all medical affairs, clinical operations, and safety in North Asia (Korea, Hong Kong, and Taiwan) directed the operational function of the medical affairs, clinical and safety organization in North Asia to achieve organizational as well as regional goals and objectives o Responsible for the design, development and implementation of programs related to educational, promotional and reporting materials across all the Medical Device sectors (Global surgery, orthopedics, Diabetes, Vision care, Wound care) portfolios and products related to early and late phase trials, solicited and non-solicited studies, medical information and publications o Interfaced with key members of the business and Research & Development organizations to drive clinical strategy and contribute to success across Global surgery and Global orthopedics portfolios o Worked closely with business teams to provide medical and scientific support for all product portfolios and support KOL interactions o Worked to ensure the highest levels of product safety vigilance was maintained across all product lines and clinical studies to ensuring patients safety o Partnered with KFDA to improve regulatory and safety systems for the Korean medical device industry o Worked closely head of Hong Health and safety, David Chen, to improve product surveillance by building collaborations with local KOL and hospitals. As well as initiated a training program for new product release to improve user competence and patient safety o Partnered with Asia pacific Innovation teams to identify new technologies by working with regional KOLs or directly with small and large companies. These efforts mainly focused on Korea, Japan and China o Held a position on the North Asia leadership team and Board of Directors, playing a key role in strategy development by providing deep clinical and medical insight as well as perspective, to shape NA/AP business strategy o The position reported into both the Area Sr VP for North Asia and Asia Pacific, the global Medical Affairs COE and had and a cross functional relationship with the Regional Senior Safety Officer for Medical Safety AP, on safety-related issues.
Neuroscience, Basic and Clinical science.