Yiwei Zhao (赵轶薇) MD, PhD, MBA
Global Program Clinical Head, Immunology Clinical Development @ Novartis
About
Dynamic professional with medical/scientific training in Dermatology, 6-year research experience on drug discovery/development/gene therapies, an MBA in Health Sector Management and Marketing, and over 10 year pharmaceutical industry experience across Commercial, Medical and Clinical Development.
United States
Cambridge
Biotechnology
Clinical Medicine, Drug Discovery and Gene therapy, Marketing Analysis and Strategy, Hospital Administration, Biotechnology, Strategy, R&D, Market Analysis, Drug Discovery, Medicine, Clinical Trials, Clinical Development, Cross-functional Team Leadership, Lifesciences, Drug Development, Clinical Research, Life Sciences, Data Analysis, Pharmaceutical Industry, Medical Devices
Experience

Sr. Medical Director, Clinical Development Lead, Immunology
Waltham, Massachusetts, United States
Clinical Development Lead accountable for aIL-18 development strategy and program execution, overseeing the execution of the aIL-18 clinical development program in atopic dermatitis and defining LCI strategy

Medical Director, Immunology/Derm, Clinical Development
Cambridge, MA
• Served as clinical lead in a cross-functional team to lead the design of study protocols and develop clinical strategies for early and late-stage clinical development programs (including both small molecules and biologics) in support of the overall Development plan. • Oversight of clinical studies implementation, monitoring overall study integrity while working with Clinical Operations to ensure enrollment and timelines for key deliverables, • Served as the clinical representative in a cross-functional drug development matrix in contribution to the development of a rigorous, organization-level aligned Clinical Development Plan. • Served as clinical lead in regulatory filling (regulatory responses, discussions, etc.), including led pediatric clinical development strategy and plan and supported PIP and PSP regulatory documents development and submission • Acted as clinical publication lead to support congress presentations and manuscript development • Served as clinical lead in a cross-functional matrix to support due diligence projects

Associate Director, Medical Information, Global Medical Affairs
Cambridge, MA
The Global MedInfo lead to drive content development road-maps and execution for both marketed products and investigational compounds. Also served as interim lead for the Patient Information Service.

Manager, Emerging Market, Commercial
Weston, MA
Participating in a rotational leadership program, working closely with Senior VPs and Directors in key functional groups to gain a comprehensive understanding of Emerging Markets function and operation and prepare for the design and execution of new product launches in targeted markets. - Global Medical Affairs: Gained a thorough understanding of GMA functions and proposed a Global MA Strategy Plan for a new product by defining launch execution plan objectives and strategies - R&D (Clinical Development & Regulatory): 1. Provided a comprehensive feasibility assessment for conducting a phase 3 clinical trials in China for a given pipeline product by aiding in the proactive understanding of the competitive landscape in China 2. Gained a systematic view of imported drug registration process and strategies for both chemical drugs and biologics in China - Market Access: Developed professional strength in understanding strategic and tactical pricing, health technology assessment, and reimbursement strategies for emerging markets - Global Commercial Strategy and US Commercial: 1. Developed and presented a brand strategy plan for a given product being planned to launch in China by leveraging global brand planning process, incorporating market research findings and calling out key data gaps, implications to the Chinese market and high level differences 2. Proposed and presented a new product messaging plan after engaging in a market research project on product's messaging, directly hearing from the voice of physicians to learn their concerns and motivations, and identifying the gaps and practical actions to address the issues 3. Conducted a market research of the competitive landscape for a certain therapeutic area in China to facilitate the launch 4. Participated in sales training/field rides/etc

MBA Marketing Intern, CNS/Invega Team
Beijing, China
* Aided the refinement of 2012 business plan by further differentiating Invega on the Schizophrenia marketplace to achieve 1bn RMB sales in 2012 * Implemented two signature campaigns involving 50 hospitals in 20 cities to enhance the awareness of Invega's unique value proposition and facilitate physicians' evaluation on fucntionality during daily practice

Health Techonology MBA Summer Consultant--Geneva, Switzerland
Geneva, Switzerland
* Steered strategic analysis of all WHO guidelines on various topics and determined key development areas for global/national/regional health technology standards and services * Developed designing framework for ‘Essential Medical Device’ website that enables underdeveloped nations with limited resources to budget, procure and implement health facilities

MBA Intern
Raleigh-Durham, North Carolina Area
* Performed market research to analyze global CRO's matrix and identify potential partners in Asian countries, especially in China; * Conducted market analysis to identify thought leaders and strategic consultants who believe in adaptive approach in drug development in order to communicate the value proposition of Health Decisions.

Postdoctoral Researcher
University of Dundee, Ninewells Hospital
* Received a UK patent (2010) for the identification of Simvastatin as a potential drug to treat a rare skin disease, this work resulted in a clinical trial in Canada and allowed the project a big step forward towards the treatment of PC; * Worked in Prof. Irwin McLean's lab and served as one of the key contributors for identifying the filaggrin gene as the cause of the common dry skin condition ichthyosis vulgaris, and further showing that these mutations, carried by more than 10% humans, are the major genetic predisposing factor for atopic dermatitis and associated allergic conditions; * First-authored three articles in top journals, including Nature Genetics; * Co-authored more than 15 articles in peer-reviewed journals

Dermatology and Human Genetics Department
Peking Union Medical College Hospital
* Identified a novel mutation contributing to the occurrence of Type II PC, a rare skin disease. * Holder of Clinical Medicine License granted by Chinese Ministry of Health in 2004
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