• Managed a client portfolio consisting of over 150 physicians in efforts to promote three cardiovascular lipid lowering products (Trilipix, Niaspan, Simcor)
• Collaborated with four team members strategically targeting high volume cholesterol primary care physicians in the San Francisco territory
• Successfully launched Trilipix, a fibrate for dyslipidemia, targeting key physicians and achieved 80% penetration of top decile prescribers   
• Total performance to date is 97.3% of sales goal, exceeding both nation and region; Trilipix  and Niaspan  performance above both nation and region
• Winner of Spiff and “Reward It” bonuses for achieving sales goals

Highly experienced Regulatory Affairs Specialist with a 6 year record of providing results for employers and clients.  I have a RAC certification from the Regulatory Affairs Professional Society demonstrating my expertise.  The services I can render include:

• Knowledge and competence in regulations and good practices governing clinical trials and new pharmaceutical products
• Assemble, organize and submit applications to the FDA for new drug products
• Advise clients regarding regulations and standards for clinical trials
• Reputation for honesty, reliability, and fostering good relationships

• Ten years of experience in early and late stages of therapeutics development
• Strong knowledge in multiple therapeutic areas including metabolic diseases, oncology and infectious diseases
• Excellent business management and leadership skills
• Managed teams including internal direct reports, external consultants, contract labs and academic collaborators
• Led complex projects from start-up, implementation and completion within timeline and budget
• Presented and chaired at international scientific meetings
• Excellent communication skills in both English and Mandarin

• Specialized in discovery and clinical research /development of novel cancer therapeutics.
• Strong expertise in translational medicine bridging discovery and developments of therapeutics, and managed the interface between research and clinical development.
• Over 10 years of post-doctoral managing and recruiting experience to build and expand research teams with hiring Ph.D., M.D., M.S. and B.S. levels of scientists and lab managers.
• Highly skilled at applying immunology, cell biology, microbiology and molecular biology background in discovery, development and clinical analysis of cancer therapeutics.
• Established and managed research activities in tumor immunology and discovery of biomarkers, which were translated into pre-clinical validation and clinical development.
• Skilled at epitope prediction for development of new cancer therapeutics and experienced in identification of potential cancer targets.
• Provided scientific leadership in research and clinical development of therapeutics.
• Coordinated clinical trials support activities for early therapeutics development (Phase I/II).
• Well versed in developing immunotherapeutics in oncology/hematology, establishing clinical monitoring strategies, supporting late stage (Phase III) of clinical development, measuring disease-specific immune responses in patients and directing bioassay development activities.
• Skilled at design and validation of biomarkers, immuno-stimulatory antibodies and immunogenicity studies, and implementation of them in clinical analysis.
• Experienced working with regulatory agencies and in identification and management of contract research organization (CRO) alliances.
• Accomplished close collaborations formed through networks to industry and academic entities to implement new initiatives based on a comprehensive background in science.
• Experienced in strategic plans and implementation of biotechnology initiatives to a start-up company, and managed scientific and technological evaluation of in-licensing opportunities.
• Facilitated cross-functional activities (research, development, clinical, finance, legal, commercial) and operational planning, delivered project goals, led due diligence, managed team operations, and communicated updates to upper management team.
• Identified and evaluated new cutting-edge technologies, skilled at strategy development and integration of development plans, and demonstrated international experiences.
• Led multidisciplinary teams, acted as primary contact to extramural partners, accommodated issue resolution, and assured correct and timely information flow to stakeholders.
• Directed and oversaw experiments following Standard Operating Procedures (SOP) and using Good Laboratory Practice under Biosafety Level 2 and Level 3 conditions.

• Worked on the European Medical Device Directive as it applies to Clinical data and reports
• Conducted literature reviews to determine the most recent, relevant clinical data regarding advice or device family
• Reviewed existing technical files and identify areas that do not meet the most recent standard
• Updated and developed Device Technical files to meet the most recent standard specifically the European Medical Device Regulations
• Authored clinical reports and documents used in regulatory submissions.
• Assured timely accurate and complete collection of data from the literature searches and or study data
• Interacted with various customers (internal and external) in order to facilitate and complete regulatory submissions
• Handled multiple projects
• Performed other related duties as assigned