Yan Yan L Starkey, MD, MBA, MSc.

104 S Powder Mill Road, Morris Plains, NJ 07950

201-650-9340(cell); Email: listarkey@aol.com
SUMMARY OF EXPERIENCE
Sixteen years of experience in medical and clinical research areas for both OTC
and Rx drugs covering all phases I to IV for global clinical trials. As a Medica
l Director in the central global team I support commercial teams by providing me
dical and scientific expertise to drive optimal business strategies and tactical
business activities. I provide medical input into Promotional Advertising Revie
w Committee for all promotional and external materials. I organize presentations
and workshops for KOLs and I maintain the department?s network of contacts with
key physician leaders. As a medical team leader I am responsible for developing
and managing two medical scientists as direct reports. I am responsible for pro
viding the scientific and medical expertise required for conception, high qualit
y design, execution, analysis, and reporting of clinical research in many global
clinical programs. I have four years project management experience in a top CRO
company. In addition I have extensive international regulatory and medical expe
rience to support global R&D development in BRIC emerging areas such as Indian a
nd China. Recently I have written a chapter ?China?s Regulated Pharmaceutical Ma
rket? in the book ?Principles and Practice of Pharmaceutical Medicine? published
by Wiley. Additionally I have six years of experience practicing as a Pediatric
ian and three years of postdoctoral research in Infantile Malnutrition and Brain
Development. Therapeutic areas: Analgesics, topical products, RT, CNS, infectio
us disease, GI and Women healthcare etc.
EXPERIENCE
Medical Director, Medical Affairs, GSK Consumer Healthcare, NJ 2007 Jan-present
In this role I am a key medical person in the global central team to supervise t
wo principle medical and one claim scientists as direct reports in providing med
ical/clinical advice for all aspects of the R&D and the commercial group?s activ
ities related to analgesic products. I participated extensively in claims review
and adverting development and I prepare materials for KOL activities and confer
ences. I work cross functionally to manage extensive clinical programs covering
a variety of clinical areas related to pain management such as headache, cough/c
old, osteoarthritis, and back pain with both oral and topical products. I am a k
ey medical leader for a topical wound healing product development with our Inter
national Venture team. This includes from Phase 1 PK to multi-center global phas
e III/IV trials. I work to ensure that medical/clinical activities are aligned t
o medical, regulatory, legal and commercial interests.
? Works closely with the marketing team to provide medical strategic input to ma
rketing activities, and to develop lifecycle management and brand strategies
? Participates in advertising and promotional copy material development and revi
ew
? A member of GSK Medicines for Children Advisory Network (MCAN) and CHPA
? Manages global communication plan to support global product launch activities
? Develops KOLs, arranges advisory board workshops and manages investigator init
iated studies
? Presents data and medical views to marketing, R&D, senior management, scientif
ic symposiums and advisory board meetings
? A leader of the medical team covering all aspects including clinical developme
nt plan, protocol development, monitoring trials, and report generation
? Represents the company on medical issues to respond to FDA, EMEA, MHRA, TGA et
c and many markets? media challenges
? Leads the clinical team to prepare clinical sections of global regulatory subm
issions
? Oversee phase I units and CROs to conduct clinical trials to meet budget, qual
ity and timeline
? Interact with the China GSK team for emerging market pipeline development. Pro
vides medical strategic input and participate in product in-licensing review
Clinical Project Director (Clinical Consultant), The Medicine Company, NJ
2006-07
I served as a