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Affaires médicales
Catégorie :

Divers

Date de dernière mise à jour :

25 juillet 2014

Lieu :

France

CV :

Profile
Ph.D. medical affairs manager with clinical HIV, inflammation/oncology experience and over ten years in the biopharmaceutical industry of field based medical science liaison and clinical development activities. Well developed relationship building and networking skills. Experience includes identifying, recruiting and managing Key Opinion Leaders (KOLs), clinical trial management, championing research initiatives, speaker training, publication planning, KOL relationship development, presenting clinical information to medical and scientific groups, sales force training, scientific writing, cross functional team management, business development and marketing.

Therapeutic/ Clinical Development Expertise
• HIV • Dermatology • • Neuroscience
• Fungal Infections • Movement Disorders • • Pain Management
• Oncology • Neurology • • Urology

Professional Highlights
• Developed and conducted presentations with KOLs, clinical investigators and providers in the United States and Europe.
• Identified and trained KOL speakers for national and international scientific conferences.
• Developed relationships with regional and international KOLs at major teaching institutions in the areas of HIV, Dermatology and Pain Management.
• Strong networking abilities with a national and international network of physician relations in different therapeutic areas.
• Managed HIV clinical trials – four successful drug approvals in four years: Viread, Emtriva, Truvada and Atripla.
• Championed clinical research initiatives through the organization by managing cross functional R&D, medical scientists and commercial teams.
• Marketing and business development experience – Gilead Sciences for Truvada in Europe and other major pharmaceutical and biotechnology companies.
• Pre-Doctoral Intramural Research Training Award Fellowship at the National Institute of Health in magnetic resonance imaging technology for Renal Disease.
• Post Doctoral research at the University of California San Francisco in clinical medical imaging for oncology and neurology.
• Winner of the Kellogg Biotech Business Case Competition – Phase III Parkinson Disease Clinical Trial Design.

Experience
GILEAD SCIENCES, INC., Foster City, CA 2012 - Present
HIV Medical Affairs Project Manager
$10.8 billion global biopharmaceutical company specializing in the development of innovative therapeutics in areas of unmet medical need.

Led the HIV medical affairs phase IV investigator initiated program.
• Built relations with regional and international KOL physicians participating in the Phase IV program.
• Identified and developed clinical investigators for research consistent with medical affairs strategies.
• Collaborated cross-functionally with clinical research, regulatory affairs, drug safety, marketing and other internal key stakeholders for the review, approval and implementation of investigator-initiated clinical trials, including protocol review, data analysis and publication planning.
• Presented and developed scientific clinical/medical presentations for medical education to MSLs, KOLs at medical conferences and in-house personnel including sales force representatives.
• Provided medical expertise to investigators and Gilead personnel in the development, submission and presentation of Phase III abstracts, manuscripts and data disclosures.

MYOSCIENCE INC., Redwood City, CA 2011 - 2012
Medical Science Liaison/ Medical Affairs Manager
Medical device start up company with a focus on dermatology, pain management and movement disorders.

Provided medical affairs field training and built relationships with Key Opinion Leaders.
• Developed strategically aligned promotional materials in partnership with marketing for physicians and patients in the United States and Europe.
• Identified and coordinated with investigators and sites in dermatology for company sponsored clinical trials and in pain for Investigator Initiated Trials to implement myoscience’s clinical strategy.
• Built strong relations with KOLs in private practice resulting in a multi-center Phase III clinical trial with sites in France, Germany and Italy for Aesthetic Dermatology.
• Networked and coordinated with physicians in California and other states to develop IICTs for pain associated with osteoarthritis and peripheral neuropathy.
• Identified and coached physician speakers for national and international presentations. Led to exceeding the strategy goal for the number of clinical presentations at scientific meetings.

STIEFEL LABORATORIES, a GlaxoSmithKline Company, Palo Alto, CA 2007 - 2011
Senior Portfolio Manager
$1 billion in revenue international specialty pharmaceutical company specialized in dermatology.

Managed strategic decision making for pipeline compounds and marketed products.
• Created 30% of new indications and product line extensions through scientific exchange with KOLs and internal teams for psoriasis, acne, fungal and aesthetic indications.
• Managed cross functional scientific teams across multiple geographies to develop clinical strategy presentations for quarterly board of directors meetings which led to increased alignment on product life cycle management.
• Facilitated the decision making process on dermatology drug compound development and regulatory pathway. Led to $25 million in cost savings. Allowed the company to stay within the strategic planned budget.

BURRILL & COMPANY, San Francisco, CA 2006 - 2007
Senior Venture Associate
Life Sciences merchant bank and Venture Capital firm with $850 million under management.

Researched, identified, and evaluated potential investments for a $211 million private equity fund, primarily in Biopharmaceuticals.
• Identified partnering opportunities for portfolio companies by interpreting scientific data and analyzing the competitive landscape across therapeutic areas including inflammation and oncology.
• Provided senior management teams with recommendations on compound development pathway, clinical trial design, product positioning and sales strategies.

GILEAD SCIENCES, INC., Foster City, CA 2002 - 2006
Senior Clinical Analyst
$10.8 billion global biopharmaceutical company specializing in the development of innovative therapeutics in areas of unmet medical need.

Supported clinical trials and assisted in European commercial strategy launch.
• Conducted clinical data analysis and adverse event reporting according to ICH, GCP and federal regulatory guidelines for Ambisome and the HIV pipeline. Led to the approval of Gilead’s HIV franchise – five successful drug approvals in four years: Viread, Emtriva, Truvada and Atripla, which represented $2.13 billion in sales for 2006.
• Created a long-term strategic marketing plan for the launch of Truvada in Europe. Global sales of Truvada reached $3.1 billion in 2013.
• Negotiated and managed agreements with contract research organizations, generating 15% in cost savings.

ALZA CORPORATION (JOHNSON & JOHNSON) Mountain View, CA 2000 - 2001
Clinical Data Analyst
Leader in pharmaceutical drug delivery solutions, primarily transdermal and osmotic delivery.

• Performed clinical data analysis according to study protocol and SOPs for Phase IV post-marketing of Concerta. Analyzed post marketing Phase IV data for Ditropan XL, a multi-million dollar drug for overactive bladder drug.
• Developed data analysis procedures which shortened timeline deliverables.

Education
MBA, University of California, Berkeley, Haas School of Business (2007)
Postdoctoral Fellow, University of California San Francisco, Neuroscience & Oncology
Ph.D., Biophysics, The Catholic University of America (1997)
BS, Physics and Mathematics with Honors, The Catholic University of America (1990)

Additional
Medical Science Liaison Society
Board of the Healthcare Business Women’s Association of San Francisco
Winner of the Kellogg Biotechnology Business Case Competition – Clinical Trials Design (2007)
Values at Work Award, Gilead Sciences Inc. (2005, 2006 and 2013)
Languages: English and French (native)
Authored and Co-authored several Publications

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