Vice President, Vaccines Business Strategy Lead, PPD 

As Regional Medical Officer in PPD Biotech covering Europe and Israel, I provide therapeutic expertise and strategic guidance to clients and offer over 13 years of clinical research experience.

Executive Director and Regional Medical Officer, Europe and Israel 

Medical Director

Medical Monitoring for Phase 1 studies and Vaccine trials. Responsibilities include medical management of Serious Adverse Event (SAEs) reports, and medical oversight of clinical trials to ensure compliance with company Standard Operating Procedures (SOPs), sponsor directives, and regulatory requirements. SMC material preparation and presentation.

Associate Medical Director

NIH, Office of the Director, Office of AIDS Research

FEBRUARY 2016- PRESENT   NIH Office of the Director, Office of AIDS Research 
DIRECTOR, THERAPEUTICS RESEARCH

•	Oversee a research portfolio of > $800 million USD 
•	Prioritize key research in HIV Pre-Exposure Prophylaxis, Therapeutics and Prevention of Mother to Child Transmission for funding with AIDS dollars
•	Chair the Therapeutics Coordinating Committee in development of the Trans-NIH Plan for HIV-Related Research http://www.oar.nih.gov/strategicplan/fy2016/pdf/FY-2016-Trans-NIH-Plan-for-HIV-Related-Research.pdf
•	Directly supervise staff in support of these activities

Director, Therapeutics Research

July 2007 - PRESENT  NIH/NIAID/Division of AIDS - Prevention Science Program/ Clinical Prevention Research Branch  DEPUTY BRANCH CHIEF (2011-present)
Promoted to Deputy Branch Chief, Clinical Prevention Research Branch in the Prevention Sciences Program at the Division of AIDS/ NIAID/NIH (DAIDS) in 2011
●	Successfully developed Funding Announcements
○	Methods for Prevention Packages Program (R01) PAR
○	Innovative Measures of Oral Medication Adherence for HIV Treatment and Prevention (R01)
●	Organize Scientific Meetings 
○	Technical Convening on Clinical Trial Design Issues for Multipurpose Prevention Technologies (MPTs) (planned for 2015)
○	Workshop on Quantitative Methods to Advance Combination Biomedical HIV Prevention Research (2011)
Advance biomedical prevention products (injectable PrEP agents, Truvada, ART as Prevention) through clinical testing (Pre-Phase I and Phase I-III) with HIV Prevention Trials Network (HPTN) investigators.

Highlighted Studies 
Clinical development and medical monitor for the following studies. Full list available upon request: 

●HPTN 052- A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy plus HIV Primary Care versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 In Serodiscordant Couples (Phase III IND study)
● Science Magazine Breakthrough of the Year, 2011
●HPTN 083 - A Phase 2b/3 Double Blind Efficacy Study Of Quarterly Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (Truvada), For Pre-Exposure Prophylaxis in HIV-Uninfected Men and Transgender Women who have Sex With Men (Phase III IND study)
●	HPTN 076 Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278 LA, for Pre-Exposure Prophylaxis (PrEP) (Phase II IND study)
●	HPTN 077 A Phase IIa Study to Evaluate the Safety and Pharmacokinetics of the Investigational Injectable HIV Integrase Inhibitor, GSK1265744, in HIV-Uninfected Men and Women (Phase II IND study)

Deputy Branch Chief, Medical Officer

The Henry M. Jackson Foundation for the Advancement of Military Medicine

●	Served as a Division of AIDS/NIAID contract Medical Officer for clinical trial protocols within the HPTN as well as non-Network R01 studies. 
●	Performed a Division of AIDS-wide qualitative evaluation of the Comprehensive International Program for Research on AIDS (CIPRA) grant mechanism. 
o	Developed and validated interview questionnaires
o	Administered and coded over 100 qualitative interviews
o	Prepared a final written report detailing the findings 
o	NIH Superior Performance Award received for the successful completion of this evaluation

Medical Officer

PAHO/WHO

●	Collaborated with a multidisciplinary team of clinicians, epidemiologists, statisticians and public health staff from the Guatemalan Ministry of Health and the Pan American Health Organization to establish a hospital-based surveillance system for Rotaviral illness in three Guatemala City hospitals.
●	Developed the surveillance protocol, manual of operations, case report forms, staff training workshops, and budgets for this project along with Guatemalan colleagues.

Short Term Consultant

I am a physician executive board certified in Preventive Medicine and Public Heal with over 18 years of increasing responsibility leading strategy development and implementation for the global Vaccines business at PPD, clinical development (Phase I-IV) and medical oversight for multiple domestic and international vaccine and HIV treatment and prevention clinical trial programs. I have experience in the CRO, government (NIH/NIAID/ DAIDS), normative body (PAHO EPI) and non-profit settings and in global business development and alliance management. I have led teams in a matrixed and direct report structure and been an active participant and program committee member of the Boston Biotechnology Summit since 2017 helping connect European and Boston-based companies. I am fluent in French, Spanish and Hebrew.

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