Experience

Curevo Vaccine
• United States
• Biotechnology Research
• 1 - 100 Employee
• Associate Director Clinical Operations

  • Apr 2023 - Present


Medicago

• Canada
• Biotechnology Research
• 200 - 300 Employee

• Principal Manager Clinical Studies

  • Oct 2021 - Apr 2023

  * Principal project team lead for COVID vaccine clinical development program; * Lead clinical operations strategic planning, start-up and execution of multiple COVID vaccine clinical trials, including a global pediatric COVID vaccine development program; * Provide clinical operations expertise in study design, protocol and ICF development, IRT and data management systems planning, set up, execution; * Vendor oversight and management, including contracting, budget, deliverables; * Accountable for timeline development, deliverables, management and oversight of multiple functional area inputs. Show less



PATH

• United Kingdom
• Design
• 1 - 100 Employee

• Senior Clinical Research Officer

  • Mar 2014 - Aug 2021

  Provided clinical operations leadership and expertise to numerous programs at PATH’s Center for Vaccine Innovation and Access (CVIA), including pediatric and maternal clinical trails for Pertussis and RSV vaccines, ppRTS,S Malaria vaccine, PCV10 and whole cell pneumococcal vaccines, nOPV2 polio vaccines, and to the WHO Malaria Vaccine Implementation Programme and the BARDA Influenza vaccine development programs, and to our funders and partners to advance global clinical development in low and middle resource countries. Led and facilitated a wide range of clinical trial planning and implementation activities, from concept through close out, including vendor management and oversight, identifying and evaluating investigators and trial countries and sites, assessing operational capacity, identifying training and equipment needs, developing in-country regulatory and risk-mitigation strategies, contributing to protocol design and development, drafting clinical trial related documents, facilitating contract negotiations, budget development, and timelines with CROs and other partners. Oversaw operational activities to ensure clinical trials adhere to ICH, GCP, FDA and equivalent international regulations. Show less



Fred Hutchinson Cancer Research Center, HIV Vaccine Trials Network

• Clinical Trials Manager, Vaccine and Infectious Disease Division

  • May 2006 - Feb 2014

  HVTN Leadership Operations Center. Managed, oversaw, and coordinated planning, implementation and day-to-day operations of numerous Phase I – Phase III HIV vaccine clinical trials at 28 clinical sites (11 US domestic; 17 international (Southern Africa, South America, Caribbean, Europe), including numerous ancillary, mucosal, and observational studies in populations at low and high risk of HIV infection. Managed, oversaw, facilitated efficient study implementation through complex coordination between multi-disciplinary groups: Investigators, clinical site staff, in-country National Health Ministries, regulatory agencies and institutions, academic partners, NIH/DAIDS, vaccine developers, HVTN lab program, DAIDS Pharmaceuticals Affairs Branch, Statistical Data Center, other networks (CDC, IAVI, US Military). Project manage regulatory planning, budget development, contract negotiations, timelines, and expectations. Monitor, evaluate study progress, including recruitment, enrollment, retention, clinical site performance. Oversee clinical site development, conduct site visits, assessments, evaluations, training. Author study-specific documents and training materials, assist in drafting manuscripts, posters, and presentations. Creatively problem solve wherever needed. Show less



Yale University School of Medicine

• United States
• Research Services
• 700 & Above Employee

• Assistant Director, Center for Interdisciplinary Research on AIDS (CIRA)

  • 2004 - 2006

  Oversaw, managed day-to-day operations of CIRA's Office for International Training (OIT), which provided programmatic and administrative support to numerous international HIV/AIDS,TB prevention research and clinical training projects in Russia, China, India, Nicaragua, and Sub-Saharan Africa. OIT also supported research projects in high-risk and vulnerable populations, structural, community-level interventions, integration of HIV treatment, prevention, as well as the Monitoring & Evaluation Unit operations for the Bristol-Myers Squibb Secure the Future Initiative. As Assistant Director, directed, coordinated, and administered OIT operations, provided technical support and administrative oversight of staff for projects. Liaison to Yale, NIH, foundations and international partners. Provided strategic planning, research support to CIRA Director, wrote grant proposals, presentations, manuscripts, attended conferences, and helped teach an HIV/AIDS policy course at Yale College. Show less



Center for Minority Health, University of Pittsburgh School of Public Health

• Research Fellow

  • Aug 2003 - Aug 2004

  HIV/AIDS Prevention Research Core: Assisted Senior Faculty in the development and implementation of research designed to increase access to HIV primary and secondary prevention interventions for at-risk communities of color. Health Disparities Research Training Core: Assisted Senior Faculty in the development of a university-wide health disparities research training program with a special focus on Community Based Participatory Research (CBPR). HIV/AIDS Prevention Research Core: Assisted Senior Faculty in the development and implementation of research designed to increase access to HIV primary and secondary prevention interventions for at-risk communities of color. Health Disparities Research Training Core: Assisted Senior Faculty in the development of a university-wide health disparities research training program with a special focus on Community Based Participatory Research (CBPR).



Center for Health Equity Research, VA Medical Center, University of Pittsburgh School of Medicine

• Project Coordinator - Veterans Aging Cohort Study (VACS)

  • Jan 2002 - Jul 2003

  Managed day-to-day operations of nationwide, 8-site prospective cohort study of Veterans with HIV/AIDS (n=6000). Oversaw enrollment of 6000 patients. Assisted in the design, coordination, and implementation of numerous sub studies, including blood sampling/banking, neuro-psychiatric testing, telephone interviews, qualitative focus groups. Conducted site visits, assessments, and training. Monitored and evaluated study performance. Led the development of a database tracking system. Oversaw data collection and analyses. Wrote grants, reports, correspondence, manuscripts, IRB materials. Liaised with NIH, universities, VHA, scientific consultants. Show less



International Rescue Committee

• United States
• Non-profit Organization Management
• 1 - 100 Employee

• Field Coordinator / Information Officer / Grant Writer

  • Jan 2000 - Dec 2001

  IRC Kosovo/Macedonia, Pristina, Kosovo, Yugoslavia: Managed field operations for emergency shelter program, serving Albanian, Serbian, and Romany communities. Coordinated communications for IRC humanitarian aid programs, working with UN Mission, NATO, local & international media, donors. Wrote numerous grant proposals to UNHCR, USAID, DFID, EU. IRC Croatia, Zagreb, Croatia: Developed program, wrote $6 million USAID grant proposal in support of refugee resettlement. IRC Georgia, Tbilisi, Georgia: Developed program, wrote vocational training grant proposal for orphans in break-away region of South Ossetia. Show less