Heather Kelly
Berkeley,CA
Summary
Seasoned leader in drug development and global health initiatives, adept in team management and organizational development. At Vir Biotech, spearheaded a high-impact innovation fund, leveraging skills in organizational development, SmartSheet and stakeholder relations to drive strategic decisions across a diverse portfolio. Demonstrated excellence in aligning cross-functional teams and executing complex projects, expanding access to new and established essential medicines worldwide.
Overview
20
20
years of professional experience
Work History
Senior Director, Research Program Management
Vir Biotech
San Francisco, CA
07.2021 - Current
- Lead the project and program management team in infectious disease and oncology through early discovery and research.
- Align the research leadership team, representing different disciplines, around new projects, partnerships, adjustments, and activities.
- Create a research-focused program management team; hired and supervised a high-performing team of project managers to support a wide-ranging portfolio.
- Provide project management support and training to project team leaders and managers throughout the research organization (15 projects, 200 scientists).
- Design and launch a special innovation fund with 10% of the research budget (~$65M) to support special breakthrough projects.
- Work with research leadership to establish a regular, formal project review structure to enable strategic portfolio and resourcing decisions.
Drug Innovation and Access Team Leader
PATH
San Francisco, CA
01.2018 - 01.2020
- Manage a portfolio of infectious disease therapeutic candidates across the development pipeline, from discovery to scale-up, globally.
- Lead a team of nine pre-clinical and clinical scientists, clinical operations, project managers, and communications specialists through a critical transition period.
- Align external partners, donors, and stakeholders around new projects, development plans, contracts, licensing agreements, and commercialization plans for new products.
- Design and implement an inclusive, analytical portfolio assessment process to drive critical program and labor decisions.
- Identify and design new projects across therapeutic areas, and across the development timeline, within various geographic regions.
- Develop, design, and manage the global Access to Essential Medicines Initiative, assessing access and uptake of 460 medicines on the WHO Essential Medicines List.
Deputy Director, Portfolio and Project Management
PATH
San Francisco, CA
01.2017 - 01.2020
- Lead the drug development group's project management team.
- Establish a formal project management structure and tools across projects.
- Align technical and support teams, including pre-clinical, CMC, clinical, access, regulatory, communications, compliance, and legal teams at PATH and external partners.
- Provide senior-level project management and strategic leadership for drug development and access projects.
Senior Program Officer
PATH
San Francisco, CA
01.2012 - 12.2017
- Lead the PATH team in a Phase 2B clinical study of a biomedical HIV pre-exposure prophylaxis long-acting injectable.
- Managed partners and stakeholder communications with the manufacturer, donors, scientists, FDA, and operational partner (NIH/DAIDS) in the design and implementation of the clinical study in the US, South Africa, and Zimbabwe.
- Coordinated ethics committee submissions; developed safety reporting structure for the study.
- Led a successful proposal for a comprehensive diarrheal disease portfolio grant from a European bilateral funder ($10M).
Associate Director, Access
Institute for OneWorld Health
San Francisco, CA
01.2005 - 12.2012
- Designed and implemented Access, Phase 3, and Phase 4 clinical studies for the medical treatment of visceral leishmaniasis in rural India, Nepal, and Bangladesh.
- Project team leader for Phase 3B clinical study in Bangladesh for Paromomycin IM Injection.
- Managed site selection, readiness, and training for all sites across the three countries.
- Developed regulatory strategy and managed timelines, budgets, relationships with partners, CROs, vendors, regulatory consultants to facilitate registration of new therapy in Nepal
Education
MASTER of PUBLIC ADMINISTRATION - Economic And Political Development
COLUMBIA UNIVERSITY
New York, NY01.2002
BA - ENGLISH LITERATURE
COLLEGE OF WILLIAM & MARY
Williamsburg, VA01.1995
Skills
- SmartSheet
- SharePoint
- Tableau
- Microsoft Office Suite
- Stakeholder relations
- Team management
- Organizational development
Publications and Presentations
- Social and Cultural Factors in Neglected Tropical Diseases, 2015-2025, Seminars presented at University of Santa Cruz Department of Molecular, Cell, and Developmental Biology class on Neglected Tropical Diseases, Santa Cruz, California
- Workshop and abstract reviewer, annually 2020-2025, International AIDS Conference
- Effectiveness Study of Paromomycin IM Injection (PMIM) for the Treatment of Visceral Leishmaniasis (VL) in Bangladesh, Jamil, K.M., Haque, R., Rahman, R., Faiz, M. A., Abu Toha Md. Rezwanul Haque Bhuiyan, Kumar, A., Kelly, H., Ghosh, R. S., 01/01/15, PLoS Negl Trop Dis PLOS Neglected Tropical Diseases, 9(10), 10.1371/journal.pntd.0004118
- Ethical Concerns in the Globalization of Clinical Trials, April 2012, Lecture presented at World Vaccine Congress, Washington, DC
- Integrating a Clinical Trial and a Public Health Initiative: Data Collection Challenges and Solutions, June 2010, Lecture presented at Global Health Council Annual Conference, Washington, DC
- Data Collection Challenges in an Integrated Clinical Trial and Public Health Program, April 2010, Oral presentation at Unite for Sight, New Haven, Connecticut
- Integrating a Clinical Trial and a Public Health Initiative: Opportunities and Challenges, Nov 2009, Poster at American Society of Tropical Medicine and Hygiene, Washington, DC
Other Activities and Experience
- US Peace Corps, Papua New Guinea, 1998-2000, Secondary School Teacher at remote island government school
- United Nations Dev Programme, New York, 2002, Consultant to the Human Dev Report Office
- Family Care International, New York and Dar es Salaam, Tanzania, 2002-2005, Anglophone Africa Proj Manager
- Hobbies include backcountry hiking, scuba, knitting, snowshoeing/snow camping
Timeline
Senior Director, Research Program Management
Vir Biotech
07.2021 - Current
Drug Innovation and Access Team Leader
PATH
01.2018 - 01.2020
Deputy Director, Portfolio and Project Management
PATH
01.2017 - 01.2020
Senior Program Officer
PATH
01.2012 - 12.2017
Associate Director, Access
Institute for OneWorld Health
01.2005 - 12.2012
MASTER of PUBLIC ADMINISTRATION - Economic And Political Development
COLUMBIA UNIVERSITY
BA - ENGLISH LITERATURE
COLLEGE OF WILLIAM & MARY
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