Lisa Anderson Email & Phone Number

United States

Program management for global product development drug development teams, focused on clinical development, regulatory submissions, commercial preparedness, and integrated project planning.

South San Francisco, California, Us

• Program manager across three clinical assets in early-, mid-, and late-stage development. Partnered heavily with regulatory, clinical, and cross-functional leads and teams to advance products through strategic regulatory engagements, milestones, and approvals, for both pediatric and adult populations. Achieved orphan drug and rare pediatric disease designations for multiple assets. • Strategically devised and managed functionally integrated project plan and timeline for sNDA filing. Led and managed cross-functional working groups and sub-teams for rapid decision making. Attended 3 FDA meetings. • Prepared teams ahead of global label expansions and regulatory meetings; aligned on messaging, timing, and risks.• Managed global regulatory sub-team meetings and alignment within teams and with stakeholders of key upcoming engagements and deliverables, ensuing priority items are discussed and next steps defined to keep momentum and ensure alignment. • Managed cross-functional working groups and sub-teams for rapid assessment and decision making, acted as a point of contact for issues occurring in programs, and collaborated to build consensus, clarity, and an actionable path forward. GBT is a global biopharmaceutical company dedicated to the discovery, development, and delivery of life-changing treatments that provide hope to underserved patient communities, focusing on rare hematology, starting with sickle cell disease (SCD). SCD is a lifelong, devastating inherited blood disorder impacting millions of people worldwide, predominantly in populations of African, Middle Eastern, and South Asian descent.

New York, New York, Us

Bothell, Washington, Us

• Led complex cross-functional global teams in submission of late-stage supplemental Biologics License Application and global Market Authorization Applications (MAA) across 7 countries concurrently, in collaboration with product and functional leadership and alliance partner. Achieved approval by FDA and EMA. Executed deliverables and corporate goals, built communications and sequester plan, and spearheaded Health Authority response process. • Built and managed functionally integrated submission timeline and dashboard. Reported filing progress weekly to senior leadership. Managed recurrent team, sub-team, and partner meetings; ensured rapid risk resolution. • Supported product launch and global commercial organization for interdependent scenario planning and timing. • Coordinated and prepared teams for Health Authority interactions pre- and post-submission, including Agency meetings and timely response to Information Requests from multiple Health Authorities concurrently.Seagen is a biotech company focused on developing monoclonal antibody-based therapies for the treatment of cancer.

• Strategically managed complex malaria research financial portfolio of ~$14M across 12 grants plus embedded sub-contracts and 22-member lab through merger and acquisition activities. Led portfolio relinquishment activities and forecasted financial projections for research activities, animal studies, and clinical trial. [Acquired] CIDR's is the largest independent, non-profit organization in the United States focused solely on infectious disease discovery research, and works to end preventable deaths caused by malaria and other infectious diseases that disproportionately affect the world’s poorest by making transformative scientific advancements that lead to the treatment of infectious diseases.

Seattle, Wa, Us

• Led end-to-end project management and implementation of enterprise patient-centric projects to improve business capabilities and offerings. Built PMO structure and led continuous process improvement culture.• Aligned strategy and execution teams for succinct project execution. Facilitated trade-offs between strategic choices, resolved issues, implemented project escalation process, and monitored and controlled projects.

Seattle, Wa, Us

• Coordinated complex biomedical portfolio including pre-clinical through Phase 3 biological candidates and international Phase 3 clinical trial regulatory, operational, and administrative coordination. Worked with cross-functional and global teams and partners to achieve project deliverables. Monitored vaccine candidate progress through project milestones, stage-gates, and licensure. Coordinated with regulatory bodies, IRBs, and CROs and supported development of trial protocols, clinical trial agreements, and investigator’s brochure. Supported coordination of IND and pre-IND meetings, GMP facility audits, large partner and donor meetings and collaborations, and timely submission of project documents. Facilitated strategy development for establishment and project structuring of new product portfolio.• Coordinated development of proposals and project timelines, milestones, and action items. Managed elements within the product development work stream (mainly of polio, rotavirus, and developing-country vaccine manufacturer projects), achieving vaccine development awards of $30,000,000, keeping project team members informed of progress, changes, and issues impacting deliverable progress and timelines. Streamlined proposal and project development among scientific and administrative staff. Built production schedules, prioritized requirements, and monitored status, driving progress towards key deliverables, ensuring all were on time and within scope. • Streamlined partner and sub-ordinate agreement management; accelerated financial tracking, progress report, and financial reporting tool for management of project partners, monitoring of project progress, and for overall donor reporting. PATH is an international, nonprofit global health organization whose mission is to improve the health of people around the world by advancing technologies, strengthening systems, and encouraging healthy behaviors.

Seattle, Wa, Us

• Coordinated clinical trial deliverables and teams; facilitated internal and external engagement. Developed project agendas, minutes, and action items for teams.• Managed contracts and related progress and financial reporting for clinical trial contractors, sub-contractors and consultants. Coordinated with procurement and legal for master service agreements and purchase orders. • Managed publication planning and prepared scientific papers for publication in academic journals (Human Vaccines & Immunotherapeutics; The Lancet; Vaccine). Conformed raw drafts to journal publication standards and submitted to publishers. • Managed clinical trial data archiving and migration of complex archival structures. • Managed planning and execution of annual Board of Directors and Scientific Advisory Board meetings. • Conducted research to create partner due-diligence dossiers to build awareness and aid in global-level decision making. • Analyzed intussusception data from 7 African countries and created visuals and report. • Leveraged partnerships in Zambia and Thailand; conducted research, field-interviews, and meetings to raise awareness of diarrheal disease in the developing world and contributed to global advocacy.PATH is an international, nonprofit global health organization whose mission is to improve the health of people around the world by advancing technologies, strengthening systems, and encouraging healthy behaviors. PATH develops, adapts, and advances technologies focused on disease diagnostics, vaccine delivery, nutrition, reproductive health, water and sanitation, and other areas. PATH is working with biotechnology and pharmaceutical companies to support the development of vaccines for diseases such as meningitis and pneumonia and to help countries introduce vaccines for childhood illnesses such as rotavirus and Japanese encephalitis.

• Consulted for in-country grassroots economic and development organizations; provided capacity building strategy, support, and direction for community-based organization working on income-generating project and micro-finance. • Taught micro-savings, budgeting, and financial practice at rural women’s empowerment workshop and wrote funding proposals for the establishment of three micro-enterprise vocational training centers to provide vocational training and alternate income opportunities for vulnerable people groups. • Conducted due-diligence research and field-interviews for philanthropic investment. Volunteered with visiting medical camps in rural villages.BRIDGE's mission is to provide community based organizations with the organizational skills needed to sustain their efforts in reducing poverty by strengthening their capacities to plan, implement, manage, and evaluate projects.Dalit Education Center supports education in economic development, skills training, and healthcare. Not For Sale fights modern-day slavery around the world creating enterprise opportunities for vulnerable communities, offering social services to survivors and those at-risk to human trafficking, and evaluating the use of forced labor in mainstream supply chains.

• Streamlined fundraising and public education events by creating and managing comprehensive operations schedules. Executed events with ≤2,500 people in attendance. Engaged donors, speakers, staff, vendors, designers, and the media.• Created and managed budgets, operations, and donor outreach activities.• Worked with vendor to create brand refresh; adapted brand identity to meet visual standards and style guidelines of the University. Authored marketing pieces, press releases, and communications plans to optimize impact of outreach and fundraising campaigns.The Joan B. Kroc Institute for Peace & Justice is at the nexus of practice, policy and scholarship in peacebuilding and human rights. Institute staff work with government and opposition leaders, security personnel, indigenous communities, soldiers and former combatants, business and civil society leaders, and journalists, and bring high-level national and international leaders to campus to discuss cutting-edge issues in peace and justice.

• Instituted company performance reports; created and managed project management database and analyzed budgets. • Created and maintained project management tools to assist CEO with evaluation of vice presidents’ projects’ pipelines and work-in-progress against project timelines. • Wrote, edited, and produced proposals in support of business development team. Wrote project snapshots.IMG is an international, full-service advisory firm of management, financial, development, and operations specialists supporting public and private infrastructure owners, investors, and developers. IMG has advised on over $100 billion of public and private sector transactions across the infrastructure lifecycle located in the Americas, Europe, Africa, and Asia.

• Managed large variable caseload and rotating public affairs duties representing policies and procedures to the public. • Executed final decision on immigration applications to include visitor, work, temporary residency, student, and non-migrant visa types. • Engaged and informed key stakeholder of critical updates.The Embassy of Australia in Washington, D.C. is the diplomatic mission of the Commonwealth of Australia to the United States.

Executive Education, Clinical Development

Education record

Education record

Bachelor Of Arts