Lillian Lee, Pmp Email & Phone Number

Alameda, California, Us

Palo Alto, California, Us

San Rafael, Ca, Us

Study Execution Team lead for PKU gene therapy program, including an observational study and a Phase 1/2 study.

San Rafael, Ca, Us

Study Execution Team lead for PKU program that culminated in BLA approval of Palynziq in May 2018. Collaborated with commercial launch team to facilitate transition of clinical trial subjects to commercial product.

San Rafael, Ca, Us

San Rafael, Ca, Us

Study lead for Phase II and pivotal Phase III studies. Create study plans, documents, templates, and instructional materials for training. Train internal team members, investigators and staff at site visits, investigator meetings, monthly study coordinator calls. Study Start-Up: Manage Institutional Review Board (IRB) and ancillary committee submissions, site budget negotiations, and coordinate release of investigational product (IP). Manage various vendors (central & specialty labs, central IRB, psychometric outcomes, IXRS, clinical supplies) from RFP through selection to ensure services meet study needs. Monitoring Oversight: Review reports and provide support to regional monitors for resolution of site questions. Data Cleaning: Review data listings and query sites to ensure accuracy of information captured. Work with Data Manager to develop cross-functional data cleaning plan.Recruitment: Collaborate creatively with sites to recruit and enroll subjects to meet aggressive program deadlines in a rare disease population. Protocol Development: Developed investigational plan and study procedures for 3 protocols and 4 amendments, ensuring feasibility of operational aspects.

San Rafael, Ca, Us

San Rafael, Ca, Us

Alameda, California, Us

Lead Clinical Trial Manager for a Phase I POC study in GBM. Provided critical support for 4 CTMs on global dose-finding, safety and efficacy studies.• Protocol Development: Coordinated with Clinical Lead and functional groups to operationalize a Phase 1 protocol amendment. Responsible for authoring revisions to study methodology, including updates to study assessments, to reflect new study design. Guided amendment through various reviews, incorporating comments from cross-functional leads. Authored corresponding ICFs. Reviewed updated lab manuals, sample collection kits and CRFs.• Study management and logistics: Managed start-up activities, from site selection to regulatory document review for site activation. Reviewed and approved sponsor template and site ICFs, back-translations of ex-US ICFs, CRFs, and presentations for kick-off meetings, site initiation visits, and team trainings. Created study guidance documents and spreadsheets to manage information on site start-up status, regulatory submissions, and enrollment. Verified accuracy of information in CTMS transfers from CROs. Reported study metrics and weekly updates to senior management to identify issues and solutions. Point of contact for questions from CRO, IRB, third-party vendors, and sites. Ensured trials are conducted in compliance with SOPs, ICH, and GCP guidelines. • Essential Documents: Reviewed regulatory and site activation documents to ensure accuracy for approval and archiving to TMF.• Vendor management: Reviewed Scopes of Work, Communication Plans, Site Reference Manuals and guidance documents for CROs and third party vendors. Fostered rapport and worked closely on all aspects of study management to ensure study deliverables are met per designated timelines. Reviewed monthly metrics to address challenges and propose mitigations. • Clinical Supplies: Managed drug authorizations and worked with central lab vendor and Clinical Supplies team to ensure continuous supply of study materials.

Alameda, California, Us

Performed in vivo PD, PK, and efficacy studies for lead optimization projects. • High throughput screening lead: Routinely led intricate HTS studies in mice. Selected as lead for three PK studies, which were critical for advancement of lead compounds, each involving ~200 mice and timely orchestration of pharmacology personnel.• UCSF Collaboration: Selected as study lead for a complex pulmonary metastasis study in collaboration with researchers from the University of California, San Francisco for scientific publication. • Study reports: Prepared data releases to upper management and wrote study reports for lead compounds for five pre-IND programs. Updated a data-formatting protocol and templates for a new study type.

Us

Bachelor Of Arts (B.A.), Cell/Cellular And Molecular Biology

High School