Elizabeth O'Connor Email & Phone Number

Manhattan Beach, California, United States

Precision Promise is an innovative adaptive clinical trial platform designed to accelerate the development of new treatments for pancreatic cancer. With a primary endpoint of overall survival that can include multiple investigational treatments and control arms, each investigational therapy is subject to pre-specified interim analyses before proceeding to the registrational portion of the trial. The design minimizes the number of participants needed to generate licensure-enabling data, accelerating late-stage development and reducing costs compared to non-platform trials.• Responsible for alliance management of arm sponsors (e.g., pharmaceutical companies) interested in their investigational drug being studied on the Precision Promise (PrP) platform.• Engage with PanCAN stakeholders and committees who are contributing to the design of PrP.• Lead efforts to ensure that CRO operational plans and budgets support each new treatment arm’s activation and downstream deliverables.• Develop sponsor SOPs that define clinical operations, drug safety, GMP, and QA processes for overseeing the management and administration of investigational products.• Author or perform clinical science reviews of clinical protocols, data collection and management plans, site training documents, safety narratives, patient profiles, and clinical study reports.

Oakland, California, United States

• Served as credentialed Principal Investigator/Program Director for the Children’s Oncology Group Coordinating Center (COGCC) program at the Public Health Institute, providing vision and strategic direction.• Provided oversight of recruitment, supervision, and performance management for 100+ staff within the COGCC program.• Assured and held program staff accountable for ethical, legal, and scientific integrity in all program activities, including knowledge of and adherence to all federal and state laws.• Developed budgets and SOWs for funders. Monitored and met all post-award reporting requirements and ensured progress reports were completed on time.• Reviewed finance reports and adjusted budgets accordingly.

Monrovia, California, United States

• Led clinical research, data operations, and administration for the Children’s Oncology Group (COG), a National Cancer Institute (NCI)-funded National Clinical Trials Network (NCTN) group and NCI Community Oncology Research Program (NCORP) research base.• Provided organizational direction of central operations, including supervising department directors. Allocated resources and personnel to support 220+ children’s hospitals and academic research institutions enrolling subjects and submitting data on 75+ active clinical trials.• Engaged with scientific leadership to inform strategic planning for operational infrastructure and ensure it addressed the evolving complexities of COG’s trial portfolio.• Guided enhancements to information technology infrastructure and data capture systems in support of COG’s expanding scope of research (e.g., precision medicine, patient-reported outcomes (PROs), and health economics & outcomes research).• Negotiated contracts and budgets with pharmaceutical industry partners, including evaluating, selecting, and managing CROs, central laboratories, and other clinical study vendors. • Authored grants and budget proposals awarded to the broader research program.• Drafted, reviewed, and approved SOPs and policies that promote research quality and integrity. • Represented COG and Group Chair at national scientific and federal administrative meetings. • Planned and presented at semi-annual COG-hosted conferences and leadership retreats.• Served as a member of major committees, including the COG Executive Committee, the COG Voting Body (220+ member site-responsible investigators), and the COG Foundation Board.

Arcadia, California, United States

• Directed operations of a 21-institution NCI-funded pediatric oncology early-phase drug development network that served to study the safety of investigational new drugs expeditiously.• Defined and implemented processes and infrastructure to conduct developmental therapeutic clinical trials that collect safety and pharmacokinetic data to determine optimal dosing.• Trained and managed a multi-disciplinary team comprising protocol writers, study builders, data managers, and statisticians who supported the unique demands of early-phase clinical trials.• Filed and maintained all group-held investigational new drug (IND) applications with the FDA and served as the contact for operational issues during the conduct of industry-sponsored trials.

Arcadia, California, United States

• Co-wrote phase 1, 2, and 3 clinical trial protocols with pediatric oncologists, designed treatment roadmaps, and wrote sample informed consent documents and site training materials.• Managed submissions to and drafted responses for all required reviews and regulatory approvals of new studies and amendments. Authored all site communications for ongoing trials.

Los Angeles, California, United States

Neurosurgery, Official Journal of the Congress of Neurological Surgeons • Verified requisite composition of submitted scientific manuscripts for international medical journal and summarized peer reviews for use by editor in making acceptance decisions.

Boston, Massachusetts, United States

• Secured resources for patients with needs not met by the hospital and facilitated discharge plans for patients requiring skilled nursing home or rehabilitation hospital placement.

Master Of Public Health - Mph

Bachelor Of Arts - Ba, English