Jill Wallace Email and Phone Number

- Serve as Lead Clinical Scientist overseeing scientific conduct of global Early and Late Stage clinical studies for participants with metastatic prostate cancer- Collaborate cross-functionally to execute start-up activities for Phase I/II umbrella protocol through protocol authoring, key study documents development, vendor specification, and oversight of data management processes- Serve as the primary external collaboration contact to facilitate communication and alignment between our internal protocol development team and co-sponsoring external stakeholders- Support regulatory compliance efforts and collaboration with key regulatory bodies such as the FDA, HAs (Health Authorities), IRBs (Institutional Review Boards), and EU Clinical Trials Regulation (CTR) authorities- Led mitigation of challenges arising from the determination of Phase III study futility while prioritizing patient care and adherence to ethical Good Clinical Practice (GCP) standards

- Supported Phase III study Database Lock activities to prepare for upcoming regulatory submissions- Led Medical Monitoring Team meetings for ongoing review of aggregate safety and disposition data - Coordinated preparation for and execution of external Data Monitoring Committee meetings - Served as unblinded Clinical Scientist for Phase III esophageal carcinoma trial by addressing potential unblinding events, cross treatments, and unblinded related queries

Rotate across shifts and departments to provide 24/7 shopfloor Quality support to Operations in 3 vaccine aseptic & non-aseptic production facilitiesComply to regulatory and GMP standards while performing finished product inspections and line clearances to prevent cross-batch contaminationEnsure compliance through permanent inspection readiness initiatives and support of regulatory inspections

Supported clinical and laboratory research focusing on inflammation, immune regulation, and cancer risk in both human subjects and animal models

Penn State Cancer Institute, Community Sciences and Health Outcomes (CSHO) Core, Department of Public Health SciencesDesigned and monitored foundational scientific research and initial study protocol in accordance with all ICH/GCP guidelines to analyze efficacy of patient navigation in women diagnosed with dense breast tissue

Executed pilot study to examine relationship between omega-3 fatty acid intake and breast density in women living in rural Pennsylvania