Ashlee Brooke Gonzales

• Reporting to Vice President of Operations, acted as clinical operations business and portfolio manager successfully streamlining process for eight first in human (FIH) study teams and across multiple internal functional groups.
• Delivered strategic oversight of global programs for FIH oncology and psoriasis studies.
• Increased operational excellence by developing updated study plans, monitoring plans and informed consent templates, reducing issues portfolio-wide.
• Improved study metrics and mitigated milestone delays with clinical research organization (CRO), acting as primary escalation contact and governance representative.
• Successfully implemented cross-functional processes for providing clinical development team updates, clinical trial metrics tracking, expedited study start-up and expedited clinical trial closure.
• In collaboration with Quality Assurance, developed risk-based clinical operations oversight processes.
• Delivered effective onboarding and training to new employees and cross-trained staff members on job roles to maximize coverage.
• Collaboratively delegated tasks to staff members, monitored completion of duties and provided support to enhance performance.
• Implemented new standard operating procedures (SOPs), work instructions (WIs) and conducted staff training.
• Reviewed operational policies and recommended solutions and change to Vice President of Clinical Operations.

• Operational oversight for phase I-III global clinical research trials supporting timely study milestones and data locks.
• U.S. training leader and primary point person for Veeva Vault electronic trial master file (eTMF) and clinical trial management system (CTMS).
• UCLA Institutional Point Person: Responsible for streamlining operations across BMS portfolio of projects at all UCLA network locations as well as ensuring process improvements were executed in collaboration with key UCLA and BMS stakeholders.
• Regional Clinical Operations Protocol Review Team: Responsible for new protocol/protocol amendment review for necessary operational modifications.
• Psoriatic Arthritis Therapeutic Area Point Person: Leveraging relationships with field medical, established nationwide therapeutic area touch point to improve communications/collaborations between Field Medical and Regional Operations associates.
• Acute Leukemia Forum 2022 attendee.

• Site monitor for globally-run oncology trials in accordance with FDA requirements, utilizing risk-based monitoring approach with emphasis on early phase, chimeric antigen receptor t-cell therapy (CAR-T) and radioligand therapies.
• TRIO U.S. Network Lead: Partnership with TRIO leadership and Novartis account management to ensure aligned, metrics-based portfolio deliverable objectives, streamlined study start-up processes and increased pipeline exposure for TRIO Oncology Network of physicians nationwide.
• Project Deliverable Specialist: U.S. CRA liaison to global program managers, providing data cleaning oversight for RAVE clinical database and vendor management systems. Managing resource allocation as needed for U.S. trial monitoring.
• FOCUS Hub Chair: Clinical Development and Medical Affairs collaborative site outreach pursuit which established and improved new/existing PI relationships; aiming to optimize trial participation with focus on increasing enrollment, participant diversity and shrinking enrollment timelines.
• Translational Oncology FIH Operational Site Selection Representative: in collaboration with field medical, executed Novartis FIH site qualification procedures for adoption into Novartis preferred site program.
• CAR-T Regional Subject Matter Expert: Lead CRA for feasibility, site selection, site readiness, project-specific training, and operational improvement strategies.

• Responsible for operational oversight of phase I-III clinical research trial site staff for over 15 sites.

Key Achievements:

• Two-time recipient of Extra Effort Award for outstanding overall CAR-T protocol execution and site relationship building efforts at key CAR-T sites
• Promoted to Clinical Research Associate II in 2015
• Promoted to Novartis full-time employee in 2016

• Hematology/Oncology research unit manager overseeing site staff including interviewing, hiring, onboarding, training, mentoring, performance evaluations and key performance tracking.
• Executed cross-functional, multi-centered restructure, implementing operational process improvements still in place at UCLA today.
• Promoted from research coordinator to unit manager, overseeing 25 staff members in Aug 2012.

• Execution of molecular assays using pancreatic cancer cell-lines both in vitro and in mouse models in collaboration with post-doctoral staff for PI bench research projects.
• Authored and submitted grants for bench research and PI-initiated clinical research.
• Coordinated clinical research trials in acromegaly and neuroendocrine tumors.

• Determined karyotypic and genetic status in neoplastic and pre-neoplastic hematologic disorders.