Paula Cabrera Email & Phone Number

United States

Lead and oversaw the clinical development and execution of the operational strategies of multiple assets in Amgen’s pipeline at the program level in compliance with company SOPs/guidelines, FDA regulations and current ICH GCP guidelines. Implemented numerous patient-oriented solutions across different areas to mitigate or solve challenges. Program-wide management and oversight of risk assessment and mitigation, operational timelines, resourcing, and budgets. Identified and managed clinical investigators/KOLs and sites, CROs, vendors. Line manager and point of escalation of people managers. Global role: US, Europe, Latin America, JAPAC.

Thousand Oaks, California

Led multiple oncology study level planning of the overall operational deliverables. Responsible for the ongoing evaluation of the feasibility of the program strategy. Authored clinical and regulatory documents, target product profiles. Identified, and performed feasibility for the selection of clinical investigators, led investigator meetings and Dose Level Review meetings. Contributed to medical data review, safety, pharmacology and efficacy data in ongoing and completed studies, participated in interim/primary/final analysis. Monitored activities in compliance with FDA regulations and ICH/GCP guidelines. Oversight and point of escalation of regional clinical trial managers, CRAs, CTAs for each region included in all studies assigned. Global role: US, Europe, Latin America, Asia.

Los Angeles, California, United States

• Managed Ab and complex TCR cell therapy oncology clinical trials (solid tumors and Hem/Onc) with dual tracing/suicide gene features• Managed regulatory aspects of numerous IO clinical trials: pre-IND responses, IND submissions, local submissions (IRB, DSMB, ISPRC, IBC, Rad. Safety)• Submitted INDs for first oncology TCR clinical trial with modified stem cells/T cells (featured in CNN), approval within 30 days for 3 INDs (solid tumors, hematol. malig., tracer construct)• Contributed to pre-clinical studies: GLP tox, immunogenicity, integration, cell differentiation (artificial thymic organoids)• Streamlined pre-screening for target antigens to 3-5 biz days• Partnered with BMS, GSK, Vaccinex and Array for combo studies• Managed blood and tissue biobanks• Supervised SSU, conduct, closure, TMF maintenance, audit and monitoring readiness.• Conducted cross-functional study team meetings and protocol training • Reviewed budget and contracts • Conducted clinical data analysis and wrote/reviewed clinical trial documents (ICF, CRF, clinical protocol, pre-clinical reports, assay validation reports)• Wrote press releases, grants (CIRM), scientific abstracts (ASCO, AACR, Genitourinary Cancers Symposium) and manuscripts (Clin Cancer Res)• Developed and obtained IRB approval for patient outreach materials (educational videos to improve trial understanding and flyers)• Supervised CRC, DM, CRA, manufacturing staff• Assisted with patient outreach and collaborated with patient advocacy organizations

• Responsible for project management and operations in the US, Canada and Latin America • Project management of cervical cancer prevention programs based on molecular screening • Regulatory compliance managing diverse product lines intended for clinical diagnostics. • Complaint management of FDA-regulated and research products, Quality Assurance investigation of IVD and research-based instruments and consumables (siRNA, sequencing, high throughput research and IVD testing) • Managed Abbott Diagnostics accounts for low and high throughput clinical hematology testing, Kaiser Permanente and Quest Diagnostics accounts for IVD and research use only testing.

Los Angeles, 90095

• Project Leader of cancer (lymphoma, prostate cancer) and dendritic cell research, funded by the National Institute of Health• Lead multidisciplinary project to identify drugs that can improve muscle function in muscular dystrophies via high throughput screening of drug libraries, funded by the Department of Defense• Identified oncogene that confers resistance to glycosylation mediated cell death • Successfully developed siRNA knock downs for several oncology projects with knock down confirmation at the protein level, followed by development of functional testing to detect impact of the knock down• Generated mutant enzymes (by site-directed mutagenesis) found in the clinic and created clones transfected with mutant vs wild type to compare effect on lymphoma cell death• Supervised undergraduate/graduate students, lab technicians• Wrote grant proposals and scientific articles for publication (first author for Blood, Journal of Biological Chemistry, Expert Review in Clinical Immunology)• Invited speaker at Gordon Research Conference, presented at SPORE (Specialized Programs of Research Excellence), Glycobiology Symposiums, International Congresses of Biochemistry and Molecular Biology.

Postdoctoral Training

Project Management

Doctor Of Philosophy, Immunology