Greg Ortiz Email and Phone Number

(Acquired by Pfizer Dec 2023)· Global Protocol Lead for 1) Phase 1b/2 Open-Label Study of Disitamab Vedotin Monotherapy or in Combination With Other Anti-Cancer Therapies in Solid Tumors and previously 2) Phase 2 Basket Study of Tucatinib in Combination with Trastuzumab in Subjects with Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations· Direct manager and mentor of 2 Study Managers (NA lead and APAC/LATAM lead) · Functions as the Operations representative on the Clinical Study Team · Assists with design and review of protocols/ICFs and other study documents · Leads in identification, evaluation, and selection of clinical trial sites · Coordinates and manages vendor selection processes and maintains oversight throughout study · Conducts data review · Accountable for completeness of Trial Master Fie and works closely with quality function to ensure inspection readiness. Support audit and/or inspection activities · Primary point of contact for CRO activities in APAC· Contributes to process improvement initiatives and departmental projects

• Lead Study Manager for Phase 1b/2 US-only solid tumor trial and supervisor of 2 Clinical Trial Associates; overseeing imaging vendor, IRT vendor, labs vendor.• Independently lead Internal Study Management Team meeting with input from cross-functional teams, relaying CRO and vendor specific metrics, issues and escalations.• Responsible for delivering and holding vendors accountable to key study quality metrics regarding enrollment, time to entry/SDV/query resolution, lab sample and imaging reconciliation.• Manage the vendor budgets, ensuring the project remains within scope and that out-of-scope activities are identified and handled appropriately or modified by change orders.• Write or contribute to preparation of clinical protocols, lead the adaptation of protocol-amendment required changes to master informed consent form, and function as main escalation point for site-specific questions regarding updated ICFs.• In response to protocol amendment lead system-wide updates to IRT database, EDC and imaging database after careful review of specifications and overall timelines delivering each on time. Responsible for composing and delivering systems trainings to internal colleagues and external partners.• Inspection Readiness study lead responsible for drafting IR Plan and working with QA/GCP, TMF team, and other relevant departments to ensure site documents, and Nektar filing practices are in good order for possible inspections. Instituted quarterly review for team.• Participate in quarterly vendor review to gauge performance of lab, imaging, and IRT vendors, identify risks, and measure performance indicators as compared to agreements within contracts.• Work closely with Clinical Development/Medical Monitor to identify risks to recruitment and retention strategy, address protocol language ambiguities, and to request input into critical documents or study aids for sites or cross functional teams to utilize.

• Lead Study Manager for a global Phase 3 kidney disease trial and supervisor of 4 Clinical Trial Associates.• Lead Study Manager for first-in-human US-only Phase 1 kidney disease trial.• Managed cross functional collaboration for successful IND submission and subsequent response to FDA comments.• Evaluated, selected and managed clinical operation vendors (replacement CRO, lab vendor) to ensure adherence to scope of work, budget and study deliverables.• Worked with Clinical Outsourcing to negotiate vendor and site study budgets and contracts.• Worked closely with CRO to evaluate, select and manage investigational sites.• Lead cross functional clinical trial team (e.g., pre-clinical, manufacturing, data management, safety surveillance, regulatory, biostatistics, and quality assurance).• Contributed to the preparation of clinical program documents (protocols, ICFs, CSRs and submissions, etc.).• Developed, implemented and ensured adherence to the monitoring plan for assigned studies.• Organized several remote Global Investigator Meetings and delivered presentations• Ensured the collection, accuracy and storage of study related documents.• Ensured the review and tracking of IMV reports for content, quality, adherence to GCP and timely submission.• Tracked, measured and reported the status of project milestones.• Assisted in the development and implementation of clinical Standard Operating Procedures and associated tools.• Traveled to and prepared 2 sites for FDA inspection.

• Asia-Pacific lead for Phase 3 global trial in prostate cancer.• European lead for Phase 2 global trial in breast cancer, and Americas lead for Phase 2 global trial in ovarian cancer. Oversaw global CRO on the conduct of the trial and IXRS, imaging and lab vendors.• Lead Study Manager for Legacy Medivation portfolio (Phase 1, 2, and 3 prostate, breast cancer)• Vendor Oversight Lead overseeing full-service study CROs, imaging, and lab vendors.• Accountable for conducting country level feasibility, reviewing Pre-trial Assessment outputs, approving sites, and assessing site activation plans.• Coordinated study/protocol training and supports investigator meetings.• Lead inspection readiness activities related to study management and site readiness; trains CRO and drafts guidance documents for site reference.• Cross Functional Liaison responsible for all study related activities and deliverables derived from Clinician, Clinical Pharmacology Lead, Supply Chain Lead, Statistician, Outcomes Research Representative, Clinical Assay Group, etc.• Drafted the Study Startup, Study Monitoring & protocol recruitment plans; and incorporated cross-functional input as well as that from the CRO into final plan.• Oversaw drug supply management for initial and resupply of study drug to the sites.• As part of final study shut down and data cleaning efforts, supported study level submission readiness by composing CSR Appendices and reviewing narratives submitted by other departments.• Worked proactively with CRO and data management functions to ensure alignment on data flow and timely delivery; implemented data entry standard of 5 business days for pediatric oncology trial, with query resolution standard of 5 days to ensure timely input of data and to ensure subject safety is maintained at highest level.• Supported on-site TMF audit of Legacy Medivation trial documents.

(Acquired by Pfizer Oct 2016)

• In support of Phase 2 US-only lung cancer trial, conducted site visits (pre-study, initiation, interim, and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct.• Provided oversight and evaluation of contract CRA during in-field visits; reviewed subsequent reports and provided feedback.• Reviewed monitoring reports submitted by contract monitors and provided comments while ensuring review process and site follow-up was in compliance with Monitoring Plan guidelines.• Provided back room support for mock FDA/MHRA inspection.

• Ensured the accurate progress of clinical trials from study initiation through study termination.• Served as the primary liaison to the Physician Investigator, the patient, the hospital, and the company or government sponsor.• Developed and executed recruitment plans to meet patient accrual targets for each clinical trial, increasing enrollment by 27% over course of year.

• On a monthly basis monitored 6 nation-wide study sites for each of 3 unique medical device study protocols.• Conducted routine monitoring visits at nationwide research sites monitoring 100% of records. Verified ICFs, protocol adherence, accuracy of data derived from medical records, laboratory results, and source documents.• Conducted site eval visits, SIVs, and performed GCP and protocol-specific training for investigators, nurses and laboratory personnel. Later performed IMVs, and Site Closure Visits.