Yvonne Scott MBA

• Provides leadership to the clinical operations team working on the assigned program. • Lead in the selection of qualified investigator and sites and provide recommendations to clients • Actively participate in all aspects of clinical trials operations, including the coordination, writing, review and/or finalization of clinical trial protocol, consent forms, CRFs/eCRFs, study plans, safety reviews, SOPs and other essential regulatory documents • Develop and manage study timelines • Provides program level oversight to vendors, central lab, and imaging. • Participates in the selection, training and evaluation of clinical trial managers and clinical trial management associates to ensure the efficient operation of the function • Attends and presents at cross-functional meetings as needed to represent clinical operations and program level items • Proactively identifies potential issues/risks across the program and recommends/implements solutions. • Developing appropriate early warning systems of potential obstacles to the successful completion of the projects; analyzes information and develops innovative solutions to challenges • Responsible for change management on all assigned projects • Supports contracts and proposals with final project contract execution and CIS documentation by the project team. Represents senior management in negotiation of contracts as appropriate • Assist in the preparations of request for proposals in collaboration with other internal team members, coordinate the evaluation of the proposals and provide input for proposal defense presentation to prospective clients • Examine functional issues from a broader organizational perspective and develop a strategy to implement with a cross-functional team • Leads the development, review and implementation of departmental SOPs and processes.

• Manages projects of full scope regional and global projects. Responsible for project team leadership • Responsible for building and maintaining positive client relationships • Reviewing and identifying project study trends and proactively responding to client and respective team members • Developing appropriate early warning systems of potential obstacles to the successful completion of the projects; analyzes information and develops innovative solutions to challenges • Identifying, define, document training requirements and assure project level compliance with study specific training requirements • Responsible for change management on all assigned projects • Responsible for assuring projects assigned are run according to SOPs and WP as refined in the contract • Responsible for assuring project timelines are met as per contract • Responsible for identifying processes which need updating and documenting that to the direct line manager or divisional lead • Responsible for maintaining client relationships for all assigned work, keeping all project reporting current, and assuring executive management is aware • Assists with developing, documenting, and updating internal processes and processes required for consistency across programs such as SOPs, working practices, and related quality assurance forms • Assists in the development and delivery of capability and proposal defense presentations to prospective clients • Supports Contracts and Proposals with final project contract execution and CIS documentation by the project team. Represents senior management in negotiation of contracts as appropriate • Participates in the performance appraisal program by providing timely and accurate feedback regarding the performance of respective team members at least annually • Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research • Responsible to maintain personal currency documentation for SOPs and CAPA completion

• Scientific, strategic and operational leader in planning and executing complex early, Phase 1 clinical studies in the program. • Manage 4 direct reports and teams of 22 staffs • Oversee a multidisciplinary Phase 1 program for all clinical development deliverables (scope, budget, activation timeline, resources, quality and risk.) • Key talent is the ability to strategize and support the unique needs of each clinic to drive enrollment and met program goals. • Develop and maintain infrastructure for experimental therapeutic clinic to streamline efficiency, sustain program growth and deviation reduction.

Leadership Management • Actively participate in developing departmental SOP, orientation, and on-boarding process • Restructured Phase 1 program operation and personnel which led to more than double the accruals for FY2015. • Participate in interviewing/hiring process of the clinical trial office • Created an educational program for early phase oncology/hematology entry level research personnel • Collaborated with Sr. Staff members in developed standard scoring and successfully implemented workload assessment tool • Created and added new positions: ARNP and a Project Manager to support the Phase 1 program Regulatory Compliance • Oversee the study compliance by working with the regulatory body to ensure all studies adhere to FDA and institution standard guidelines • Created checklist and successfully implemented standard process based on GCP guideline led to closure of ICF CAPA • Oversee of contract/budget of all studies in the program Clinical Management • Manage Phase 1 Program portfolio which include all site disease groups of both hematology and oncology malignancies • Manage day-to-day operations of 15 personnel including clinical research coordinators, clinical data coordinators, regulatory personnel • Primary contact for sponsors and medical oncologists in developing research portfolios, opening new studies, determining workflow, managing enrollments, and expanding research for the Phase 1 program • Successfully recruited high profile, scientifically sound early phase studies with innovative treatment approach utilizing oncolytic viruses, immunotherapies alone or in combinations with standard chemo therapy to the program, some of which Sylvester is the primary participate and/or first site globally to put a patient on a novice treatment • Successfully collaborated with clinical administrative and leaderships to move all research patients to a separate research unit for all early phase patients

• Managed over 40 hematologic malignancies studies including leukemia, lymphoma, myeloma, bone marrow transplant, and viral malignant diseases • Worked with SDG investigators to manage clinical trial portfolios including coordinate activities associated with initiation and study closure of protocols • actively screened and performed informed consent patients for Phase II-IV within the site disease group • Maintained deviation, AE, and SAE logs and communicated the findings to internal institution IRB, Sponsors, and FDA as per protocols indicated • Performed all aspects of regulatory submissions during continuing review and DSMC • Served as primary contact between investigators and sponsors for any research related activities • Actively participated in CAPA process and development of departmental SOP to align with CAPA commitments and improvement in research processes and procedures conducting at SCCC

Team Leadership • Served as member of the hiring process for data management team • Developed and maintained new hire on-boarding process and training to ensure a quick, effective ramp up period and continued development for individuals assigned to Multiple Myeloma group • Trained and supervised new hires on disease specifics, data entry, CIBMTR/forms and CRID/Pre-Ted/Post-Ted submittals through Agnis • Mentored new hires and nurses during their ramp time with the group • Led and coordinated work flow and special projects to team members Regulatory Compliance • Led coordination of regulatory submissions, IND-related and protocol documents per: o Food and Drug Administration (FDA) o National Cancer Institute (NCI) o Sponsor standard operating procedures (SOPs) o Institutional Review Board (IRB) o Institutional and departmental standards and processes • Developed and maintained departmental regulatory document control system • Interpreted and communicated changes to PIs and appropriate team members, including management • Interacted with pharmaceutical company representatives, NCI agents, physicians and staff Clinical Management • Successfully developed and maintained Quality Assurance protocol and related documents in accordance with institutional and federal guidelines governing clinical research and lab protocols • Enhanced patient care by screening patients for eligibility, obtaining informed consent, ordering labs and tests required per protocols, and monitoring for symptoms and changes in treatment • Served as point of contact for patients and families with questions regarding treatment on protocol • Attended patient rounds with in-patient PI and clinic team to assess current adverse patient events

Team Leadership • Served as member of the hiring process for data management team • Developed and maintained new hire on-boarding process and training to ensure a quick, effective ramp up period and continued development for individuals assigned to Multiple Myeloma group • Trained and supervised new hires on disease specifics, data entry, CIBMTR/forms and CRID/Pre-Ted/Post-Ted submittals through Agnis • Mentored new hires and nurses during their ramp time with the group • Led and coordinated work flow and special projects to team members Data Management • Managed and led ongoing database development efforts to remain current in accordance with Myeloma international working group guidelines • Responsible for implementing new development of the Amyloidosis database • Ran protocol database queries, building and validating data for requested abstracts and publications • Managed data entry for incoming transplant subject visits including medications, symptoms, medical procedures, AEs and SAEs, and provide ad hoc queries and reporting • Led and organized weekly outcome meetings for special projects, including morbidity and mortality conferences and graft failure meetings • Maintained reporting requirements to the Center for International of Blood & Bone Marrow Transplant Research (CIBMTR) on D100, semi-annually and annually

Data Management • Managed and led ongoing database development efforts to remain current in accordance with Myeloma international working group guidelines • Responsible for implementing new development of the Amyloidosis database • Ran protocol database queries, building and validating data for requested abstracts and publications • Managed data entry for incoming transplant subject visits including medications, symptoms, medical procedures, AEs and SAEs, and provide ad hoc queries and reporting • Led and organized weekly outcome meetings for special projects, including morbidity and mortality conferences and graft failure meetings • Maintained reporting requirements to the Center for International of Blood & Bone Marrow Transplant Research (CIBMTR) on D100, semi-annually and annually

Data Management • Managed data entry for incoming transplant subject visits including medications, symptoms, medical procedures, AEs and SAEs • Led and organized weekly outcome meetings • Maintained reporting requirements to the Center for International of Blood & Bone Marrow Transplant Research (CIBMTR) on D100, semi-annually and annually

MBA-Health Care Management (2019)