Associate Director of Clinical Operations

• Aug 2022 - Present

Senior Project Manager

• Nov 2018 - Aug 2022

Ensure the execution of clinical study activities, from study start-up through close-out, are conducted with upmost quality and in accordance with study timeline and objectives. Provide management with routine updates regarding the status of ongoing studies. Ensure the consistency of operational activities across studies and indications. Review the clinical study protocol and supporting documents– Statistical Analysis Plan, CRFs, Data Management Plan, Clinical Study Report, monitoring plan, communication plan, timeline, etc. to ensure seamless integration between clinical objectives and study performance. In collaboration with the study team, develop and implement subject recruitment strategies, and ensure enrollment remains on track. Manage the vendor evaluation, selection, and contract process for outsourced activities. Develop and implement vendor oversight plans for outsourced activities; ensure documentation of oversight is appropriate. In collaboration with the Clinical Research Organization (CRO), ensure clinical monitoring resourcing needs and issue resolution are adequate for the study. Review vendor-generated documents for accuracy, quality and consistency. Develop and maintain relationships with internal and external stakeholders, including investigators and vendors. Collaborate with consultants and contractors on clinical study activities. Contribute to the development and implementation of standard operating procedures (SOPs) and common work practices. Complete other study and/or clinical operations activities, as needed.

Clinical Operations Consultant

• Dec 2017 - Nov 2018

Develops, manages, and tracks clinical study operations, projects, SOPS, protocols, budgets, vendor and CRO oversight plans, vendor and site selection, patient recruitment, clinical staff training, investigator and ethic review boards, team communications, CRF writing, adverse event reporting, pharmacovigilance. Ensures GCP compliance, Develops, manages, and tracks clinical study operations, projects, SOPS, protocols, budgets, vendor and CRO oversight plans, vendor and site selection, patient recruitment, clinical staff training, investigator and ethic review boards, team communications, CRF writing, adverse event reporting, pharmacovigilance. Ensures GCP compliance,

Clinical Operations Consultant/Manager

• Jul 2016 - Nov 2018

Develop Clinical Operations Department Ensure that all aspects of GCP are complied with at all times through provision of training at start-up and initiation meetings for clinical trials and on-going SOP development. Solid understanding of pharmaceutical clinical development processes and clinical monitoring Develop SOP's, protocols, budgets and vendor oversight plans Select vendors Ensure the smooth running of the clinical research department by developing systems to track projects including all study, investigator and ethical review board information, patient recruitment activity and financial management. Implement training programs clinical staff with topics that include: principles and practices of project management, team communication, computer software and IT training, protocol and CRF writing, adverse event reporting and the importance of pharmacovigilance, and budget control and reporting. CSR Preparation IND Preparation and planning Protocol Review

Senior Clinical Project Manager

• Oct 2015 - Sep 2016

Execution of clinical study/studies according to global regulatory requirements (including but not limited to US CFR, EU CTD, and ICH GCP) and Takeda SOPs, and supporting clinical strategy defined in Clinical Study Plan (CSP) in support of the Integrated Global Development Plan (IGDP). Leadership of the cross functional Study Execution Team (SET), including Takeda functions, Strategic Partners and other vendors, to ensure study objectives are met, on time and within budget. Responsible for providing study level updates, including timelines & budget, to the cross-functional Clinical Program Team (CPT) ensuring that any study issues, with proposed solutions, are escalated to the CPT, as appropriate. Management of the study budget, including Task Orders, Change Orders, invoice approval and financial reconciliation process.

Senior Study Manager

• Jan 2011 - Sep 2015

Execution of clinical study/studies according to global regulatory requirements (including but not limited to US CFR, EU CTD, and ICH GCP) and Takeda SOPs, and supporting clinical strategy defined in Clinical Study Plan (CSP) in support of the Integrated Global Development Plan (IGDP). Leadership of the cross functional Study Execution Team (SET), including Takeda functions, Strategic Partners and other vendors, to ensure study objectives are met, on time and within budget. Responsible for providing study level updates, including timelines & budget, to the cross-functional Clinical Program Team (CPT) ensuring that any study issues, with proposed solutions, are escalated to the CPT, as appropriate. Management of the study budget, including Task Orders, Change Orders, invoice approval and financial reconciliation process.

Regional Oncology Study Manager (Consultant)

• Jan 2010 - Jan 2011

• Completes project activities associated with monitoring functions of Phase I/II adult and pediatric oncology clinical research studies while developing an understanding of the drug development process, Good Clinical Practices, and relevant regulations • Provide clinical and technical support for CRA I and administrative staff • Performs management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures (PSOPs)

Oncology Study Manager

• May 2007 - Feb 2010

• Completes project activities associated with monitoring functions of Phase I/II oncology clinical research studies while developing an understanding of the drug development process, Good Clinical Practices, and relevant regulations • Provide clinical and technical support for CRA I and administrative staff • Performs management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures (PSOPs)

Study Manager

• 2007 - 2009