Laura J. Szewczyk Email & Phone Number

California, United States

Miami, Florida, US

Ridgeback is Innovating and accelerating life-changing and life-saving solutions for the health and safety of the global population. As Head of Clinical Operations, led the clinical development of Lagevrio/ Molnupiravir (EIDD-2801), Ridgeback Bio’s novel COVID-19 oral therapy, in a global pandemic setting; Initiated novel methods of accelerated study start.

• YOGA ALLIANCE REGISTERED YOGA TEACHER (RYT) 200, Vinyasa Yoga Instructor
• Yoga Flow, San Francisco- Yoga Instructor Nov 2019- Present
• Traverse Gym, South San Francisco- Yoga & Group Fitness Instructor July 2022- Present
• Armando Luna Yoga, San Francisco- Substitute Yoga Instructor Jan 2021- Present
• GenesisFIT, South San Francisco- Yoga instructor May 2019- Sept 2022
• Independent Corporate Yoga Instructor, South San Francisco- July 2012- Dec 2018TRAINING AND APPRENTICESHIP

South San Francisco, CA, US

South San Francisco, CA, US

Accountable for the operational execution of Phase I studies with AMV564, a bivalent, bispecific, T-cell engager, in hematologic malignancies (Myelodysplastic Syndrome and Acute Myeloid Leukemia) and solid tumors, performing duties with minimal guidance or cross functional support, in compliance with study protocol, SOP’s and applicable regulatory.

South San Francisco, California, US

• Provided day to day operational support for a pivotal Phase II Small Cell Lung Cancer study, ensuring completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and.
• Site feasibility assessment and site selection
• Ensured set-up and implementation of effective investigator and site monitor training; coordinated and lead operational and therapeutic area training for internal and external study team members
• Authored and/or edited presentations, training materials, and study documents (including pharmacy, laboratory, operations manuals and newsletters)
• Primary lead for planning of US and ex-US Investigator Meetings; tasks included budget planning and oversight, agenda and slide deck preparation and attendee tracking
• Lead cross-functional team meetings, including vendors; liaised with other functional areas (preclinical development, clinical, safety, regulatory affairs, CMC) in order to accurately coordinate clinical study activities

South San Francisco, CA, US

Provided day to day support for 6 Phase II studies (Oncology, including Solid Tumors, Multiple Myeloma and Lymphoma), through start-up, maintenance, long term follow up and close-out, and one Phase I/II (Multiple Myeloma) study through start up, dose escalation and maintenance.

South San Francisco, CA, US

• Provided in house clinical support for 8 Phase I and I/II studies
• Primary Site Monitor for local site, and co monitor for routine co-monitoring visits with CRO staff. Conducted routine monitoring visits; tasks included SIV presentation, training site staff on protocol and study.

South San Francisco, CA, US

• Primary support person for Sr. VP of Clin Dev through ODAC, filing and approval of Kyprolis NDA
• Acted as lead admin for the department including, interviewing, hiring and training of new administrative staff
• Complete calendar management, edited and created Power Point presentations, agendas, meeting minutes and routine correspondence
• Extensive travel planning domestically and internationally
• On and offsite meeting and event planning including agenda planning, minute taking, material creation and binders
• Worked with greater administrative team to create efficiencies and improve processes

South San Francisco, California, US

• Provided timely, accurate and effective administrative support to the Director of Access Solutions Operations, Director of Coverage & Reimbursement, Program Managers, Senior Planning Managers, and a staff of 30+
• Heavy calendaring and complete calendar management at executive level
• Planned, scheduled and coordinated onsite/offsite meetings; included audio and video conferencing, creation of materials, binders, presentations and agendas and minute taking during meetings
• Served as the Assistant Project Coordinator for the opening of a new Chicago pilot office; participated in the planning, communication, on and off site set-up and support, seeing project through to realization
• Worked with administrative team to develop and streamline processes and improve efficiency department wide

San Francisco, California, US

- Served as a key contact within Central Administration in the areas of Accounts Payable, Human Resources, IT support, Facilities, Educational Program support as well as administrative support for other CTSI central programs as required - Analyst’s duties included maintaining client tracking databases, reviewing systems for operating efficiency,maintaining.

South San Francisco, California, US

- Provided timely, accurate and effective administrative support on two drug study teams (Clinical Operations, Oncology) and several senior level directors (Clinical Science, Oncology) - Facilitated communications including correspondence, mass mailings, email communications for assigned clinical trials (included meetings minutes and mailing of INDSRs).

San Francisco, CA, US

US

Irving, Texas, US

Clinical Trial Design And Management, Biotechnology

Bachelor’S Degree, International Business