Laura J. Szewczyk

Laura J. Szewczyk Email and Phone Number

Senior Director, Clinical Operations @ Character Biosciences
California, United States
Laura J. Szewczyk's Location
San Francisco Bay Area, United States, United States
Laura J. Szewczyk's Contact Details
About Laura J. Szewczyk

Dynamic, tenacious, and motivated Clinical Research Professional best suited for fast paced, start-up environments where creative problem solving, thinking on your feet, and adapting quickly are essential in getting much needed drugs to patients.

Laura J. Szewczyk's Current Company Details
Character Biosciences

Character Biosciences

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Senior Director, Clinical Operations
California, United States
Laura J. Szewczyk Work Experience Details
  • Character Biosciences
    Senior Director, Clinical Operations
    Character Biosciences
    California, United States
  • Ridgeback Biotherapeutics
    Director, Clinical Operations
    Ridgeback Biotherapeutics May 2020 - Present
    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 up, study execution and study finalization to allow for seamless movement through the phases of development.Providing clinical development support for Ebanga (ansuvimab-zykl) a human monoclonal antibody indicated for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients.
  • Laura Jayne Yoga
    Certified Yoga Instructor & Lagree Coach
    Laura Jayne Yoga Jun 2012 - Present
    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 • 20-hour immersion, Bhakti Flow, Rusty Wells Aug 2022• Teacher Training Apprentice, 200 hour Embody Truth Yoga Teacher Training, Dana Damara (Yoga Flow Ocean) Sept 2019-March 2020• 50-hour certificate, Bhakti Flow, Rusty Wells 2017• 300-hour training, Vinyasa Yoga, Mark Stephens, 2017• 50-hour training, Prenatal Yoga, Mama Tree, Jane Austin 2013• 200-hour certification, Yoga Tree, San Francisco 2012• Adult, Child and Baby First Aid/CPR/AED Certified, Red Cross Feb 2022
  • Catalyst Biosciences
    Sr. Clinical Trial Manager, Hematology
    Catalyst Biosciences Jan 2020 - Apr 2020
    South San Francisco, Ca, Us
  • Catalyst Biosciences
    Clinical Trial Manager, Hematology
    Catalyst Biosciences Jun 2019 - Jan 2020
    South San Francisco, Ca, Us
  • Amphivena Therapeutics Inc.
    Clinical Trial Manager, Oncology
    Amphivena Therapeutics Inc. Jan 2018 - Jun 2019
    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 requirements, in a small start-up environment.
  • Stemcentrx, Inc.
    Sr. Study Management Associate, Oncology
    Stemcentrx, Inc. Jan 2016 - Jan 2018
    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 other regulatory requirements; Study lead for US and Ex-US through study start up, and US lead through maintenance, data cleaning/ data lock activities and study close out• 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• Supported Program Lead in coordinating clinical study timelines to meet critical milestones; escalated issues that may jeopardized timelines and deliverables• Provided regular updates of study progression to Program Lead • Participated in clinical aspects of timely data cleaning• Lead the data reconciliation process for Central Imaging vendor through multiple Interim Analyses• Provided oversight and direction to study team members, including vendors, for study deliverables
  • Onyx Pharmaceuticals, Inc., An Amgen Subsidiary
    Clinical Research Associate, Oncology
    Onyx Pharmaceuticals, Inc., An Amgen Subsidiary Feb 2014 - Dec 2015
    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.
  • Onyx Pharmaceuticals, Inc., An Amgen Subsidiary
    Clinical Trial Assistant, Oncology
    Onyx Pharmaceuticals, Inc., An Amgen Subsidiary Jul 2012 - Feb 2014
    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 procedures, review of patient’s charts and data, verifying site’s Regulatory, Pharmacy and PI binders
  • Onyx Pharmaceuticals, Inc., An Amgen Subsidiary
    Sr. Administrative Professional To Sr. Vp Of Clinical Development
    Onyx Pharmaceuticals, Inc., An Amgen Subsidiary Feb 2011 - Jul 2012
    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• Exercised sound judgment and discretion of sensitive/confidential information
  • Genentech
    Sr Administrative Professional, Access Solutions
    Genentech Apr 2010 - Feb 2011
    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
  • Ucsf
    Administrative Analyst
    Ucsf Jul 2009 - Apr 2010
    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 schedule and coordinating meetings and making recommendations for process improvements - Provided analytical and operational support to the CTSI Director of Finance & Operations - Created and maintained financial files, coordinated recharge processing, tracked and consolidated documents for annual progress reports - Created purchase orders, check requests and journal entries in People Soft
  • Genentech
    Administrative Professional, Biooncology
    Genentech Feb 2009 - Jul 2009
    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) - Worked as a member of the Administrative Professional Team to improve the efficiency of administrative processes while providing a high-level of customer service - Planned, scheduled and coordinated onsite/offsite meetings; coordinated domestic and international travel and attended conferences
  • Jmp Securities
    Road Show Coordinator/ Marketing Assistant
    Jmp Securities Dec 2006 - Jul 2007
    San Francisco, Ca, Us
  • Mckenzie River Corp
    Travel Coordinator/Office Administrator/ Executive Assistant
    Mckenzie River Corp Oct 2005 - Nov 2006
    Us
  • It Convergence
    Office Administrator/ Recruiter
    It Convergence Apr 2005 - Oct 2005
    Irving, Texas, Us

Laura J. Szewczyk Skills

Event Planning Management Biotechnology Clinical Research Research Clinical Trials Project Management Time Management Marketing Oncology Microsoft Office Healthcare Fundraising Data Analysis Clinical Operations Pharmaceutical Industry Microsoft Excel Community Outreach Nonprofits Yoga Clinical Development Gcp Leadership Cro Management Data Cleaning Clinical Site Monitoring Volunteer Management Microsoft Powerpoint Mentoring

Laura J. Szewczyk Education Details

  • San Francisco State University
    San Francisco State University
    Biotechnology
  • San Francisco State University
    San Francisco State University
    International Business

Frequently Asked Questions about Laura J. Szewczyk

What company does Laura J. Szewczyk work for?

Laura J. Szewczyk works for Character Biosciences

What is Laura J. Szewczyk's role at the current company?

Laura J. Szewczyk's current role is Senior Director, Clinical Operations.

What is Laura J. Szewczyk's email address?

Laura J. Szewczyk's email address is la****@****ail.com

What schools did Laura J. Szewczyk attend?

Laura J. Szewczyk attended San Francisco State University, San Francisco State University.

What are some of Laura J. Szewczyk's interests?

Laura J. Szewczyk has interest in Health.

What skills is Laura J. Szewczyk known for?

Laura J. Szewczyk has skills like Event Planning, Management, Biotechnology, Clinical Research, Research, Clinical Trials, Project Management, Time Management, Marketing, Oncology, Microsoft Office, Healthcare.

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