Mark Lisowski Email & Phone Number

Wisconsin, United States

Arden Hills, Mn

Responsible for participating in cross functional development teams as the clinical representative in support of the organization's business objectives for product development and/or commercialization as well as sustaining. Duties include:• Writing Clinical Evaluation Reports • Evaluate scientific literature, clinical trial data, and publications• Review hazard analyses and other risk documents• Review product complaint data• Analyze scientific data• Collaborate on risk assessment and writing of product labeling• Collaborates cross-functionally with Sales and Marketing, R&D, Regulatory Affairs, Quality, and Medical Director/Medical Safety to drive toward project deliverables

Arden Hills, Mn

Manage all aspects of preclinical studies conducted at the RTC. Duties included:• Efficiently and effectively manage multiple projects based on business priority• Organize cross-functional meetings with Sponsor teams, RTC management, and technical advisors to determine study design and study endpoint / objectives• Write, submit, review and update study protocols to ensure compliance with on-site SOPs, GLP, Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), Institutional Animal Care and Use Committees (IACUC), USDA and FDA standards and regulations• Data analysis / assessment, interpretation and final report generation• Key participant in assessing compliance of GLP studies conducted at the RTC• Serve as a mentor to technical staff for study management duties• Teach Microsoft Excel beginner and advanced courses• Awards:o Preclinical Project Impact Award (July 2018). Remediation Supporto Advancing Research for Life Award (June 2018). Hemostatic Agentso KPDP Leadership Award (First Quarter 2017). Ranger IDE Preclinical Optimizationso Project Impact Award (Jul 2016). Recognition of Exhibiting Preclinical High Performance and Winning Spirit Values – Ranger Drug Coated Balloon Projecto Endoscopy Innovation Challenge Team Winner (2016)

Osceola, Wi

Design, oversee, manage and execute scientific research. Duties include:• Supervise Study Directors and Study Managers• Conduct introductory meetings with clients to develop study design, and correspond with clients to determine their scientific goals for specific medical device studies• Serve as the primary preclinical contact and liaison for all research-related correspondence throughout the duration of a study• Develop effective partnerships with external clients and internal staff• Organize and direct cross-functional meetings (management, scientific staff, quality assurance, external clients) to address logistical details encompassed within a study• Efficiently and effectively manage multiple projects based on business priority• Write, submit, review and update study protocols to ensure compliance with on-site SOPs, GLP, Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), Institutional Animal Care and Use Committees (IACUC), USDA and FDA standards and regulations• Initiate and implement process improvement strategies, including study data collection form and study protocol / report template development• Data analysis / assessment, interpretation and final report generation; appropriate distribution and notification of study data to relevant internal / external personnel

Design, oversee, manage and execute scientific research. Duties include:• Supervise Reporting, Surgery (2013-2014), Necropsy and Clinical Pathology (2010-2014) Departments• Conduct introductory meetings with clients to develop study design, and correspond with clients to determine their scientific goals for specific medical device studies• Serve as the primary preclinical contact and liaison for all research-related correspondence throughout the duration of a study• Develop effective partnerships with external clients and internal staff• Organize and direct cross-functional meetings (management, scientific staff, quality assurance, external clients) to address logistical details encompassed within a study• Efficiently and effectively manage multiple projects based on business priority• Write, submit, review and update study protocols to ensure compliance with on-site SOPs, GLP, Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), Institutional Animal Care and Use Committees (IACUC), USDA and FDA standards and regulations• Initiate and implement process improvement strategies, including study data collection form and study protocol / report template development• Data analysis / assessment, interpretation and final report generation; appropriate distribution and notification of study data to relevant internal / external personnel

Osceola, Wi

• Serve as the primary preclinical contact and liaison for all research-related correspondence throughout the duration of a study• Develop effective partnerships with external clients and internal staff• Organize and direct cross-functional meetings (management, scientific staff, quality assurance, external clients) to address logistical details encompassed within a study• Efficiently and effectively manage multiple projects based on business priority• Write, submit, review and update study protocols to ensure compliance with on-site SOPs, GLP, Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), Institutional Animal Care and Use Committees (IACUC), USDA and FDA standards and regulations• Initiate and implement process improvement strategies, including study data collection form and study protocol / report template development• Data analysis / assessment, interpretation and final report generation; appropriate distribution and notification of study data to relevant internal / external personnel

St. Paul, Mn

Managed all aspects of custom studies performed within In-Life Services. Duties included:• Responsible for study planning and design, organization, staffing, data analysis, final report generation and sponsor communication• Provided direct custom study planning for In-Life Services and clients in order to provide clients with a single effective source• Wrote and reviewed GLP and non-GLP study designs and protocols; performed studies and completed final study reports; appropriate distribution and notification of study data to relevant internal / external personnel

Maple Grove, Mn

Established and managed preclinical studies to support interventional cardiovascular products. Duties included:• Developed and executed preclinical protocols• Drove site qualification and compliance with GLP guidelines• Developed and administered adverse event database; developed study data collection forms• Authored regulatory / preclinical submissions intended for PMA annual reports, PMA deficiency letters and Japanese regulatory submissions• Planned and implemented resources to support research and development teams• Developed budget projections and facilitated contract site negotiations• Responsible for management, maintenance and execution of preclinical projects• Collected, analyzed and drafted reports of preclinical results; appropriate distribution and notification of study data to relevant internal / external personnel• Drove communication between and within cross-functional teams

St. Paul, Mn

Perform in vivo and in vitro oncology clinical correlate studies for immune response modifiers. Duties included:• Model development and proof of concept• Data analysis / assessment, report / publication generation; appropriate distribution and notification of study data to relevant internal / external personnel• Effectively communicate across cross-functional teams

St. Paul, Mn

Performed in vivo and in vitro studies to determine toxicity of immune response modifiers. Duties included:• Study Coordinator for GLP toxicology studies• Study Director for research and development (non-GLP) studies• Database Administrator for 21 CFR Part 11-compliant data capture software systems• Participated in FDA audits• Authored departmental IACUC protocols• Data analysis / assessment, and protocol and report generation; appropriate distribution and notification of study data to relevant internal personnel• Effectively communicated across cross-functional teams• Trained in Six Sigma Green Belt methodology

Roseville, Mn

Researched the effects of experimental compounds on the inhibition of allergic and inflammatory reactions, as well as researched the effects of new and novel biotherapeutic compounds on solid tumor angiogenesis. Duties included:• Research design and protocol development, grant preparation• Data analysis and presentation

St. Louis Park, Mn

Researched the mechanisms of angiogenesis in the process of wound healing. Duties included:• Research design and protocol development• Data analysis and presentation