Experience

Xentria, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Director, Clinical Research

  • Jan 2022 - Present

  Xentria’s team of clinical development professionals are focused on bringing therapies to market that address critical unmet needs for suffering patients. -Develop clinical strategies and advise senior management on Xentria's pipeline of products. -Identify efficient clinical and regulatory pathways for pipeline products. -Lead clinical team members and external partners in the design and execution of clinical study programs. -Foster strategic global vendor partnerships to support the development of Xentria pipeline products. -Lead clinical operations initiatives and process development. -Influence and inform potential asset analysis. Show less

• Senior Manager, Portfolio Development & Strategy

  • Jul 2021 - Jan 2022

  -Manages decision-making processes related to Xentria's drug development pipeline. -Drive and oversee key analysis used to inform portfolio management decisions in conjunction with regulatory, operations, program management, and commercial teams.-Lead clinical protocol and program development in close collaboration with clinical operations, development, and regulatory affairs.-Develop business case for portfolio targets from concept through product lifecycles.-Lead transition of concept to operational plans.-Lead or contribute to ongoing medical affairs or special projects Show less

• Clinical Affairs Manager, Specialty Pharma

  • Jan 2020 - Jul 2021

  -Act as key member of the Clinical Development team, responsible for design, feasibility, planning, selection, set-up, conduct, and closure of global clinical trials for biologics and biosimilars.-Support clinical operations of studies, ensuring compliance with procedures, timelines, milestones, and budgets. -Act as primary communication point to key stakeholders, vendors, key opinion leaders, consultants, and clinical trial sites. -Provide program updates, risk mitigation strategies, and financial forecasts to executive-level management and international partners. Show less



Olympus Corporation of the Americas

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Senior Clinical Research Specialist (Spiration, Inc.)

  • Apr 2015 - Jan 2020

  Spiration / Olympus Respiratory America's team of scientists and researchers are passionate about developing advanced treatment options for patients suffering from acute and chronic lung conditions. -Served as primary contact and advisor to multiple clinical research sites and investigators in the United States and Canada. -Monitored clinical data to affirm adherence to clinical study protocols and international research standards. -Conducted site qualifications, site initiations, site close-outs, in-service training, and protocol training to site staff. -Provided case support for device implants and ablation procedures in the operating room and endoscopy suite environment. -Liaised with partners in Finance, Compliance, Quality, and Regulatory, as well as Contract Research Organizations, Core Labs, and Imaging Labs to design and execute clinical study protocols. -Worked on the EMPROVE Clinical Trial team to ultimately obtain FDA approval of the Spiration Valve System for the treatment of emphysema. Show less



Ann & Robert H. Lurie Children's Hospital of Chicago

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Lead Clinical Research Coordinator

  • Apr 2012 - Apr 2015

  Ann & Robert H. Lurie Children's Hospital of Chicago is the largest pediatric healthcare provider in Illinois. Lurie Children's serves as the pediatric teaching and research partner of Northwestern University Feinberg School of Medicine, and is ranked nationally in all 10 pediatric specialties by U.S. News & World Report. -Supported a strong multidisciplinary clinical research program in the Division of Pulmonary Medicine, primarily focused on cell-modulator therapies, end-point development, and long-term outcome research for Cystic Fibrosis. -Conducted patient research visits, performed pulmonary function testing, collected and analyzed samples, recorded data in accordance with ICH-GCP, and reported critical safety data to site investigators and sponsor partners. -Provided financial management on multiple projects, developed complex budgets on several multi-year clinical trials, and coordinated Clinical Trial Agreements for industry, academic, and governmental sponsors. Show less



Northwestern Memorial Hospital

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Advanced Practice Respiratory Care Practitioner, Adult Critical Care

  • May 2008 - May 2012

  Northwestern Memorial (currently Northwestern Medicine) is one of the country’s premier academic medical centers and is the primary teaching hospital of the Northwestern University Feinberg School of Medicine. -Provided respiratory therapy, ventilator management, and emergency response in a large urban Level I Trauma Center and within multiple speciality adult intensive care units. High acuity procedures included: BiLevel ventilation, Nitric Oxide administration, complex airway and ventilation strategies, emergency bronchoscopy support, advanced cardiac life support response, and practitioner-driven ventilator weaning protocols. Show less



St.Vincent Indianapolis Hospital

• United States
• Hospitals and Health Care
• 400 - 500 Employee

• Respiratory Therapy Assistant

  • May 2006 - May 2008

  St. Vincent Hospital is a large metropolitan referral hospital located in Indianapolis, Indiana. It is the flagship installation of St. Vincent Health, which operates 22 facilities in 46 Indiana counties and is one of the largest ministries in the Catholic health care organization Ascension Health. -Provided respiratory therapy in the non-intensive care setting. St. Vincent Hospital is a large metropolitan referral hospital located in Indianapolis, Indiana. It is the flagship installation of St. Vincent Health, which operates 22 facilities in 46 Indiana counties and is one of the largest ministries in the Catholic health care organization Ascension Health. -Provided respiratory therapy in the non-intensive care setting.