Archives: Speakers

Nicole Leedom has over 20 years of experience in clinical research with her primary focus being rare disease indications. She is currently VP, Head of Clinical Operations at SpringWorks Therapeutics, a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer. She joined this start-up biotech company at its inception in August of 2017 where she has spent the last five and half years building out and leading the clinical operations team, executing multiple clinical trials across many different programs. Prior to joining SpringWorks, Nicole had lengthy tenures at United Therapeutics and CROs working in positions of increasing responsibilities within clinical operations, also focusing in rare diseases.

Jamie Kime is the Vice President of Clinical Operations & Procurement at Locus Biosciences. Jamie is an experienced leader focused on the operational delivery of Phase 1 – 4 clinical studies through clinical service partnerships and providers. Prior to joining Locus, he spent 18+ years at UCB Pharma in multiple leadership positions including the Global Head of Clinical Project Management and the Global Head of Outsourcing, Contracts, and Strategic Partnerships. Over the course of his career, Jamie has held positions at the Sponsor, CRO and Clinical Site providing for a well-rounded approach to operational implementation and execution of clinical studies.

Clinical Research and Development management professional for over 25 years. Full development experience from clinical coordinator to Phase I NHV unit to monitor to Global Project Manager in pharma and CROs and an oncology nurse by training. Entrepreneur who founded a CRO specializing in oncology clinical services, and acquired by Clinipace in 2009 to form a full service global CRO.

Charlene Knape is currently Vice President, Clinical Affairs at Nectero Medical. Charlene has more than 30 years of experience and leadership in key areas including Clinical Trials, Regulatory Affairs, Quality and Program Management. Along her career path Charlene has previously held various key positions including executive roles at both start-up and large corporations, including Inivata, Kiyatec, Becton Dickinson, Micell Technologies, LabCorp, EndoTex, Somnus covering a vast array of technologies focused on vascular medical device/drug combination products and the oncology personalized medicine diagnostic space.

Dr. Dworaczyk has done extensive work with numerous Healthcare, Pharma, Biotech, Healthcare, Informatics, Diagnostic and CRO companies as well as life and health science focused Venture and Private Equity investment groups assessing/evaluating investment opportunities from an operational, strategic and business perspective.

Stefan Schetter is a proven expert in the field of finance. The graduate engineer has been working in the financial sector for almost 20 years. After working for SHS Viveon and Experian, he joined CRIF GmbH as Sales Director Special Accounts and Automotive. In his position at CRIF, Stefan Schetter is mainly responsible for the areas of risk management, system and process solutions for the financial sector and KYC.